Overjet vs. Pearl: What the FDA 510(k) Clearance Letters Actually Say (A Side-by-Side Reading)

Most comparison articles about Overjet and Pearl compare feature lists pulled from marketing websites. Slide decks. Webinar soundbites. That is the wrong source material for a decision this consequential.

The FDA 510(k) clearance letter is the one document where a vendor had to be precise about what their tool does. Marketing copy can say anything — “AI-powered diagnostics,” “clinical-grade intelligence,” whatever sounds good on a trade show banner. The indications-for-use statement in a 510(k) filing is what the FDA actually authorized. It is specific. It is bounded. And it is legally enforceable — the vendor cannot claim the tool does things outside that statement without additional clearance.

We read the primary clearance letters for both Overjet and Pearl and compared them line by line. The differences are more granular than “Overjet does perio, Pearl does caries.” Both do caries detection. But they do it under different clearance structures, for different patient populations, with different output types. Those specifics matter if you are evaluating which tool fits your practice.

Testing honesty: We reviewed the publicly available FDA filing documents linked in the sources above. We did not deploy either tool in a clinical environment. We did not negotiate pricing with either vendor. This is a desk-based comparison of regulatory filings, vendor documentation, and confirmed partnership announcements.

What each tool is cleared to do

This is where most comparisons go wrong. They list features as if Overjet and Pearl are competing on a checklist. The regulatory reality is different: Overjet has obtained multiple separate 510(k) clearances, each authorizing a distinct function. Pearl obtained a single primary clearance that covers multiple pathology types within one filing. These are different regulatory strategies, and they produce different product architectures.

Overjet’s clearances

Overjet holds at least four primary 510(k) clearances as of early 2026 (all clearances are listed with filing details in our FDA clearance tracker):

K210187 — Dental Assist (cleared May 2021). This was Overjet’s first clearance. It authorizes AI-assisted measurement of mesial and distal alveolar bone levels on bitewing and periapical radiographs. The output is quantitative: a numerical percentage of bone level relative to root length. This is a periodontal assessment tool. The intended use population includes patients aged 5 and older (per the Charting Assist clearance that expanded on this foundation), though the original Dental Assist filing focused on adult dentition for bone level measurement.

K212519 — Caries Assist (cleared May 2022). This clearance authorizes concurrent-read CADe (computer-aided detection) software to aid detection and segmentation of caries on bitewing radiographs. The key word is “concurrent-read” — meaning the AI output is intended to be viewed alongside the clinician’s own reading, not as a pre-read or second-read workflow. The output includes probability scores for carious lesions with bounding-box segmentation.

K222746 — Caries Assist expanded (cleared March 2023). An expansion of K212519 to include periapical radiographs in addition to bitewings. Same detection function, broader radiograph scope.

K241684 — Charting Assist (cleared August 2024). Authorizes detection of tooth anatomy (enamel, pulp), tooth numbering, implants, crowns, endodontic treatment, and fillings on bitewing/periapical radiographs for patients aged 5 and older. Panoramic radiographs are included but limited to permanent dentition. This is the clearance that enables Overjet’s automated charting functionality.

There is also a CBCT Assist clearance (K243234, announced December 2025) that we have not included in this comparison because the full filing details were not reviewed at the time of writing.

Pearl’s clearances

Pearl holds eight 510(k) clearances as of early 2026, but the foundational one — the clearance most relevant to the comparison practices are making — is:

K210365 — Second Opinion (cleared March 2022). This is a concurrent and second-reader AI clearance. In a single filing, it covers detection of: caries, periapical radiolucencies, calculus, crown findings, filling findings, implant findings, bridge findings, root canal findings, and restoration margin discrepancies. The radiograph scope is bitewing and periapical. The intended use population is patients aged 16 and older with permanent teeth.

Pearl has obtained additional clearances expanding to panoramic radiographs and CBCT imaging, but K210365 is the clearance that defines the core product most practices encounter during evaluation.

