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FDA 510(k)

ORALCHEK SUPER-SOFT BRUSH

K-Number: K892264 · 1989-06-14

ApplicantPfizer, Inc.
Decision Date1989-06-14
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ORALCHEK SUPER-SOFT BRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Pfizer, Inc.. It received FDA 510(k) clearance on 1989-06-14 under 510(k) number K892264. 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 ORALCHEK SUPER-SOFT BRUSH?

ORALCHEK SUPER-SOFT BRUSH is a medical device that received FDA 510(k) clearance on 1989-06-14. The listed applicant is Pfizer, Inc.. The 510(k) number is K892264.

When did ORALCHEK SUPER-SOFT BRUSH receive FDA 510(k) clearance?

ORALCHEK SUPER-SOFT BRUSH received FDA 510(k) clearance on 1989-06-14, under 510(k) number K892264.

Who is the listed applicant for ORALCHEK SUPER-SOFT BRUSH?

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

What is the FDA product code for ORALCHEK SUPER-SOFT BRUSH?

The FDA product code for ORALCHEK SUPER-SOFT BRUSH 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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