Atlas FDA

EJF

103 FDA 510(k) clearances · Product code

75 daysmedian time to decision
273 days90th percentile
103clearances measured

FDA profile

Official device name
Bracket, Metal, Orthodontic
Device class
Class I (low risk)
Regulation
21 CFR 872.5410
Medical specialty
Dental
Adverse events (MAUDE)
2010: 18 · 2011: 12 · 2012: 5 · 2013: 7 · 2014: 8 · 2015: 9
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free

RecordFirmDate
BITEM LOCK, MODELS SW006, SW012 (K994357)Thermoelastic Technologies, Inc.2000-03-14
MICROARCH GOLD BRACKET (K932825)Gac Intl., Inc.1994-05-09
ALASTIK (K933501)Unitek Corp.1994-04-28
MEMORY WIRE (K923372)Althan, Inc.1994-04-22
ORTHOTECH DURA-GOLD BARCKETS (K933080)Orthotech1994-03-23
FASCINATION CERAMIC BRACKET (K935139)Dentauraum, Inc.1994-02-04
REGENCY BRACKET (K936244)Mid-American Dental Specialties, Inc.1994-02-02
REFLECTIONS (K934881)Cdb Corp.1994-02-01
DENTAURUM METAL BRACKETS (K935122)Dentauraum, Inc.1994-01-31
FORESTADENT ORTHODONTIC BANDS (K925028)Forestadent1994-01-26
LARIAT PALATE EXPANDER (K926427)Easy Access Orthodontics, Inc.1994-01-26
CHANNEL-EDGE BRACKET SYSTEM (K930881)Dualtek, Inc.1994-01-21
REGENCY PLUS BRACKET (K933758)Mid-American Dental Specialties, Inc.1994-01-18
ORMCO SPORTSGUARD (K922806)Ormco Corp.1993-10-20
PLASTIC CHAIN (K925012)American Orthodontics1993-09-13
ION-IMPLANTED NEO SENTALLOY (K932025)Gac Intl., Inc.1993-09-13
NITANIUM PALATAL EXPANDER (K923218)Ortho Organizers, Inc.1993-09-13
NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL (K931663)Ortho Organizers, Inc.1993-07-08
SOLO TIES (K930452)Zulaf, Inc.1993-07-08
FORESTADENT BRACKETS (K924971)Forestadent Bernhard Forster GmbH1993-05-27
THE HERBST APPLIANCE (K923405)Ormco Corp.1993-05-05
APEX DIRECT BONDED BRACKETS (K923440)Apex Orthodontics, Inc.1993-03-31
MEMORY WIRE (K923709)Wire Products1993-02-02
ORTHODONTIC METAL BRACKET (K923261)American Orthodontics1992-12-03
GERMAN MINI DYNALOCK (K923432)Unitek Corp.1992-10-30
ORTHODONTIC STAINLESS STEEL BRACKET (K923029)Gac Intl., Inc.1992-09-28
GLENROE GOLDEN ORTHODONTIC BRACKET (K923124)Glenroe1992-08-27
REFLECTIONS - CERAMIC DENTAL BRACKET (K922499)Cdb Corp.1992-07-30
ORTHODONTIC ELASTICS BANDS (K920645)Masel Industries, Inc.1992-07-28
MIDAS BRACKET (K914003)Gold'N Braces, Inc.1991-12-16
REFURBISHED ORTHODONTIC APPLIANCES (K913913)Ortho-Cycle Co.1991-11-27
KLEER(TM) ORTHODONTIC BRACKET (K914616)Ormco Corp.1991-11-20
ORTHODONTIC WIRE (K911231)Masel Industries, Inc.1991-10-08
PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE (K912171)Jack James1991-08-13
NONSTAINING ALASTIKS (K910288)Unitek Corp.1991-03-29
RETAINER, SCREW EXPANSION ORTHODONTIC (K903498)Masel Industries, Inc.1991-03-12
BRACKET, METAL, ORTHODOTNIC (K902809)Masel Industries, Inc.1990-12-07
LANCER ORIGINAL, SIERRA, GENERAL PURPOSE (K904092)Lancer Orthodontics, Inc.1990-11-09
BUCCAL TUBE, BUCCAL ATTACHMENT (K904093)Lancer Orthodontics, Inc.1990-11-07
TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO (K904091)Lancer Orthodontics, Inc.1990-11-05
PERMA MESH (K904089)Lancer Orthodontics, Inc.1990-11-02
C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE (K904094)Lancer Orthodontics, Inc.1990-11-02
OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS (K903214)Medical Fittings, Inc.1990-09-05
NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN (K902844)Progressive Dental Supply1990-09-05
AURA CERAMIC DENTAL APPLIANCE (K902390)Progressive Technology, Inc.1990-08-13
THE MYOLOC SYSTEM (K900678)Winder Research, Inc.1990-08-13
ENDOMETRIAL SAMPLER (K901896)Kirwan Surgical Products, Inc.1990-08-13