The difference in structure

This structural difference is not cosmetic. Overjet’s approach — separate clearances for bone level measurement, caries detection, and charting — means each function went through its own regulatory review with its own clinical study. Pearl’s approach — multiple pathology types in a single clearance — means the FDA evaluated the multi-pathology detection capability as one system.

Neither approach is inherently better. But it means Overjet can describe the clinical evidence behind each function independently, while Pearl’s evidence base is unified. When a vendor says “our tool is 510(k) cleared for caries detection,” you should ask: is that a standalone clearance or part of a multi-condition clearance? The answer tells you something about the study design behind the claim.

The predicate device difference

Every 510(k) submission must identify a predicate device — a previously cleared product the applicant argues their device is “substantially equivalent” to. The predicate determines the regulatory category the new device enters. This is more than a bureaucratic detail. The predicate defines the ceiling of what the cleared device can claim, because it must be substantially equivalent to the predicate’s intended use.

Overjet and Pearl cited different predicate devices. The specific predicate devices are referenced in the FDA filings but not always prominently stated in press releases. What matters practically is that both tools entered the same general regulatory category — Class II medical image management and processing software — but through different predicate chains.

Why this matters for your evaluation: if a vendor tells you their tool “diagnoses” a condition, check the predicate. If the predicate device was cleared as a detection aid (CADe), the new device is cleared as a detection aid. Detection aids flag findings for clinician review. Diagnostic tools make independent determinations. These are different claims, and mixing them up — which happens constantly in dental AI marketing — is either a regulatory compliance issue or a misunderstanding. Ask the vendor which it is.

Both Overjet and Pearl are cleared as detection aids, not diagnostic tools. The dentist makes the diagnosis. The AI flags findings. This is not a limitation unique to one vendor; it is the regulatory framework both operate within.

Clinical population: who can you use these tools on?

This is the detail that pediatric practices and mixed-age practices need to pay attention to, and it is the detail most comparison articles skip entirely.

Overjet: The Charting Assist clearance (K241684) specifies patients aged 5 and older for bitewing and periapical radiographs. Panoramic radiograph analysis is limited to permanent dentition. The original caries detection clearance did not specify a pediatric age cutoff in the same way, but the charting system’s age floor creates the practical boundary for how the full Overjet suite operates in a mixed-age practice.

Pearl: The Second Opinion clearance (K210365) specifies patients aged 16 and older with permanent teeth. This is a higher age floor than Overjet’s. Pearl’s system is not cleared for use on patients with mixed dentition or primary teeth under that filing.

What this means practically: If your practice sees a significant volume of patients under 16 — pediatric dentistry, family practices, orthodontic referral practices — the Overjet suite has a lower age threshold. Pearl’s 16+ restriction means the AI will not be running on a meaningful portion of your patient population if you see children and adolescents regularly.

This is not about which tool is “better.” It is about which tool’s clearance matches your patient demographics. A practice that sees exclusively adults will not care about this distinction. A practice where 30% of patients are under 16 should care a lot.

One caveat: both companies may have obtained additional clearances or expanded age ranges since their primary filings. Check the current clearance status directly with the vendor and cross-reference against the FDA database before making a purchasing decision based on age ranges.

Quantitative vs. qualitative outputs: the fundamental tradeoff

This is the most important technical difference between the two products, and it is the one that should drive your evaluation more than any other factor.

Overjet produces numerical measurements. The bone level measurement in Dental Assist outputs a percentage — radiographic bone level as a percentage of root length, measured at mesial and distal sites. The caries detection in Caries Assist outputs probability scores for identified carious regions, with segmentation overlays showing the extent of the lesion. These are numbers your hygienist and your treatment coordinator can point to on a screen and reference in a case presentation.

Pearl produces detection flags across more conditions. The Second Opinion clearance covers nine distinct finding categories in a single system. The output is identification and highlighting — the AI marks areas where it detects pathology and categorizes the finding type. The breadth of coverage means Pearl is looking at more things per radiograph, but the output format is detection-and-classification rather than quantitative measurement.

