Product Code: JES FDA class 1 21 CFR 872.6390

Floss, Dental

Dental

Dental Floss is a thin thread or tape used to clean between teeth and below the gumline to remove plaque and food particles that a toothbrush cannot reach, supporting periodontal health. It is classified as FDA Class 1 (lowest risk), subject only to general controls such as proper labeling. The product code is JES, regulated under 21 CFR 872.6390, within the Dental medical specialty. No special flags apply to this device.

View on FDA

510(k)s

FEI Numbers

335

Registration Numbers

336

Unique Applicants

Years Active

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Basic Information

Product Code: JES
Device Class: FDA class 1
Regulation Number: 872.6390
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 62 510(k) clearances via K numbers.

K Number	Device Name	Decision Date	Decision	Applicant
K091964	CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS	Sep 24, 2009	Substantially Equivalent	Procter & Gamble Co.
K964976	FLOSSBRUSH WITH FLUORIDE	May 06, 1997	Substantially Equivalent	Flossbrush Interdental Cleaner and Applicator
K963746	IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID	Dec 12, 1996	Substantially Equivalent	Whitehill Oral Technologies, Inc.
K944034	PERIO-MED DENTAL FLOSS	Jul 25, 1995	Substantially Equivalent	Whitehill Oral Technologies, Inc.
K952091	VUTLER G.U.M. WITH FLUORIDE	Jun 28, 1995	Substantially Equivalent	John O. Butler Co.
K951917	JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS	May 10, 1995	Substantially Equivalent	Johnson & Johnson Consumer Products, Inc.
K944886	COLGATE PRECISION MINT WZXED DENTAL FLOSS	Apr 27, 1995	Substantially Equivalent	Colgate-Palmolive Co.
K943157	ORAL-B ULTRAFLOSS WITH FLLUORIDE	Apr 27, 1995	Substantially Equivalent	Oral-B Laboratories
K942690	RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE	Apr 27, 1995	Substantially Equivalent	Ranir/Dcp Corp.
K942689	RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE	Apr 27, 1995	Substantially Equivalent	Ranir/Dcp Corp.
K935440	JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED	Feb 03, 1994	Substantially Equivalent	Johnson & Johnson Consumer Products, Inc.
K935522	RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE	Jan 26, 1994	Substantially Equivalent	Ranir/Dcp Corp.
K931353	FLOSS PLUS	Jul 27, 1993	Substantially Equivalent	Floss Plus, Inc.
K925409	ORAL-B DENTAL FLOSS WITH FLUORIDE	Jan 28, 1993	Substantially Equivalent	Oral-B Laboratories
K925408	ORAL-B DENTAL TAPE WITH FLUORIDE	Jan 28, 1993	Substantially Equivalent	Oral-B Laboratories
K921601	ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE	Jun 16, 1992	Substantially Equivalent	Ultradent Products, Inc.
K914962	FUN FLOSS	Dec 30, 1991	Substantially Equivalent	Fun Floss Co.
K913087	DENTAL FLOSS	Sep 30, 1991	Substantially Equivalent	Westone Products , Ltd.
K912430	DENTAL FLOSS	Sep 30, 1991	Substantially Equivalent	Westone Products , Ltd.
K911701	G-FLOSS & G-FLOSS II	May 15, 1991	Substantially Equivalent	Implant Innovations International, Inc.
K911470	BUFFING FLOSS	May 15, 1991	Substantially Equivalent	Lamar Industries
K905382	SCRIBBON	Dec 17, 1990	Substantially Equivalent	Varnum Corp.
K902325	DENTAL CLEANING RINGS	Nov 13, 1990	Substantially Equivalent	H. Bernath & Assoc.
K903712	FLOSSIE TOOTHFLOSS	Sep 05, 1990	Substantially Equivalent	Flossie, Inc.
