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FDA 510(k)

EdgePro

K-Number: K213428 · 2021-12-22

ApplicantBiolase, Inc.
Decision Date2021-12-22
Product CodeNVK
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

EdgePro is a medical device manufactured by Biolase, Inc.. It received FDA 510(k) clearance on 2021-12-22 under approval number K213428. 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 EdgePro?

EdgePro is a medical device that received FDA 510(k) clearance on 2021-12-22. It is manufactured by Biolase, Inc.. The 510(k) number is K213428.

When was EdgePro approved by the FDA?

EdgePro received FDA 510(k) clearance on 2021-12-22, under approval number K213428.

What company makes EdgePro?

EdgePro is manufactured by Biolase, Inc..

What is the FDA product code for EdgePro?

The FDA product code for EdgePro 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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