Why this tradeoff matters in your operatory

If you are building a periodontal program and want to show patients objective measurements of bone loss over time — trending bone levels across recall visits, showing a patient that their bone level went from 72% to 65% in the mesial of tooth 30 — Overjet’s quantitative output supports that workflow directly. The number becomes part of the clinical conversation.

If you want a broad screening tool that catches things you might miss on a busy Tuesday afternoon — calculus you didn’t flag, a margin discrepancy on an old crown, a periapical radiolucency on a tooth the patient isn’t complaining about — Pearl’s multi-pathology detection casts a wider net.

These are different clinical philosophies, not different quality levels. A practice focused on perio case acceptance might weight Overjet’s measurement capabilities more heavily. A practice focused on comprehensive detection coverage might weight Pearl’s breadth. A practice that wants both is going to need both — or wait for one vendor to expand into the other’s territory, which both companies are clearly working toward.

PMS integrations compared

Integration with your practice management system is not a “nice to have.” If the AI tool does not write its findings back to the patient chart in a format your team can use during treatment presentation, it adds a step to your workflow instead of removing one. “View in a separate window” is not integration. “Findings auto-populate in the patient record” is integration.

Here is what we have confirmed from official partnership announcements, vendor documentation, and publicly available information as of February 2026:

What this means for your decision:

If you are on Dentrix, Eaglesoft, or Open Dental — which covers the majority of US dental practices — both tools are available to you. Your integration choice should be based on the clinical function differences described above, not integration availability.

If you are on Curve or CareStack — Pearl is your option. Overjet has not confirmed integration with either platform in the documentation we reviewed.

If you are on Archy or another cloud-based PMS not listed here — check with both vendors directly. Integration status changes, and smaller PMS platforms are being added as both companies expand their partnership networks.

A note on integration depth: “Confirmed integration” does not mean the integration works identically across platforms. The depth of integration — whether AI findings auto-attach to the patient chart, whether they appear inline in the clinical notes or as a separate attachment, whether the imaging viewer is embedded in the PMS or launches separately — varies by platform and by vendor. Ask for a demo on YOUR PMS, not a generic demo on whatever PMS the sales team prefers to show.

What we don’t know

This section matters as much as the comparison above. A responsible evaluation acknowledges the limits of a desk-based comparison, and here are ours.

Pricing. Neither Overjet nor Pearl publishes pricing on their website. Both require a sales conversation. We have not negotiated contracts with either vendor. Pricing models reportedly differ — Overjet has been described in practitioner forums as per-provider, Pearl as per-location — but we cannot verify specific dollar amounts. See our dental AI pricing guide for more on pricing structures and what to ask on the sales call.

Real-world sensitivity and specificity. Both vendors publish accuracy metrics. These come from their 510(k) submission studies or separate validation studies. We have not evaluated how either tool performs on radiographs from YOUR imaging hardware, in YOUR operatory conditions, with YOUR patient population. Study populations and real-world populations are different. Ask each vendor for the specifics of their validation dataset: how many images, from how many sites, what imaging equipment, what patient demographics.

Hygienist and assistant adoption rates. The best AI tool in the world is useless if your hygienist ignores the overlay or your assistant does not know how to present the findings to the patient. We have no data on how quickly clinical teams adopt either tool, how much training is required, or what the dropout curve looks like after the first month. This is a question for practices that have deployed each tool, and it is a question vendors should be willing to connect you with reference practices to answer.

Chairside workflow impact. Does adding AI to your imaging workflow add time or save time? Does the hygienist stop to review the AI overlay during the initial exam, or is it reviewed during the doctor exam? Does the treatment coordinator use the AI findings in case presentation, or does the current workflow not include that step? These are practice-specific questions that cannot be answered from a clearance letter.

Long-term cost trajectory. Both companies are venture-backed and growing. Pricing today may not be pricing in two years. Contract terms, price escalation clauses, and what happens if you want to switch vendors are all questions for the sales call — and the contract review your attorney should do before you sign.

Which one should you evaluate first?

