Atlas FDA

JES

62 FDA 510(k) clearances · Product code

49 daysmedian time to decision
145 days90th percentile
62clearances measured

FDA profile

Official device name
Floss, Dental
Device class
Class I (low risk)
Regulation
21 CFR 872.6390
Medical specialty
Dental
Adverse events (MAUDE)
2016: 43 · 2017: 50 · 2018: 52 · 2019: 52 · 2020: 32 · 2021: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
CREST GLIDE CLINICAL GUM PROTECTION DENTAL FLOSS (K091964)Procter & Gamble Co.2009-09-24
FLOSSBRUSH WITH FLUORIDE (K964976)Flossbrush Interdental Cleaner and Applicator1997-05-06
IDS DENTAL FLOSS WITH SODIUM FLUORIDE MICRODENT DENTAL FLOSS WITH SODIUM FLUORIDE AP-24 DENTAL FLOSS WITH SODIUM FLUORID (K963746)Whitehill Oral Technologies, Inc.1996-12-12
PERIO-MED DENTAL FLOSS (K944034)Whitehill Oral Technologies, Inc.1995-07-25
VUTLER G.U.M. WITH FLUORIDE (K952091)John O. Butler Co.1995-06-28
JOHNSON & JOHNSON EASY SLIDE DENTAL FLOSS (K951917)Johnson & Johnson Consumer Products, Inc.1995-05-10
RANIR DENTAL FLOSS MINT WAXED WITH FLUORIDE (K942689)Ranir/Dcp Corp.1995-04-27
COLGATE PRECISION MINT WZXED DENTAL FLOSS (K944886)Colgate-Palmolive Co.1995-04-27
ORAL-B ULTRAFLOSS WITH FLLUORIDE (K943157)Oral-B Laboratories1995-04-27
RANIR DENTAL TAPE MINT WAXED WITH FLUORIDE (K942690)Ranir/Dcp Corp.1995-04-27
JOHNSON & JOHNSON FLUORIDE DENTAL FLOSS, MINT WAXED (K935440)Johnson & Johnson Consumer Products, Inc.1994-02-03
RANIR DENTAL TAPE MINT WAXED WITH FLOURIDE (K935522)Ranir/Dcp Corp.1994-01-26
FLOSS PLUS (K931353)Floss Plus, Inc.1993-07-27
ORAL-B DENTAL TAPE WITH FLUORIDE (K925408)Oral-B Laboratories1993-01-28
ORAL-B DENTAL FLOSS WITH FLUORIDE (K925409)Oral-B Laboratories1993-01-28
ULTRADENT PROD RETRACT CORD/ACCESSORY PRODUCT LINE (K921601)Ultradent Products, Inc.1992-06-16
FUN FLOSS (K914962)Fun Floss Co.1991-12-30
DENTAL FLOSS (K913087)Westone Products , Ltd.1991-09-30
DENTAL FLOSS (K912430)Westone Products , Ltd.1991-09-30
G-FLOSS & G-FLOSS II (K911701)Implant Innovations International, Inc.1991-05-15
BUFFING FLOSS (K911470)Lamar Industries1991-05-15
SCRIBBON (K905382)Varnum Corp.1990-12-17
DENTAL CLEANING RINGS (K902325)H. Bernath & Assoc.1990-11-13
FLOSSIE TOOTHFLOSS (K903712)Flossie, Inc.1990-09-05
TWIXEL(TM) (K885056)Fouts Development, Inc.1989-01-04
FLOSER PLUS (K884145)Pacific Lin Intl., Co.1988-10-19
KOLYNOS DENTAL FLOSS (K882571)Whitehall Laboratories, Inc.1988-10-12
ORAL-B FLOSSERS (K883024)Oral-B Laboratories1988-08-26
COLGATE DENTAL FLOSS (K883335)Colgate-Palmolive Co.1988-08-26
DENTAL FLOSS PICK (K882828)Bik Pik1988-08-12
FLOSS CARD (K882164)Arthur Blank & Co., Inc.1988-06-10
SUPER FLOSSER (K874471)U.S. Pacific Corp.1988-01-28
CARERITE BIOPACK GINGIVAL RETRACTION CORD (K871736)Cost Rite Health Products, Inc.1987-05-27
DR FLOSSER, FLOSSING AID/FLOSS HOLDING DEVICE (K871393)Flossrite Corp.1987-04-15
DR FLOSSER REFILL (K871392)Flossrite Corp.1987-04-15
SEWON DENTAL FLOSSER (K870996)Sewon Industry1987-03-19
DENTAL FLOSS (K864832)Westone Products , Ltd.1987-02-10
FLOSS CARD (K862694)Floss Card Co.1986-08-06
'E-Z FLOSS' AND 'LAZY FLOSS' (K860963)Login Industries , Ltd.1986-03-26
DENTAL FLOSS CARD (K860324)Washburn Laboratories1986-03-26
DENTAL FLOSS HOLDER (K860769)Sewon Industry1986-03-26
FLOSS HOLDER (PLASTIC) (K855113)Pacific Union Dental, Inc.1986-03-06
RETRACT-A-CORD (K854701)Almore Intl., Inc.1986-03-06
FLOSPIK (K853767)Medelco , Ltd.1985-12-02
MINI FLOW- DENTAL FLOSS (K844626)Mini Floss1985-01-09
SIMPLIFLOS DENTAL FLOSSER (K844438)Valiant Steel & Equipment, Inc.1985-01-04
SEWON DENTAL FLOSS FOLDER (K842846)Sewon Industry1984-08-17
FLOSS N' GLOSS/SAFETY FLOSS MED DEVICE (K841675)Leonard Lorch1984-06-27
DENTAL FLOSSING INSTRUMENT (K840093)Leverette Corp.1984-04-05
DENTAL FLOSS HOLDER (K831254)Sewon Industry1983-05-09
THE TOOTHPIK (K830225)Fred M. Davis1983-02-18
DENTAL FLOSS TIP (K823278)Sanderson Creative Products Co.1982-11-22
TOM'S NATURALLY WAXED FLOSSING TAPE (K821685)Tom'S of Maine, Inc.1982-08-12
DENTAL FLOSS HOLDER (K821155)Eric L. Smith1982-05-24
DENTAL FLOSS HOLDER (K813248)Sewon Industry1981-12-31
GINGI-PLAIN CORDS & BRAIDS (K812120)Belport Co., Inc.1981-09-08
SE WON(ALUMINUM) DENTAL FLOSS HOLDER (K811926)Sewon Industry1981-07-28
DENTAL FLOSS HOLDER (K811555)Sewon Industry1981-07-01
GO-BETWEEN (K803129)Agri Hort1981-01-08
GENTLE FLOSS (K792493)Paul E. Jaffe, D.M.D.1979-12-13
DEN-MAT DENTAL FLOSSER (K791223)Den-Mat Corp.1979-10-09
FLOSS-A-LOT (K760571)E. T. Skinner1976-09-15

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