EJF · Bracket, Metal, Orthodontic
Dental · 21 CFR 872.5410 · Class 1
Overview
| Product Code | EJF |
|---|---|
| Device Name | Bracket, Metal, Orthodontic |
| Regulation | 21 CFR 872.5410 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
An orthodontic appliance and accessories is a device intended for use in orthodontic treatment. The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Cleared Devices (103)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. | Mar 14, 2000 | SESE |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | May 9, 1994 | SESE |
| K933501 | ALASTIK | Unitek Corp. | Apr 28, 1994 | SESE |
| K923372 | MEMORY WIRE | Althan, Inc. | Apr 22, 1994 | SESE |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | Mar 23, 1994 | SESE |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | Feb 4, 1994 | SESE |
| K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. | Feb 2, 1994 | SESE |
| K934881 | REFLECTIONS | Cdb Corp. | Feb 1, 1994 | SESE |
| K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. | Jan 31, 1994 | SESE |
| K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | Jan 26, 1994 | SESE |
| K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent | Jan 26, 1994 | SESE |
| K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. | Jan 21, 1994 | SESE |
| K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. | Jan 18, 1994 | SESE |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | Oct 20, 1993 | SESE |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | Sep 13, 1993 | SESE |
| K925012 | PLASTIC CHAIN | American Orthodontics | Sep 13, 1993 | SESE |
| K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. | Sep 13, 1993 | SESE |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. | Jul 8, 1993 | SESE |
| K930452 | SOLO TIES | Zulaf, Inc. | Jul 8, 1993 | SESE |
| K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH | May 27, 1993 | SESE |
| K923405 | THE HERBST APPLIANCE | Ormco Corp. | May 5, 1993 | SESE |
| K923440 | APEX DIRECT BONDED BRACKETS | Apex Orthodontics, Inc. | Mar 31, 1993 | SESE |
| K923709 | MEMORY WIRE | Wire Products | Feb 2, 1993 | SESE |
| K923261 | ORTHODONTIC METAL BRACKET | American Orthodontics | Dec 3, 1992 | SESE |
| K923432 | GERMAN MINI DYNALOCK | Unitek Corp. | Oct 30, 1992 | SESE |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Gac Intl., Inc. | Sep 28, 1992 | SESE |
| K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET | Glenroe | Aug 27, 1992 | SESE |
| K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corp. | Jul 30, 1992 | SESE |
| K920645 | ORTHODONTIC ELASTICS BANDS | Masel Industries, Inc. | Jul 28, 1992 | SESE |
| K914003 | MIDAS BRACKET | Gold'N Braces, Inc. | Dec 16, 1991 | SESE |
| K913913 | REFURBISHED ORTHODONTIC APPLIANCES | Ortho-Cycle Co. | Nov 27, 1991 | SESE |
| K914616 | KLEER(TM) ORTHODONTIC BRACKET | Ormco Corp. | Nov 20, 1991 | SESE |
| K911231 | ORTHODONTIC WIRE | Masel Industries, Inc. | Oct 8, 1991 | SESE |
| K912171 | PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE | Jack James | Aug 13, 1991 | SESE |
| K910288 | NONSTAINING ALASTIKS | Unitek Corp. | Mar 29, 1991 | SESE |
| K903498 | RETAINER, SCREW EXPANSION ORTHODONTIC | Masel Industries, Inc. | Mar 12, 1991 | SESE |
| K902809 | BRACKET, METAL, ORTHODOTNIC | Masel Industries, Inc. | Dec 7, 1990 | SESE |
| K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE | Lancer Orthodontics, Inc. | Nov 9, 1990 | SESE |
| K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | Lancer Orthodontics, Inc. | Nov 7, 1990 | SESE |
| K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | Lancer Orthodontics, Inc. | Nov 5, 1990 | SESE |
| K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | Lancer Orthodontics, Inc. | Nov 2, 1990 | SESE |
| K904089 | PERMA MESH | Lancer Orthodontics, Inc. | Nov 2, 1990 | SESE |
| K903214 | OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS | Medical Fittings, Inc. | Sep 5, 1990 | SESE |
| K902844 | NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN | Progressive Dental Supply | Sep 5, 1990 | SESE |
| K902390 | AURA CERAMIC DENTAL APPLIANCE | Progressive Technology, Inc. | Aug 13, 1990 | SESE |
| K901896 | ENDOMETRIAL SAMPLER | Kirwan Surgical Products, Inc. | Aug 13, 1990 | SESE |
| K900678 | THE MYOLOC SYSTEM | Winder Research, Inc. | Aug 13, 1990 | SESE |
| K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE | American Orthodontics | Aug 6, 1990 | SESE |
| K902050 | BIOLASTIC SUPER ELASTIC ARCHES | Rmo, Inc. | Aug 3, 1990 | SESE |
| K900471 | FIBERBRAID(TM) BONDED RETAINER | Uthoff Dental Mfg. | Aug 2, 1990 | SESE |
| K901957 | MUSTANG, C.A.T. | Lancer Orthodontics, Inc. | Jul 30, 1990 | SESE |
