Pearl Second Opinion Review: Dental X-Ray AI With Eight FDA Clearances

Pearl’s Second Opinion flags suspected caries, bone levels and other findings on dental X-rays. We checked its eight FDA clearances, three studies that name it and what users say on Capterra.

By 6thSolution TeamPublished 10 min read

Pearl Second Opinion review

Second Opinion is Pearl Inc.’s AI software for dental X-rays. It marks suspected caries, calculus, periapical radiolucencies, bone levels and existing restorations on bitewing and periapical images, some findings on panoramic images, and a separate version segments anatomy on CBCT scans. The FDA has cleared it eight times since 2022, though some findings the vendor advertises fall outside those clearances.

Quick verdict

Second Opinion suits general practices and groups that take a lot of intraoral X-rays and want a consistent second look plus visuals they can show patients. The FDA records back up the core use: helping dentists spot suspected caries, periapical lesions and bone levels, with the dentist making the call. We found three studies in PubMed that name it, and the accuracy figures on Pearl’s site aren’t ones we could match to a published abstract. On Capterra, where Pearl has four reviews, most reviewers like it for patient conversations, and two report findings that turned out to be wrong. Ask for a demo on your own images, and check that your imaging software is on Pearl’s integration list.

Pearl Second Opinion at a glance

Vendor Pearl Inc.
What it does Marks suspected findings on 2D dental X-rays; Second Opinion 3D segments anatomy on CBCT scans
Who it’s for Dentists, DSOs and dental schools (the vendor’s own groups)
Pricing Pricing on request (checked October 19, 2026)
FDA status FDA 510(k) cleared: eight clearances, most recent K250525 (November 14, 2025)
HIPAA / BAA Not stated on the Second Opinion page. Pearl’s Practice Intelligence and Voice pages list HIPAA, SOC 2 Type II and ISO 13485. No mention of a BAA.
Integrations The vendor says 40+ imaging and practice management systems, including DEXIS, Carestream, Romexis, Sidexis, Apteryx XVWeb, MiPACS, Open Dental, Eaglesoft, Curve and Dentally
User rating 4.3 out of 5 from 4 reviews on Capterra (checked October 19, 2026)
Data checked October 19, 2026

What is Pearl Second Opinion?

Pearl Second Opinion is FDA-cleared software that marks suspected findings on dental X-rays, and anatomy on CBCT scans, for the dentist to review. The dentist makes every call. Pearl says it works inside a practice’s existing imaging software, if that software is supported, or as a standalone web app.

Pearl says Second Opinion connects to a practice’s imaging software and analyzes each bitewing, periapical or panoramic image as it’s captured. The vendor says it marks up to 18 findings per image and that most images are processed in seconds. According to Pearl’s FAQ, detections appear inside your existing imaging workflow, and there’s also a standalone web app.

Pearl sells it alongside other products: Practice Intelligence (practice analytics), RCM (insurance and claims), Voice (clinical notes and perio charting), Calibrate (clinical training) and Second Opinion 3D for CBCT. Of these, only Second Opinion and Second Opinion 3D hold FDA clearances.

The FDA summaries describe Second Opinion as software that aids dental professionals. The software suggests areas to look at; the dentist decides what each one is.

Key features

Second Opinion’s main features are color-coded findings on X-rays, tooth-by-tooth measurements, image quality checks and patient-facing reports, according to Pearl’s product pages:

  • Color-coded marks for incipient and progressed decay, bone loss, calculus, periapical radiolucencies, margins and restorations (from the vendor’s feature list)
  • “Affected Tooth %”: the share of each tooth affected by caries or restoration, with enamel, dentin and pulp shown separately
  • Imagecheck, which the vendor says flags underexposure, cone cuts and positioning errors
  • A pediatric view with “sugar bugs” overlays for children’s caries
  • Progression views and exportable patient reports for case presentation and insurance submissions
  • Intraoral and extraoral photos viewable inside Second Opinion
  • Second Opinion 3D: color-coded CBCT anatomy, measurements, and one-click requests for a report from a board-certified oral and maxillofacial radiologist

Pearl Second Opinion vs. what an imaging AI tool should have

Pearl Second Opinion meets most of what we look for in imaging AI: FDA clearances, support for 40+ imaging and practice systems (per Pearl) and dentist-confirmed findings. The gaps are advertised findings outside the clearances, CBCT pathology detection that Pearl says is available only in Canada, no BAA statement, no described chart write-back and no public pricing.

