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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 the device name listed in this FDA 510(k) record. The listed applicant is Doxa Dental AB. It received FDA 510(k) clearance on 2020-11-13 under 510(k) 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. The listed applicant is Doxa Dental AB. The 510(k) number is K201937.

When did Ceramir Restore QuikCap receive FDA 510(k) clearance?

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

Who is the listed applicant for Ceramir Restore QuikCap?

The FDA 510(k) record lists Doxa Dental AB as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ceramir Restore QuikCap?

The FDA product code for Ceramir Restore QuikCap is EMA.

Related Devices (Code: EMA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254201Any-CemMediclus Co., Ltd.K261937PacTemp Automix NEThe Belport Company Inc., DBA Gingi-PakK261166DIA-CEMDiaDent Group InternationalK254109G-CEM UNIVERSALGC America, Inc.K253337REGEN Bioactive CementInter-Med, Inc.K252606Bifix Veneer LC, Bifix Veneer Try-InVoco GmbH

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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