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FDA 510(k)

FIXTEMP C&B

K-Number: K102917 · 2011-06-17

ApplicantExacta Dental Direct, Inc.
Decision Date2011-06-17
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

FIXTEMP C&B is the device name listed in this FDA 510(k) record. The listed applicant is Exacta Dental Direct, Inc.. It received FDA 510(k) clearance on 2011-06-17 under 510(k) number K102917. 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 FIXTEMP C&B?

FIXTEMP C&B is a medical device that received FDA 510(k) clearance on 2011-06-17. The listed applicant is Exacta Dental Direct, Inc.. The 510(k) number is K102917.

When did FIXTEMP C&B receive FDA 510(k) clearance?

FIXTEMP C&B received FDA 510(k) clearance on 2011-06-17, under 510(k) number K102917.

Who is the listed applicant for FIXTEMP C&B?

The FDA 510(k) record lists Exacta Dental Direct, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FIXTEMP C&B?

The FDA product code for FIXTEMP C&B is EBG.

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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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