Must have

Feature Status Note
FDA clearance for each advertised finding Partial Widened periodontal ligament, which the vendor lists, isn’t in the FDA indications we read; CBCT pathology detection is Canada only, per the vendor
Works with your imaging software Listed From the vendor’s list of 40+ imaging and practice systems: DEXIS, Carestream, Romexis, Sidexis, Apteryx XVWeb, MiPACS and others
Works with your practice management system Listed Same list includes Open Dental, Eaglesoft, Curve, Dentally and Tab32; writing findings back to the chart isn’t described
Dentist reviews every finding FDA listing Cleared to aid dental professionals, mostly as a second reader
Image types covered FDA listing Bitewing, periapical, panoramic and CBCT, covered by different clearances
Data protection details Partial HIPAA and SOC 2 Type II listed on other Pearl product pages; no BAA mentioned

Should have

Feature Status Note
Published study that names the product Study Three studies; two by researchers in Saudi Arabia (one also in India)
Patient-facing view for chairside explanations Listed Most Capterra reviewers mention it too
Pediatric use covered FDA listing Second Opinion Pediatric, patients aged 4 and older
Public pricing Not listed

Nice to have

Feature Status Note
CBCT analysis FDA listing Anatomy segmentation in the US
Insurance and claims support Listed Patient reports for insurance submissions; claim-ready CBCT documentation
Practice analytics Listed A separate Pearl product, Practice Intelligence

What the research says

Three studies in PubMed name Second Opinion, though none of the abstracts names Pearl as the vendor. They measure different things and report different results. A 2025 study of 300 periapical radiographs by researchers in Saudi Arabia and India reported 91.0% sensitivity for caries, while a 2026 study of 200 bitewings found that five commercial systems, Second Opinion among them, missed many caries lesions next to restorations.

We found three published studies in PubMed that name Second Opinion. Two come from researchers in Saudi Arabia (one with a co-author from a clinic in India), and the third abstract doesn’t say where its images came from. Where the abstracts list author affiliations, none is Pearl, and none of the abstracts says who funded the work.

Secondary caries on bitewings (Caries Research, 2026). A cross-sectional study of 200 anonymized bitewings with 885 restored tooth surfaces compared five commercial AI systems, Second Opinion among them, with three experimental ones. Across all systems, specificity was high (0.957 to 0.986) and sensitivity was moderate (0.327 to 0.487), so the tools missed many caries lesions next to restorations, particularly in dentin. Accuracy ranged from 0.882 to 0.917, with no statistically significant difference between the systems. The abstract doesn’t report Second Opinion’s numbers on their own, and it doesn’t say where the images came from.

Periapical radiographs (Diagnostics, 2025). Researchers from universities in Saudi Arabia and a clinic in India tested Second Opinion version 1.1 on 300 periapical radiographs covering 1,030 teeth, against labels from two oral radiologists. The abstract reports sensitivity of 91.0% for caries, 86.6% for periapical lesions and 91.1% for marginal bone loss, with specificity of 87%, 98.3% and 93.1% for the same findings. Thirty dental interns and thirty specialists then read five images each, without and then with the software, and their accuracy was higher with it.

