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FDA 510(k)

GC TEMPRON

K-Number: K935960 · 1994-03-04

ApplicantGC America, Inc.
Decision Date1994-03-04
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC TEMPRON is the device name listed in this FDA 510(k) record. The listed applicant is GC America, Inc.. It received FDA 510(k) clearance on 1994-03-04 under 510(k) number K935960. 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 GC TEMPRON?

GC TEMPRON is a medical device that received FDA 510(k) clearance on 1994-03-04. The listed applicant is GC America, Inc.. The 510(k) number is K935960.

When did GC TEMPRON receive FDA 510(k) clearance?

GC TEMPRON received FDA 510(k) clearance on 1994-03-04, under 510(k) number K935960.

Who is the listed applicant for GC TEMPRON?

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

What is the FDA product code for GC TEMPRON?

The FDA product code for GC TEMPRON is EBG.

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Other records listing GC America, Inc. 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.

K262202Cerasmart ForteK253317Cytrans™ ElashieldK261246SRGC-06K254109G-CEM UNIVERSALK251124G-Bond UniversalK250953EQUIA LC ONE

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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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