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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 a medical device manufactured by Pearl, Inc.. It received FDA 510(k) clearance on 2025-04-11 under approval 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. It is manufactured by Pearl, Inc.. The 510(k) number is K242600.

When was Second Opinion Periapical Radiolucency Contours approved by the FDA?

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

What company makes Second Opinion Periapical Radiolucency Contours?

Second Opinion Periapical Radiolucency Contours is manufactured by Pearl, Inc..

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

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

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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.

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