Alveolar bone loss (Journal of Taibah University Medical Sciences, 2025). A cross-sectional study from Saudi Arabia compared bone loss estimates from 149 survey responses by dental practitioners with measurements by software the abstract calls “Second Opinion Software”. The software’s measurements correlated more strongly with the radiographic measurements (rho = 0.712) than the practitioners’ estimates did (rho = 0.547). The abstract doesn’t name the vendor.

Pearl’s own site gives different figures. It says Second Opinion is 94% accurate, validated by an independent third party, and elsewhere says “over 95% accuracy”. It also says operator accuracy rose from 82% to 98% in a published clinical study and that practices find 37% more disease. We couldn’t match those figures to the abstracts we found, so treat them as the vendor’s claims.

FDA status and privacy

The FDA’s 510(k) database lists eight clearances for Pearl, Inc. Each covers one product and a defined use:

Device 510(k) Cleared What the FDA summary says it does
Second Opinion K210365 March 4, 2022 Marks suspected caries, margin discrepancies, calculus, periapical radiolucency and restorations on bitewings and periapicals, age 12 and older, as a second reader
Second Opinion CC K242522 January 16, 2025 Draws outlines around suspected caries on bitewings and periapicals, age 19 and older, as a second reader
Second Opinion Periapical Radiolucency Contours K242600 April 11, 2025 Outlines suspected periapical radiolucencies on periapicals, age 12 and older, as a second reader
Second Opinion Pediatric K243893 May 5, 2025 Aids caries detection on bitewings and periapicals in patients aged 4 and older
Second Opinion BLE K243230 May 9, 2025 Displays bone level measurements on bitewings and periapicals, age 12 and older
Second Opinion 3D K243989 May 23, 2025 Marks anatomy on CBCT scans (teeth, jaws, nerve canal, sinus, nasal space, airway), age 12 and older
Second Opinion CS K243234 June 12, 2025 Aids detection and outlining of caries on periapicals, age 12 and older, as a second reader
Second Opinion Panoramic K250525 November 14, 2025 Marks suspected caries, periapical radiolucency and impacted third molars on panoramic images, age 16 and older

Two details matter when you compare this list with the marketing. The 3D clearance covers anatomy only; the vendor says pathology detection on CBCT is available in Canada, with clearances for other regions pending. And several summaries call the software a “second reader”, with the panoramic, BLE and 3D summaries adding “concurrent” reader. Those three summaries also say the software shouldn’t be used in place of a full patient evaluation.

On privacy, the Second Opinion page doesn’t describe data handling. Pearl’s Practice Intelligence page lists HIPAA, GDPR, SOC 2 Type II and ISO 13485 under enterprise security, and the Voice page says the Pearl suite uses AES-256 encryption at rest and TLS 1.2/1.3 in transit. We didn’t find a mention of a business associate agreement (BAA), so ask for one before you connect patient images.

Pricing

Pricing on request. Pearl doesn’t publish prices for Second Opinion, and its product pages ask you to book a demo. Checked October 19, 2026.

Pros (from user reviews)

  • Most reviewers on Capterra say it makes findings easier to explain to patients, and two credit the colors and visuals.
  • One dentist owner says it picked up things they wouldn’t have seen and that onboarding and support were good.
  • One reviewer says it works smoothly with their practice management and radiology software.

Cons (from user reviews)

  • Two reviewers say it isn’t always accurate. One mentions cervical burnout being flagged, which then had to be explained to patients as an artifact; the other mentions many false positives for interproximal decay. A third says the AI isn’t as well trained as other systems.
  • One reviewer finds support hard to reach and says the colors for anatomy and caries could be easier to tell apart.
  • With only four reviews, these themes are a small sample. Capterra labels one of the four as an incentivized review.

Who it’s for

Second Opinion fits practices that want every intraoral X-ray read a second time and want visuals for case presentation, especially if their imaging software is on Pearl’s integration list. One reviewer who switched from Overjet says their X-ray imaging software is only partnered with Pearl, so check compatibility first.

