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FDA 510(k)

CERAMIR CROWN & BRIDGE

K-Number: K113040 · 2011-12-28

ApplicantDoxa Dental AB
Decision Date2011-12-28
Product CodeEMA
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

CERAMIR CROWN & BRIDGE 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 2011-12-28 under 510(k) number K113040. 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 CROWN & BRIDGE?

CERAMIR CROWN & BRIDGE is a medical device that received FDA 510(k) clearance on 2011-12-28. The listed applicant is Doxa Dental AB. The 510(k) number is K113040.

When did CERAMIR CROWN & BRIDGE receive FDA 510(k) clearance?

CERAMIR CROWN & BRIDGE received FDA 510(k) clearance on 2011-12-28, under 510(k) number K113040.

Who is the listed applicant for CERAMIR CROWN & BRIDGE?

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 CROWN & BRIDGE?

The FDA product code for CERAMIR CROWN & BRIDGE is EMA.

Related Clinical Trials

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.

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Other records listing Doxa Dental AB as applicant

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.

K201937Ceramir Restore QuikCapK081405XERACEM

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.

K262983EsTemp ImplantSpident Co., Ltd.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.

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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