Product Code: EFW FDA class 1 21 CFR 872.6855

Toothbrush, Manual

Dental

The Manual Toothbrush is a dental hygiene device used by individuals to mechanically remove plaque and food debris from tooth surfaces and the gingival margin through brushing with dentifrice, helping to prevent caries and periodontal disease. It is classified as FDA Class 1, the lowest risk category, and is GMP exempt, meaning it is also exempt from most good manufacturing practice requirements. The product code is EFW and the applicable regulation is 21 CFR 872.6855, under the Dental medical specialty.

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510(k)s

FEI Numbers

573

Registration Numbers

574

Unique Applicants

Years Active

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Basic Information

Product Code: EFW
Device Class: FDA class 1
Regulation Number: 872.6855
Medical Specialty: Dental
Review Panel: DE
Submission Type: 4

Device Characteristics

✓

GMP Exempt

✗

Implant

✗

Life Sustain/Support

✗

Third Party

—

Summary Malfunction Reporting

510(k) Clearance History

Related 510(k) Clearances

This FDA classification is associated with 49 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K130186	DENTEK EASY BRUSH WITH FLUORIDE	Jul 15, 2013	Substantially Equivalent	Den Tek Oral Care, Inc.
K121165	BEAM BRUSH/BEAM APP	Jun 21, 2012	Substantially Equivalent	Beam Technologies, LLC
K102871	SILVER CARE ANITBACTERIAL TOOTHBRUSH	Oct 03, 2011	Substantially Equivalent	Piave Spazzolificio S.P.A.
K073224	ORAL-B SUB-BRAND MANUAL TOOTHBRUSH	Feb 06, 2008	Substantially Equivalent	Procter & Gamble
K021383	ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL	Jul 17, 2002	Substantially Equivalent	Agion Technologies, LLC
K020776	MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS	Jun 03, 2002	Substantially Equivalent	Coronet Group North America, LLC
K000290	LAZERSMILE, LAZERWHITE	Apr 14, 2000	Substantially Equivalent	Biolase Technology, Inc.
K994144	TOOTHBRUSH WASH	Mar 02, 2000	Substantially Equivalent	Cal Huech, Inc.
K992435	BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER	Oct 15, 1999	Substantially Equivalent	Azo Enterprises
K980995	PLAQ-ATAQ-I	Aug 20, 1998	Substantially Equivalent	Ethicare
K974761	BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH	Jun 16, 1998	Substantially Equivalent	John O. Butler Co.
K973236	CREST TOOTHBRUSH WITH MICROSHIELD	Mar 11, 1998	Substantially Equivalent	Procter & Gamble Co.
K971589	REACH ANTIBACTERIAL TOOTHBRUSH	Jul 24, 1997	Substantially Equivalent	Personal Products Co.
K955530	RANIR HI-TECHNOLOGY DENTAL FLOSS	Dec 28, 1995	Substantially Equivalent	Ranir/Dcp Corp.
K950993	BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH	Jun 02, 1995	Substantially Equivalent	John O. Butler
K930869	ECO TOOTHBRUSH	May 06, 1993	Substantially Equivalent	Recycla-Dent, Inc.
K905090	FEEL FRESH TOOTHBRUSH KIT	Jan 25, 1991	Substantially Equivalent	Fresh Appeal , Ltd.
K901994	ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM	Jul 31, 1990	Unknown	Rosofsky & Ross, Inc.
K892264	ORALCHEK SUPER-SOFT BRUSH	Jun 14, 1989	Substantially Equivalent	Pfizer, Inc.
K882572	DOCTOR KOLYNOS TOOTHBRUSH	Apr 17, 1989	Substantially Equivalent	Whitehall Laboratories, Inc.
K890812	HEADS TRUE BRUSH	Mar 17, 1989	Substantially Equivalent	Mcs Trading Co.
K883761	IONODENT II (6 VOLTS)	Dec 05, 1988	Substantially Equivalent	U.S. Apatite Corp.
K874443	IONODENT (TOOTHBRUSH)	Jul 19, 1988	Substantially Equivalent	U.S. Apatite Corp.
K880485	XENEX DENTAL ROULETTE	May 02, 1988	Substantially Equivalent	G & A Industries, Inc.
K873317	EZ BRUSH & FLOSS	Jan 19, 1988	Substantially Equivalent	Ez Products, Ltd.
K871879	SOFSWAB	Jul 28, 1987	Substantially Equivalent	Plastic Engineered Products Co.
K870414	QUIK-BRUSH	Jun 11, 1987	Substantially Equivalent	Intl. Medication Systems, Ltd.
K871359	CHECK-MATE AND CHECK-MATE [+]	May 29, 1987	Substantially Equivalent	Veritech, Inc.
K870906	CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500	Mar 30, 1987	Substantially Equivalent	Cost Rite Health Products, Inc.
K864455	THE EXPERIMENTAL	Mar 18, 1987	Substantially Equivalent for Some Indications	Martin H. Kaufmann
K852691	ODONTO TOOTHBRUSH	Sep 27, 1985	Substantially Equivalent	Action Hygiene Products, Inc.
K852400	PLAK SMACKER	Jul 01, 1985	Substantially Equivalent	Plak Smacker Toothbrush Co.
K834580	REACH* TOOTHBRUSH	Feb 10, 1984	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K833815	ZACT DENTAL ARCH TOOTHBRUSCH	Feb 10, 1984	Substantially Equivalent	Jfc International, Inc.
K812364	PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE	Nov 20, 1981	Substantially Equivalent	Jdm Commodities
K812363	DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED	Nov 20, 1981	Substantially Equivalent	Jdm Commodities
K812362	DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST	Nov 20, 1981	Substantially Equivalent	Jdm Commodities
K812361	PORTABLE TOOTHBRUSH KIT (NO SAMPLE)	Nov 20, 1981	Substantially Equivalent	Jdm Commodities
K800831	PY-CO-PROX TM DENTAL BRUSH	May 08, 1980	Substantially Equivalent	Block Drug Company, Inc.
K800154	TOTE-BRUSH	Feb 05, 1980	Substantially Equivalent	Anja Marketing, Inc.
K781962	DIJI-DENT	Dec 20, 1978	Substantially Equivalent	J&J Technologies, Inc.
K781018	DX TOOTHBRUSH	Jun 30, 1978	Substantially Equivalent	Lever Brothers Company, Inc.
K771185	PERIODONTIC TOOTHBRUSH, #0126-0190-00	Jul 15, 1977	Substantially Equivalent	Hoyt Laboratories
K771184	TOOTHBRUSH, ORTHODONTIC, #0126-0189-00	Jul 15, 1977	Substantially Equivalent	Hoyt Laboratories
K771183	TOOTHBRUSH, PEDODONTIC, #0126-0188-00	Jul 15, 1977	Substantially Equivalent	Hoyt Laboratories
K770749	TOOTHBRUSH, REACH	Jun 20, 1977	Substantially Equivalent	Johnson & Johnson Professionals, Inc.
K770464	TOOTHBRUSH, PLAK-A-DENT	Apr 08, 1977	Substantially Equivalent	Smith, Ranscht, Pollock, Manos & Connor
K761352	DENTAL STAIN REMOVER	Jan 03, 1977	Substantially Equivalent	Concept, Inc.
K760512	TOOTHBRUSH	Sep 03, 1976	Substantially Equivalent	Asset Scientific & Pharmaceutical, Inc.