FDA 510(k)

OptiComp

K-Number: K202920 · 2022-05-25

Decision Date2022-05-25

Product CodeEBF

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

OptiComp is a medical device manufactured by Pac-Dent, Inc.. It received FDA 510(k) clearance on 2022-05-25 under approval number K202920. The device is classified under product code EBF. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OptiComp?

OptiComp is a medical device that received FDA 510(k) clearance on 2022-05-25. It is manufactured by Pac-Dent, Inc.. The 510(k) number is K202920.

When was OptiComp approved by the FDA?

OptiComp received FDA 510(k) clearance on 2022-05-25, under approval number K202920.

What company makes OptiComp?

OptiComp is manufactured by Pac-Dent, Inc..

What is the FDA product code for OptiComp?

The FDA product code for OptiComp is EBF.

Other Devices by Pac-Dent, Inc.

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Related Devices (Code: EBF)

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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.