Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Second Opinion Periapical Radiolucency Contours

K-Number: K242600 · 2025-04-11

ApplicantPearl, Inc.
Decision Date2025-04-11
Product CodeMYN
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Second Opinion Periapical Radiolucency Contours is the device name listed in this FDA 510(k) record. The listed applicant is Pearl, Inc.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K242600. The device is classified under product code MYN. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Second Opinion Periapical Radiolucency Contours?

Second Opinion Periapical Radiolucency Contours is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Pearl, Inc.. The 510(k) number is K242600.

When did Second Opinion Periapical Radiolucency Contours receive FDA 510(k) clearance?

Second Opinion Periapical Radiolucency Contours received FDA 510(k) clearance on 2025-04-11, under 510(k) number K242600.

Who is the listed applicant for Second Opinion Periapical Radiolucency Contours?

The FDA 510(k) record lists Pearl, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Second Opinion Periapical Radiolucency Contours?

The FDA product code for Second Opinion Periapical Radiolucency Contours is MYN.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07546279The Use of Two Bone Substitutes in Adjunct to EMD for the Treatment of One- and Two-wall Intrabony Defects.RECRUITING

Other records listing Pearl, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K250525Second Opinion® PanoramicK243234Second Opinion® CSK243989Second Opinion® 3DK243230Second Opinion® BLEK243893Second Opinion® PediatricK242522Second Opinion CC

View all 8 devices →

Related Devices (Code: MYN)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261059Overjet Multi-Image Caries and Charting AssistOverjet, Inc.K260851Better Diagnostics Dental Assist (BDDA) Version 1.0Better Diagnostics AI Corp.K252953Velmeni for Dentists (V4D) Endo-PerioVelmeni, Inc.K251934qXR-DetectQure.Ai TechnologiesK252934DiagnocatDGNCT, LLCK253009DS Core DetectDentsply Sirona, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