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FDA 510(k)

Ceramir Restore QuikCap

K-Number: K201937 · 2020-11-13

ApplicantDoxa Dental AB
Decision Date2020-11-13
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Ceramir Restore QuikCap is a medical device manufactured by Doxa Dental AB. It received FDA 510(k) clearance on 2020-11-13 under approval number K201937. The device is classified under product code EMA. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Ceramir Restore QuikCap?

Ceramir Restore QuikCap is a medical device that received FDA 510(k) clearance on 2020-11-13. It is manufactured by Doxa Dental AB. The 510(k) number is K201937.

When was Ceramir Restore QuikCap approved by the FDA?

Ceramir Restore QuikCap received FDA 510(k) clearance on 2020-11-13, under approval number K201937.

What company makes Ceramir Restore QuikCap?

Ceramir Restore QuikCap is manufactured by Doxa Dental AB.

What is the FDA product code for Ceramir Restore QuikCap?

The FDA product code for Ceramir Restore QuikCap is EMA.

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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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