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FDA 510(k)

Solea

K-Number: K221761 · 2022-09-14

ApplicantConvergent Dental, Inc.
Decision Date2022-09-14
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Solea is a medical device manufactured by Convergent Dental, Inc.. It received FDA 510(k) clearance on 2022-09-14 under approval number K221761. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Solea?

Solea is a medical device that received FDA 510(k) clearance on 2022-09-14. It is manufactured by Convergent Dental, Inc.. The 510(k) number is K221761.

When was Solea approved by the FDA?

Solea received FDA 510(k) clearance on 2022-09-14, under approval number K221761.

What company makes Solea?

Solea is manufactured by Convergent Dental, Inc..

What is the FDA product code for Solea?

The FDA product code for Solea is NVK.

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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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