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FDA 510(k)

GC PATTERN RESIN

K-Number: K942670 · 1994-10-18

ApplicantGC America, Inc.
Decision Date1994-10-18
Product CodeEBG
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

GC PATTERN RESIN 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 1994-10-18 under 510(k) number K942670. 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 PATTERN RESIN?

GC PATTERN RESIN is a medical device that received FDA 510(k) clearance on 1994-10-18. The listed applicant is GC America, Inc.. The 510(k) number is K942670.

When did GC PATTERN RESIN receive FDA 510(k) clearance?

GC PATTERN RESIN received FDA 510(k) clearance on 1994-10-18, under 510(k) number K942670.

Who is the listed applicant for GC PATTERN RESIN?

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 PATTERN RESIN?

The FDA product code for GC PATTERN RESIN is EBG.

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Other records listing GC America, Inc. as applicant

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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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