MODIFIED UNI-STICK PLASTIC LIGATURE (K902064)American Orthodontics1990-08-06
BIOLASTIC SUPER ELASTIC ARCHES (K902050)Rmo, Inc.1990-08-03
FIBERBRAID(TM) BONDED RETAINER (K900471)Uthoff Dental Mfg.1990-08-02
MUSTANG, C.A.T. (K901957)Lancer Orthodontics, Inc.1990-07-30
MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE (K900488)American Orthodontics1990-06-01
FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) (K900824)Midwest Orthodontic Mfg.1990-05-22
STAINLESS STEEL DENTAL WIRES AND CLASPS (K901024)Ivoclar North America, Inc.1990-04-25
SPORTS PACK ELASTICS (K900578)Lancer Orthodontics, Inc.1990-04-10
ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) (K895854)Acme-Monaco Corp.1990-04-09
LINGUAL SHEATH (K900184)Ormco Corp.1990-04-02
ACME COATED ORTHODONTIC ARCHWIRE (K895483)Acme-Monaco Corp.1990-01-29
UNI-STICK PLASTIC LIGATURES (K891331)American Orthodontics1989-10-16
KORN MANDIBULAR ADVANCER (K893482)American Orthodontics1989-10-12
OPTIFLEX (K894781)Ormco Corp.1989-09-15
LUMINA ORTHODONTIC BRACKET (K894358)Ormco Corp.1989-09-15
KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK (K893655)American Orthodontics1989-08-23
J1 ATTACHMENT (ORTHODONTIC APPLIANCE) (K891982)T.M.K. Dental Products1989-07-14
X-RING AND SPEED STIX PLASTIC LIGATURES (K893555)American Orthodontics1989-07-14
BONDABLE RETAINER AND SPACE MAINTAINER (K893483)American Orthodontics1989-07-14
MULTIPHASE ORTHODONTIC WIRE (K893484)American Orthodontics1989-07-14
PLASTIC FORCE MODULE (K893550)American Orthodontics1989-07-14
MEMORY CHAIN (K893654)American Orthodontics1989-06-23
DIASTEMA CLOSING KIT (K893542)American Orthodontics1989-06-23
X-RING SEPARATORS (K893549)American Orthodontics1989-06-23
NPG 2 BASE METAL ALLOY (K892419)Aalba Dent, Inc.1989-06-16
GEM II ORTHODONTIC BRACKET (K892704)Ormco Corp.1989-06-12
MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES (K891775)American Orthodontics1989-05-11
FILAFLEX ORTHODONTIC WIRE (K891599)American Orthodontics1989-05-02
JASPER JUMPER KIT (K890536)American Orthodontics1989-05-01
LIP BUMPER (K890656)American Orthodontics1989-04-17
ORTHODONTIC WRAP-AROUND HAWLEY RETAINER (K891484)American Orthodontics1989-04-14
ORTHODONTIC ARCH AND SURGICAL HOOKS (K891592)American Orthodontics1989-04-07
THE CLARK LIP SHIELD (K890581)American Orthodontics1989-03-17
20/20 ORTHODONTIC CERAMIC BRACKET (K890145)American Orthodontics1989-03-13
ALASTIGARD (K890529)Unitek Corp.1989-03-09
TIN COATED NITI ORTHODONTIC ARCH WIRES (K885086)Flexmedics1989-01-10
FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE (K883120)Flexmedics1988-11-14
MINILINE BRACKET (K881789)Alexotek Co.1988-06-01
OCO PREPARATIONS (K874396)Williams Importing Company, Inc.1988-05-18
STRAIGHT LENGTH ARCH WIRES (K881233)Flexmedics1988-04-12
CENTER BEND ARCH WIRES (K881274)Flexmedics1988-04-12
REVERSE CURVE ARCHWIRE (K880882)Flexmedics1988-04-11
RECTANGULAR NITINOL ARCH WIRE (K881163)Flexmedics1988-04-07
STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET (K874226)Advanced Orthodontics Systems, Inc.1987-12-29
FLEX GOLD (K873649)Flexmedics1987-10-05
GEM ORTHODONTIC BRACKET (K870536)Ormco Corp.1987-02-19
CERAMIC ORTHODONIT APPLIANCE (K852179)Gac Intl., Inc.1985-08-20
A-COMPANY SELF-LIGATING APPLIANCE (K852800)A Company, Inc.1985-07-31
VANISH ORTHODONTIC BRACKET (K844067)A Company, Inc.1984-11-23
STABILIZING RETAINER (K843143)Dental Advancements, Inc.1984-09-27
ALEXOLOK BRACKET (K834272)Alexotek Co.1984-02-03
LINGUAL BRACKET (K812300)American Ormco1981-09-21
ORTHODONTIC BRACKET (K803316)Orec Corp.1981-01-14
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