This is not a “winner” declaration. It is a routing framework based on what your practice actually needs.

Evaluate Overjet first if:

• Your primary interest is periodontal measurement — quantitative bone level data you can trend over time and use in case presentations
• You see patients aged 5-15 regularly and need the AI to cover that population
• Your practice emphasis is on perio case acceptance and you want numbers to support the conversation
• You are already planning to build a perio-focused workflow and want the AI tool that supports measurement, not just detection

Evaluate Pearl first if:

• You want the broadest pathology coverage in a single tool — detection across caries, periapical radiolucencies, calculus, margins, and existing restorations
• You are on Curve or CareStack (Pearl is currently the only option with confirmed integration)
• Your primary use case is comprehensive detection during routine exams — catching things that might be missed, not measuring things you already know about
• You want a tool that identifies margin discrepancies on existing restorations, which is part of Pearl’s clearance but not Overjet’s primary clearance scope

Evaluate both if:

• You are a multi-location practice or DSO with the budget and operational bandwidth to pilot each tool at different locations
• You want measurement AND broad detection and can justify two subscriptions (check whether contractual terms from either vendor prohibit running a competitor’s tool simultaneously)

Wait if:

• Neither tool integrates with your PMS and you are not willing to change PMS platforms
• Your imaging hardware is outdated and you are planning to upgrade sensors or machines in the next 12 months (evaluate after the upgrade, so the demo reflects your actual image quality)
• You are not sure what clinical problem you are trying to solve with AI — “we should probably have AI” is not a use case, and buying a tool without a defined workflow for using it is how expensive software becomes expensive shelfware

What this comparison cannot tell you

We read clearance letters. We compared regulatory filings. We verified integration claims against official documentation. That is useful information, and it is more reliable than a feature comparison pulled from marketing websites.

But it cannot tell you:

How accurate the tool is on your radiographs. Clinical accuracy is a function of image quality, patient population, lesion prevalence, and the specific imaging hardware generating the radiographs. A tool that performs well on digital sensors from one manufacturer may perform differently on sensors from another. The only way to evaluate accuracy in your operatory is to run the tool on your images and compare its findings to your clinical judgment. Both vendors should offer a pilot or trial period. If they do not, that is a data point.

Whether your team will use it. Technology adoption in a dental practice is not a technology problem. It is a change management problem. The best AI tool will sit unused if the clinical team does not trust it, does not understand the output, or does not have a defined step in the workflow where the AI findings are reviewed and discussed. Before you evaluate the software, decide: at what point in the patient visit will AI findings be reviewed? Who reviews them? How are they presented to the patient? If you cannot answer those questions, the tool evaluation is premature.

Whether the ROI pencils out. Both vendors will present ROI models showing increased case acceptance, reduced missed diagnoses, and revenue uplift. Those models are based on assumptions about your practice’s current miss rate, your case acceptance rate, and your fee schedule. The only ROI number that matters is the one you calculate from your own data after running the tool for six months. Ask the vendor for their ROI model, but run your own numbers.

What happens in two years. Both companies are expanding rapidly. Overjet is adding clearances (CBCT Assist is the latest). Pearl is adding PMS integrations and expanding pathology coverage. The competitive landscape in dental AI is moving fast enough that a comparison written today may not fully reflect the products available in 12 months. Check the FDA database and vendor documentation at evaluation time, not publication time.

This comparison is a starting point. The clearance letters tell you what each tool is authorized to do. Everything else — accuracy in your setting, team adoption, workflow fit, financial return — is yours to evaluate. Do the pilot. Run the numbers. Talk to practices that have deployed each tool. And read the contract before you sign it.

Source verification note

All FDA clearance numbers and indications-for-use statements in this article are sourced from the FDA 510(k) Premarket Notification Database and the decision letters linked in the sources section above. PMS integration status is sourced from official partnership announcements and vendor documentation reviewed as of the date shown in lastVerified. If you identify an error in any clearance number, date, indication statement, or integration claim, contact us and we will correct it with a noted update.