Atlas FDA

EFW

49 FDA 510(k) clearances · Product code

83 daysmedian time to decision
179 days90th percentile
49clearances measured

FDA profile

Official device name
Toothbrush, Manual
Device class
Class I (low risk)
Regulation
21 CFR 872.6855
Medical specialty
Dental
Flags
GMP exempt
Adverse events (MAUDE)
2021: 120 · 2022: 327 · 2023: 99 · 2024: 87 · 2025: 71 · 2026: 51
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DENTEK EASY BRUSH WITH FLUORIDE (K130186)Den Tek Oral Care, Inc.2013-07-15
BEAM BRUSH/BEAM APP (K121165)Beam Technologies, LLC2012-06-21
SILVER CARE ANITBACTERIAL TOOTHBRUSH (K102871)Piave Spazzolificio S.P.A.2011-10-03
ORAL-B SUB-BRAND MANUAL TOOTHBRUSH (K073224)Procter & Gamble2008-02-06
ZEODYNE TOOTHBRUSH WITH AGION ANTIMICROBIAL (K021383)Agion Technologies, LLC2002-07-17
MEDORAL HYGIENIC TOOTHBRUSH WITH DENTOSAN FILAMENTS (K020776)Coronet Group North America, LLC2002-06-03
LAZERSMILE, LAZERWHITE (K000290)Biolase Technology, Inc.2000-04-14
TOOTHBRUSH WASH (K994144)Cal Huech, Inc.2000-03-02
BACTI-STOP TOOTHBRUSH CLEANER AND SANITIZER (K992435)Azo Enterprises1999-10-15
PLAQ-ATAQ-I (K980995)Ethicare1998-08-20
BUTLER ANTIBACTERIAL INTERDENTAL TOOTHBRUSH (K974761)John O. Butler Co.1998-06-16
CREST TOOTHBRUSH WITH MICROSHIELD (K973236)Procter & Gamble Co.1998-03-11
REACH ANTIBACTERIAL TOOTHBRUSH (K971589)Personal Products Co.1997-07-24
RANIR HI-TECHNOLOGY DENTAL FLOSS (K955530)Ranir/Dcp Corp.1995-12-28
BUTLER G.U.M. ANTIBACTERIAL TOOTHBRUSH (K950993)John O. Butler1995-06-02
ECO TOOTHBRUSH (K930869)Recycla-Dent, Inc.1993-05-06
FEEL FRESH TOOTHBRUSH KIT (K905090)Fresh Appeal , Ltd.1991-01-25
ROSOFSKY & ROSS MOUTHSPA ORAL CARE SYSTEM (K901994)Rosofsky & Ross, Inc.1990-07-31
ORALCHEK SUPER-SOFT BRUSH (K892264)Pfizer, Inc.1989-06-14
DOCTOR KOLYNOS TOOTHBRUSH (K882572)Whitehall Laboratories, Inc.1989-04-17
HEADS TRUE BRUSH (K890812)Mcs Trading Co.1989-03-17
IONODENT II (6 VOLTS) (K883761)U.S. Apatite Corp.1988-12-05
IONODENT (TOOTHBRUSH) (K874443)U.S. Apatite Corp.1988-07-19
XENEX DENTAL ROULETTE (K880485)G & A Industries, Inc.1988-05-02
EZ BRUSH & FLOSS (K873317)Ez Products, Ltd.1988-01-19
SOFSWAB (K871879)Plastic Engineered Products Co.1987-07-28
QUIK-BRUSH (K870414)Intl. Medication Systems, Ltd.1987-06-11
CHECK-MATE AND CHECK-MATE [+] (K871359)Veritech, Inc.1987-05-29
CARERITE INTERDENTAL BRUSHES, MODELS 3500 & 4500 (K870906)Cost Rite Health Products, Inc.1987-03-30
THE EXPERIMENTAL (K864455)Martin H. Kaufmann1987-03-18
ODONTO TOOTHBRUSH (K852691)Action Hygiene Products, Inc.1985-09-27
PLAK SMACKER (K852400)Plak Smacker Toothbrush Co.1985-07-01
ZACT DENTAL ARCH TOOTHBRUSCH (K833815)Jfc International, Inc.1984-02-10
REACH* TOOTHBRUSH (K834580)Johnson & Johnson Professionals, Inc.1984-02-10
PORTABLE TOOTHBRUSH KIT (NO SAMPLE) (K812361)Jdm Commodities1981-11-20
PORT. TOOTHBRUSH KIT W/4 G. TOOTHPASTE (K812364)Jdm Commodities1981-11-20
DISP. TOOTHBRUSH W/TOOTHPASTE ATTACHED (K812363)Jdm Commodities1981-11-20
DISP. TOOTHBRUSH W/3 G. TUBE OF TOOTHPST (K812362)Jdm Commodities1981-11-20
PY-CO-PROX TM DENTAL BRUSH (K800831)Block Drug Company, Inc.1980-05-08
TOTE-BRUSH (K800154)Anja Marketing, Inc.1980-02-05
DIJI-DENT (K781962)J&J Technologies, Inc.1978-12-20
DX TOOTHBRUSH (K781018)Lever Brothers Company, Inc.1978-06-30
TOOTHBRUSH, PEDODONTIC, #0126-0188-00 (K771183)Hoyt Laboratories1977-07-15
PERIODONTIC TOOTHBRUSH, #0126-0190-00 (K771185)Hoyt Laboratories1977-07-15
TOOTHBRUSH, ORTHODONTIC, #0126-0189-00 (K771184)Hoyt Laboratories1977-07-15
TOOTHBRUSH, REACH (K770749)Johnson & Johnson Professionals, Inc.1977-06-20
TOOTHBRUSH, PLAK-A-DENT (K770464)Smith, Ranscht, Pollock, Manos & Connor1977-04-08
DENTAL STAIN REMOVER (K761352)Concept, Inc.1977-01-03
TOOTHBRUSH (K760512)Asset Scientific & Pharmaceutical, Inc.1976-09-03

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Every clearance here is in the API, with alerts when new ones post.