K885056	TWIXEL(TM)	Jan 04, 1989	Substantially Equivalent	Fouts Development, Inc.
K884145	FLOSER PLUS	Oct 19, 1988	Substantially Equivalent	Pacific Lin Intl., Co.
K882571	KOLYNOS DENTAL FLOSS	Oct 12, 1988	Substantially Equivalent	Whitehall Laboratories, Inc.
K883335	COLGATE DENTAL FLOSS	Aug 26, 1988	Substantially Equivalent	Colgate-Palmolive Co.
K883024	ORAL-B FLOSSERS	Aug 26, 1988	Substantially Equivalent	Oral-B Laboratories
K882828	DENTAL FLOSS PICK	Aug 12, 1988	Substantially Equivalent	Bik Pik
K882164	FLOSS CARD	Jun 10, 1988	Substantially Equivalent	Arthur Blank & Co., Inc.
K874471	SUPER FLOSSER	Jan 28, 1988	Substantially Equivalent	U.S. Pacific Corp.
K871736	CARERITE BIOPACK GINGIVAL RETRACTION CORD	May 27, 1987	Substantially Equivalent	Cost Rite Health Products, Inc.
K871393	DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE	Apr 15, 1987	Substantially Equivalent	Flossrite Corp.
K871392	DR FLOSSER REFILL	Apr 15, 1987	Substantially Equivalent	Flossrite Corp.
K870996	SEWON DENTAL FLOSSER	Mar 19, 1987	Substantially Equivalent	Sewon Industry
K864832	DENTAL FLOSS	Feb 10, 1987	Substantially Equivalent	Westone Products , Ltd.
K862694	FLOSS CARD	Aug 06, 1986	Substantially Equivalent	Floss Card Co.
K860963	'E-Z FLOSS' AND 'LAZY FLOSS'	Mar 26, 1986	Substantially Equivalent	Login Industries , Ltd.
K860769	DENTAL FLOSS HOLDER	Mar 26, 1986	Substantially Equivalent	Sewon Industry
K860324	DENTAL FLOSS CARD	Mar 26, 1986	Substantially Equivalent	Washburn Laboratories
K855113	FLOSS HOLDER (PLASTIC)	Mar 06, 1986	Substantially Equivalent	Pacific Union Dental, Inc.
K854701	RETRACT-A-CORD	Mar 06, 1986	Substantially Equivalent	Almore Intl., Inc.
K853767	FLOSPIK	Dec 02, 1985	Substantially Equivalent	Medelco , Ltd.
K844626	MINI FLOW- DENTAL FLOSS	Jan 09, 1985	Substantially Equivalent	Mini Floss
K844438	SIMPLIFLOS DENTAL FLOSSER	Jan 04, 1985	Substantially Equivalent	Valiant Steel & Equipment, Inc.
K842846	SEWON DENTAL FLOSS FOLDER	Aug 17, 1984	Substantially Equivalent	Sewon Industry
K841675	FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE	Jun 27, 1984	Substantially Equivalent	Leonard Lorch
K840093	DENTAL FLOSSING INSTRUMENT	Apr 05, 1984	Substantially Equivalent	Leverette Corp.
K831254	DENTAL FLOSS HOLDER	May 09, 1983	Substantially Equivalent	Sewon Industry
K830225	THE TOOTHPIK	Feb 18, 1983	Substantially Equivalent	Fred M. Davis
K823278	DENTAL FLOSS TIP	Nov 22, 1982	Substantially Equivalent	Sanderson Creative Products Co.
K821685	TOM'S NATURALLY WAXED FLOSSING TAPE	Aug 12, 1982	Substantially Equivalent	Tom'S of Maine, Inc.
K821155	DENTAL FLOSS HOLDER	May 24, 1982	Substantially Equivalent	Eric L. Smith
K813248	DENTAL FLOSS HOLDER	Dec 31, 1981	Substantially Equivalent	Sewon Industry
K812120	GINGI-PLAIN CORDS & BRAIDS	Sep 08, 1981	Substantially Equivalent	Belport Co., Inc.
K811926	SE WON(ALUMINUM) DENTAL FLOSS HOLDER	Jul 28, 1981	Substantially Equivalent	Sewon Industry
K811555	DENTAL FLOSS HOLDER	Jul 01, 1981	Substantially Equivalent	Sewon Industry
K803129	GO-BETWEEN	Jan 08, 1981	Substantially Equivalent	Agri Hort
K792493	GENTLE FLOSS	Dec 13, 1979	Substantially Equivalent	Paul E. Jaffe, D.M.D.
K791223	DEN-MAT DENTAL FLOSSER	Oct 09, 1979	Substantially Equivalent	Den-Mat Corp.
K760571	FLOSS-A-LOT	Sep 15, 1976	Substantially Equivalent	E. T. Skinner