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FDA 510(k)

ODONTO TOOTHBRUSH

K-Number: K852691 · 1985-09-27

ApplicantAction Hygiene Products, Inc.
Decision Date1985-09-27
Product CodeEFW
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ODONTO TOOTHBRUSH is the device name listed in this FDA 510(k) record. The listed applicant is Action Hygiene Products, Inc.. It received FDA 510(k) clearance on 1985-09-27 under 510(k) number K852691. 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 ODONTO TOOTHBRUSH?

ODONTO TOOTHBRUSH is a medical device that received FDA 510(k) clearance on 1985-09-27. The listed applicant is Action Hygiene Products, Inc.. The 510(k) number is K852691.

When did ODONTO TOOTHBRUSH receive FDA 510(k) clearance?

ODONTO TOOTHBRUSH received FDA 510(k) clearance on 1985-09-27, under 510(k) number K852691.

Who is the listed applicant for ODONTO TOOTHBRUSH?

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

What is the FDA product code for ODONTO TOOTHBRUSH?

The FDA product code for ODONTO TOOTHBRUSH 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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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