It’s a weaker fit if you need CBCT pathology detection in the US, which the vendor says is available only in Canada for now, or if you want published prices before a sales call. And if false positives would cause friction with patients, ask the vendor how it handles them before you show the screen chairside.

FAQ

Is Pearl Second Opinion FDA cleared?

Yes. The FDA’s 510(k) database lists eight clearances for Pearl, Inc., from the original Second Opinion (K210365, March 4, 2022) to Second Opinion Panoramic (K250525, November 14, 2025). Each clearance covers specific findings, image types and patient ages.

Does Second Opinion replace the dentist’s diagnosis?

No. The FDA summaries describe software that aids dental professionals, often as a second reader, and three of them say it shouldn’t be used in place of a full patient evaluation. The dentist decides on every finding.

How accurate is Pearl Second Opinion?

Pearl says 94% accuracy, and elsewhere over 95%. A 2025 study of 300 periapical radiographs, by researchers in Saudi Arabia and India, reported 91.0% sensitivity and 87% specificity for caries. A 2026 study of 200 bitewings found that five commercial systems, including Second Opinion, missed many caries lesions next to restorations.

How much does Pearl Second Opinion cost?

Pricing on request. Pearl doesn’t publish prices for Second Opinion on its product pages, which ask practices to book a demo instead (checked October 19, 2026).

Which imaging software does Pearl Second Opinion work with?

Pearl says Second Opinion integrates with 40+ imaging and practice management systems, including DEXIS, Carestream, Romexis, Sidexis, Apteryx XVWeb, MiPACS, Open Dental, Eaglesoft, Curve and Dentally. It’s also available as a standalone web app. Check your exact system with Pearl’s sales team.

Does it work with CBCT scans?

Second Opinion 3D is FDA cleared to mark anatomy on CBCT scans, such as the nerve canal and sinus. The vendor says pathology detection on CBCT is currently available only in Canada.

How this review was put together

We didn’t use Second Opinion ourselves. This review is built from Pearl’s product pages, the FDA’s 510(k) and PMA databases, three studies found in PubMed, and all four user reviews of Pearl on Capterra, written between December 17, 2023 and May 26, 2026. All sources were checked on October 19, 2026.

Sources

  1. Pearl: Second Opinion product page, accessed October 19, 2026
  2. Pearl: Second Opinion 3D product page, accessed October 19, 2026
  3. Pearl: home page, accessed October 19, 2026
  4. Pearl: Practice Intelligence page, accessed October 19, 2026
  5. Pearl: Voice page, accessed October 19, 2026
  6. Pearl: RCM page, accessed October 19, 2026
  7. Pearl: Calibrate page, accessed October 19, 2026
  8. FDA 510(k) K210365, Second Opinion, accessed October 19, 2026
  9. FDA 510(k) K242522, Second Opinion CC, accessed October 19, 2026
  10. FDA 510(k) K242600, Second Opinion Periapical Radiolucency Contours, accessed October 19, 2026
  11. FDA 510(k) K243893, Second Opinion Pediatric, accessed October 19, 2026
  12. FDA 510(k) K243230, Second Opinion BLE, accessed October 19, 2026
  13. FDA 510(k) K243989, Second Opinion 3D, accessed October 19, 2026
  14. FDA 510(k) K243234, Second Opinion CS, accessed October 19, 2026
  15. FDA 510(k) K250525, Second Opinion Panoramic, accessed October 19, 2026
  16. AI-Based Clinical Decision Support Systems for Secondary Caries Detection and Staging on Bitewings, Caries Research (2026), accessed October 19, 2026
  17. Assessment of the Diagnostic Accuracy of Artificial Intelligence Software … in Intraoral Periapical Radiographs, Diagnostics (2025), accessed October 19, 2026
  18. Dental practitioners versus artificial intelligence software in assessing alveolar bone loss, Journal of Taibah University Medical Sciences (2025), accessed October 19, 2026
  19. Capterra: Pearl reviews, accessed October 19, 2026