Bracket, Metal, Orthodontic
Regulation 872.5410
0510(k)s in 12 months (103 all time)
0recalls in 12 months (8 all time)
1recalls that name a 510(k)
Top companies in EJF
| Company | 510(k)s | Recalls |
|---|---|---|
| American Orthodontics | 22 | 0 |
| Ormco Corp. | 8 | 2 |
| Flexmedics | 7 | 0 |
| Lancer Orthodontics, Inc. | 7 | 0 |
| Gac Intl., Inc. | 5 | 0 |
| Masel Industries, Inc. | 4 | 0 |
| Ortho Organizers, Inc. | 2 | 2 |
| Unitek Corp. | 4 | 0 |
| Ormco/Sybronendo | 0 | 3 |
| A Company, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 30, 1990 | K901957 | MUSTANG, C.A.T. Lancer Orthodontics, Inc. | EJF |
| Jun 1, 1990 | K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE American Orthodontics | EJF |
| May 22, 1990 | K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) Midwest Orthodontic Mfg. | EJF |
| Apr 25, 1990 | K901024 | STAINLESS STEEL DENTAL WIRES AND CLASPS Ivoclar North America, Inc. | EJF |
| Apr 10, 1990 | K900578 | SPORTS PACK ELASTICS Lancer Orthodontics, Inc. | EJF |
| Apr 9, 1990 | K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) Acme-Monaco Corp. | EJF |
| Apr 2, 1990 | K900184 | LINGUAL SHEATH Ormco Corp. | EJF |
| Jan 29, 1990 | K895483 | ACME COATED ORTHODONTIC ARCHWIRE Acme-Monaco Corp. | EJF |
| Oct 16, 1989 | K891331 | UNI-STICK PLASTIC LIGATURES American Orthodontics | EJF |
| Oct 12, 1989 | K893482 | KORN MANDIBULAR ADVANCER American Orthodontics | EJF |
| Sep 15, 1989 | K894781 | OPTIFLEX Ormco Corp. | EJF |
| Sep 15, 1989 | K894358 | LUMINA ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Aug 23, 1989 | K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK American Orthodontics | EJF |
| Jul 14, 1989 | K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES American Orthodontics | EJF |
| Jul 14, 1989 | K893550 | PLASTIC FORCE MODULE American Orthodontics | EJF |
| Jul 14, 1989 | K893484 | MULTIPHASE ORTHODONTIC WIRE American Orthodontics | EJF |
| Jul 14, 1989 | K893483 | BONDABLE RETAINER AND SPACE MAINTAINER American Orthodontics | EJF |
| Jul 14, 1989 | K891982 | J1 ATTACHMENT (ORTHODONTIC APPLIANCE) T.M.K. Dental Products | EJF |
| Jun 23, 1989 | K893654 | MEMORY CHAIN American Orthodontics | EJF |
| Jun 23, 1989 | K893549 | X-RING SEPARATORS American Orthodontics | EJF |
| Jun 23, 1989 | K893542 | DIASTEMA CLOSING KIT American Orthodontics | EJF |
| Jun 16, 1989 | K892419 | NPG 2 BASE METAL ALLOY Aalba Dent, Inc. | EJF |
| Jun 12, 1989 | K892704 | GEM II ORTHODONTIC BRACKET Ormco Corp. | EJF |
| May 11, 1989 | K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES American Orthodontics | EJF |
| May 2, 1989 | K891599 | FILAFLEX ORTHODONTIC WIRE American Orthodontics | EJF |
| May 1, 1989 | K890536 | JASPER JUMPER KIT American Orthodontics | EJF |
| Apr 17, 1989 | K890656 | LIP BUMPER American Orthodontics | EJF |
| Apr 14, 1989 | K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER American Orthodontics | EJF |
| Apr 7, 1989 | K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS American Orthodontics | EJF |
| Mar 17, 1989 | K890581 | THE CLARK LIP SHIELD American Orthodontics | EJF |
| Mar 13, 1989 | K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET American Orthodontics | EJF |
| Mar 9, 1989 | K890529 | ALASTIGARD Unitek Corp. | EJF |
| Jan 10, 1989 | K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES Flexmedics | EJF |
| Nov 14, 1988 | K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE Flexmedics | EJF |
| Jun 1, 1988 | K881789 | MINILINE BRACKET Alexotek Co. | EJF |
| May 18, 1988 | K874396 | OCO PREPARATIONS Williams Importing Company, Inc. | EJF |
| Apr 12, 1988 | K881274 | CENTER BEND ARCH WIRES Flexmedics | EJF |
| Apr 12, 1988 | K881233 | STRAIGHT LENGTH ARCH WIRES Flexmedics | EJF |
| Apr 11, 1988 | K880882 | REVERSE CURVE ARCHWIRE Flexmedics | EJF |
| Apr 7, 1988 | K881163 | RECTANGULAR NITINOL ARCH WIRE Flexmedics | EJF |
| Dec 29, 1987 | K874226 | STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET Advanced Orthodontics Systems, Inc. | EJF |
| Oct 5, 1987 | K873649 | FLEX GOLD Flexmedics | EJF |
| Feb 19, 1987 | K870536 | GEM ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Aug 20, 1985 | K852179 | CERAMIC ORTHODONIT APPLIANCE Gac Intl., Inc. | EJF |
| Jul 31, 1985 | K852800 | A-COMPANY SELF-LIGATING APPLIANCE A Company, Inc. | EJF |
| Nov 23, 1984 | K844067 | VANISH ORTHODONTIC BRACKET A Company, Inc. | EJF |
| Sep 27, 1984 | K843143 | STABILIZING RETAINER Dental Advancements, Inc. | EJF |
| Feb 3, 1984 | K834272 | ALEXOLOK BRACKET Alexotek Co. | EJF |
| Sep 21, 1981 | K812300 | LINGUAL BRACKET American Ormco | EJF |
| Jan 14, 1981 | K803316 | ORTHODONTIC BRACKET Orec Corp. | EJF |
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