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FDA 510(k)

BREFORMANCE

K-Number: K052781 · 2005-12-09

ApplicantBredent-Products For the Dental Technician Laborat
Decision Date2005-12-09
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BREFORMANCE is the device name listed in this FDA 510(k) record. The listed applicant is Bredent-Products For the Dental Technician Laborat. It received FDA 510(k) clearance on 2005-12-09 under 510(k) number K052781. The device is classified under product code EBG. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREFORMANCE?

BREFORMANCE is a medical device that received FDA 510(k) clearance on 2005-12-09. The listed applicant is Bredent-Products For the Dental Technician Laborat. The 510(k) number is K052781.

When did BREFORMANCE receive FDA 510(k) clearance?

BREFORMANCE received FDA 510(k) clearance on 2005-12-09, under 510(k) number K052781.

Who is the listed applicant for BREFORMANCE?

The FDA 510(k) record lists Bredent-Products For the Dental Technician Laborat as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BREFORMANCE?

The FDA product code for BREFORMANCE is EBG.

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 Bredent-Products For the Dental Technician Laborat 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.

K052780DENTAPLAST HOT, MODEL 16-XXXK052779BRECOMP

Related Devices (Code: EBG)

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.

K261261Dura-ArchHangzhou SHINING3D Dental Technology Co., Ltd.K253380“FLNT Base” and “FLNT Temp”Liaoning Upcera Co., Ltd.K251271TempFIT Temporary Crown and Bridge ResinRizhao Huge Biomaterials Company, Ltd.K243370DentaTOOTHAsiga Pty, Ltd.K243621Evoblock, PerléonEvoden Indústria Comércio Importação E ExportaçãoK243951TEMP MASTER, PMMA-based dental resinTaiwan Dental Materials Co., Ltd.

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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