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FDA 510(k)

C-30 Crown Kit

K-Number: K211345 · 2021-11-24

ApplicantPerfect Fit Crowns, LLC
Decision Date2021-11-24
Product CodeEBF
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

C-30 Crown Kit is a medical device manufactured by Perfect Fit Crowns, LLC. It received FDA 510(k) clearance on 2021-11-24 under approval number K211345. 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 C-30 Crown Kit?

C-30 Crown Kit is a medical device that received FDA 510(k) clearance on 2021-11-24. It is manufactured by Perfect Fit Crowns, LLC. The 510(k) number is K211345.

When was C-30 Crown Kit approved by the FDA?

C-30 Crown Kit received FDA 510(k) clearance on 2021-11-24, under approval number K211345.

What company makes C-30 Crown Kit?

C-30 Crown Kit is manufactured by Perfect Fit Crowns, LLC.

What is the FDA product code for C-30 Crown Kit?

The FDA product code for C-30 Crown Kit is 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.

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