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FDA 510(k)

XENEX DENTAL ROULETTE

K-Number: K880485 · 1988-05-02

ApplicantG & A Industries, Inc.
Decision Date1988-05-02
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

XENEX DENTAL ROULETTE is the device name listed in this FDA 510(k) record. The listed applicant is G & A Industries, Inc.. It received FDA 510(k) clearance on 1988-05-02 under 510(k) number K880485. The device is classified under product code EFW. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the XENEX DENTAL ROULETTE?

XENEX DENTAL ROULETTE is a medical device that received FDA 510(k) clearance on 1988-05-02. The listed applicant is G & A Industries, Inc.. The 510(k) number is K880485.

When did XENEX DENTAL ROULETTE receive FDA 510(k) clearance?

XENEX DENTAL ROULETTE received FDA 510(k) clearance on 1988-05-02, under 510(k) number K880485.

Who is the listed applicant for XENEX DENTAL ROULETTE?

The FDA 510(k) record lists G & A Industries, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XENEX DENTAL ROULETTE?

The FDA product code for XENEX DENTAL ROULETTE is EFW.

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Related Devices (Code: EFW)

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.

K130186DENTEK EASY BRUSH WITH FLUORIDEDen Tek Oral Care, Inc.K121165BEAM BRUSH/BEAM APPBeam Technologies, LLCK102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & GambleK021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLCK020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC

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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