FDA 510(k)

DENTEK EASY BRUSH WITH FLUORIDE

K-Number: K130186 · 2013-07-15

Decision Date2013-07-15

Product CodeEFW

Advisory CommitteeDE

DecisionSubstantially Equivalent

Device Summary

DENTEK EASY BRUSH WITH FLUORIDE is the device name listed in this FDA 510(k) record. The listed applicant is Den Tek Oral Care, Inc.. It received FDA 510(k) clearance on 2013-07-15 under 510(k) number K130186. 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 DENTEK EASY BRUSH WITH FLUORIDE?

DENTEK EASY BRUSH WITH FLUORIDE is a medical device that received FDA 510(k) clearance on 2013-07-15. The listed applicant is Den Tek Oral Care, Inc.. The 510(k) number is K130186.

When did DENTEK EASY BRUSH WITH FLUORIDE receive FDA 510(k) clearance?

DENTEK EASY BRUSH WITH FLUORIDE received FDA 510(k) clearance on 2013-07-15, under 510(k) number K130186.

Who is the listed applicant for DENTEK EASY BRUSH WITH FLUORIDE?

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

What is the FDA product code for DENTEK EASY BRUSH WITH FLUORIDE?

The FDA product code for DENTEK EASY BRUSH WITH FLUORIDE is EFW.

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Other records listing Den Tek Oral Care, Inc. as applicant

K123849NEW COMFORT-FIT DENTAL GUARD K091660CUSTOM COMFORT NIGHTGUARD VERSION 2 K083400CUSTOM COMFORT NIGHTGUARD K081669IMPROVED COMFORT-FIT NIGHTGUARD K072147DEN TEK COMFORT FIT NIGHTGUARD K063483DEN TEK NIGHTGUARD

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Related Devices (Code: EFW)

K121165BEAM BRUSH/BEAM APPBeam Technologies, LLC K102871SILVER CARE ANITBACTERIAL TOOTHBRUSHPiave Spazzolificio S.P.A.K073224ORAL-B SUB-BRAND MANUAL TOOTHBRUSHProcter & Gamble K021383ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIALAgion Technologies, LLC K020776MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTSCoronet Group North America, LLC K000290LAZERSMILE, LAZERWHITEBiolase Technology, Inc.

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.