| K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE | American Orthodontics | Jun 1, 1990 | SESE |
| K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | Midwest Orthodontic Mfg. | May 22, 1990 | SESE |
| K901024 | STAINLESS STEEL DENTAL WIRES AND CLASPS | Ivoclar North America, Inc. | Apr 25, 1990 | SESE |
| K900578 | SPORTS PACK ELASTICS | Lancer Orthodontics, Inc. | Apr 10, 1990 | SESE |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | Acme-Monaco Corp. | Apr 9, 1990 | SESE |
| K900184 | LINGUAL SHEATH | Ormco Corp. | Apr 2, 1990 | SESE |
| K895483 | ACME COATED ORTHODONTIC ARCHWIRE | Acme-Monaco Corp. | Jan 29, 1990 | SESE |
| K891331 | UNI-STICK PLASTIC LIGATURES | American Orthodontics | Oct 16, 1989 | SESE |
| K893482 | KORN MANDIBULAR ADVANCER | American Orthodontics | Oct 12, 1989 | SESE |
| K894781 | OPTIFLEX | Ormco Corp. | Sep 15, 1989 | SESE |
| K894358 | LUMINA ORTHODONTIC BRACKET | Ormco Corp. | Sep 15, 1989 | SESE |
| K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK | American Orthodontics | Aug 23, 1989 | SESE |
| K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES | American Orthodontics | Jul 14, 1989 | SESE |
| K893550 | PLASTIC FORCE MODULE | American Orthodontics | Jul 14, 1989 | SESE |
| K893484 | MULTIPHASE ORTHODONTIC WIRE | American Orthodontics | Jul 14, 1989 | SESE |
| K893483 | BONDABLE RETAINER AND SPACE MAINTAINER | American Orthodontics | Jul 14, 1989 | SESE |
| K891982 | J1 ATTACHMENT (ORTHODONTIC APPLIANCE) | T.M.K. Dental Products | Jul 14, 1989 | SESE |
| K893654 | MEMORY CHAIN | American Orthodontics | Jun 23, 1989 | SESE |
| K893549 | X-RING SEPARATORS | American Orthodontics | Jun 23, 1989 | SESE |
| K893542 | DIASTEMA CLOSING KIT | American Orthodontics | Jun 23, 1989 | SESE |
| K892419 | NPG 2 BASE METAL ALLOY | Aalba Dent, Inc. | Jun 16, 1989 | SESE |
| K892704 | GEM II ORTHODONTIC BRACKET | Ormco Corp. | Jun 12, 1989 | SESE |
| K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES | American Orthodontics | May 11, 1989 | SESE |
| K891599 | FILAFLEX ORTHODONTIC WIRE | American Orthodontics | May 2, 1989 | SESE |
| K890536 | JASPER JUMPER KIT | American Orthodontics | May 1, 1989 | SESE |
| K890656 | LIP BUMPER | American Orthodontics | Apr 17, 1989 | SESE |
| K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER | American Orthodontics | Apr 14, 1989 | SESE |
| K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS | American Orthodontics | Apr 7, 1989 | SESE |
| K890581 | THE CLARK LIP SHIELD | American Orthodontics | Mar 17, 1989 | SESE |
| K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET | American Orthodontics | Mar 13, 1989 | SESE |
| K890529 | ALASTIGARD | Unitek Corp. | Mar 9, 1989 | SESE |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Flexmedics | Jan 10, 1989 | SESE |
| K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | Flexmedics | Nov 14, 1988 | SESE |
| K881789 | MINILINE BRACKET | Alexotek Co. | Jun 1, 1988 | SESE |
| K874396 | OCO PREPARATIONS | Williams Importing Company, Inc. | May 18, 1988 | SESE |
| K881274 | CENTER BEND ARCH WIRES | Flexmedics | Apr 12, 1988 | SESE |
| K881233 | STRAIGHT LENGTH ARCH WIRES | Flexmedics | Apr 12, 1988 | SESE |
| K880882 | REVERSE CURVE ARCHWIRE | Flexmedics | Apr 11, 1988 | SESE |
| K881163 | RECTANGULAR NITINOL ARCH WIRE | Flexmedics | Apr 7, 1988 | SESE |
| K874226 | STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET | Advanced Orthodontics Systems, Inc. | Dec 29, 1987 | SESE |
| K873649 | FLEX GOLD | Flexmedics | Oct 5, 1987 | SESE |
| K870536 | GEM ORTHODONTIC BRACKET | Ormco Corp. | Feb 19, 1987 | SESE |
| K852179 | CERAMIC ORTHODONIT APPLIANCE | Gac Intl., Inc. | Aug 20, 1985 | SESE |
| K852800 | A-COMPANY SELF-LIGATING APPLIANCE | A Company, Inc. | Jul 31, 1985 | SESE |
| K844067 | VANISH ORTHODONTIC BRACKET | A Company, Inc. | Nov 23, 1984 | SESE |
| K843143 | STABILIZING RETAINER | Dental Advancements, Inc. | Sep 27, 1984 | SESE |
| K834272 | ALEXOLOK BRACKET | Alexotek Co. | Feb 3, 1984 | SESE |
| K812300 | LINGUAL BRACKET | American Ormco | Sep 21, 1981 | SESE |
| K803316 | ORTHODONTIC BRACKET | Orec Corp. | Jan 14, 1981 | SESE |
| K801809 | ORTHODONTIC BRACKET/SPEED/HANSON SPEED | Strite Industries , Ltd. | Aug 13, 1980 | SESE |
| K780170 | ORTHODONTIC BRACKET PADS | Rocky Mountain Orthodontics, Inc. | Mar 15, 1978 | SESE |
| K771774 | NEW BASE FOR ORTHODONTIC APPLIANCES | Gac Intl., Inc. | Sep 30, 1977 | SESE |
Top Applicants
- American Orthodontics — 22 clearances
- Ormco Corp. — 8 clearances
- Lancer Orthodontics, Inc. — 7 clearances
- Flexmedics — 7 clearances
- Gac Intl., Inc. — 5 clearances
