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 |
|---|---|---|---|
| Mar 14, 2000 | K994357 | BITEM LOCK, MODELS SW006, SW012 Thermoelastic Technologies, Inc. | EJF |
| May 9, 1994 | K932825 | MICROARCH GOLD BRACKET Gac Intl., Inc. | EJF |
| Apr 28, 1994 | K933501 | ALASTIK Unitek Corp. | EJF |
| Apr 22, 1994 | K923372 | MEMORY WIRE Althan, Inc. | EJF |
| Mar 23, 1994 | K933080 | ORTHOTECH DURA-GOLD BARCKETS Orthotech | EJF |
| Feb 4, 1994 | K935139 | FASCINATION CERAMIC BRACKET Dentauraum, Inc. | EJF |
| Feb 2, 1994 | K936244 | REGENCY BRACKET Mid-American Dental Specialties, Inc. | EJF |
| Feb 1, 1994 | K934881 | REFLECTIONS Cdb Corp. | EJF |
| Jan 31, 1994 | K935122 | DENTAURUM METAL BRACKETS Dentauraum, Inc. | EJF |
| Jan 26, 1994 | K926427 | LARIAT PALATE EXPANDER Easy Access Orthodontics, Inc. | EJF |
| Jan 26, 1994 | K925028 | FORESTADENT ORTHODONTIC BANDS Forestadent, DE | EJF |
| Jan 21, 1994 | K930881 | CHANNEL-EDGE BRACKET SYSTEM Dualtek, Inc. | EJF |
| Jan 18, 1994 | K933758 | REGENCY PLUS BRACKET Mid-American Dental Specialties, Inc. | EJF |
| Oct 20, 1993 | K922806 | ORMCO SPORTSGUARD Ormco Corp. | EJF |
| Sep 13, 1993 | K932025 | ION-IMPLANTED NEO SENTALLOY Gac Intl., Inc. | EJF |
| Sep 13, 1993 | K925012 | PLASTIC CHAIN American Orthodontics | EJF |
| Sep 13, 1993 | K923218 | NITANIUM PALATAL EXPANDER Ortho Organizers, Inc. | EJF |
| Jul 8, 1993 | K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL Ortho Organizers, Inc. | EJF |
| Jul 8, 1993 | K930452 | SOLO TIES Zulaf, Inc. | EJF |
| May 27, 1993 | K924971 | FORESTADENT BRACKETS Forestadent Bernhard Forster GmbH, GR | EJF |
| May 5, 1993 | K923405 | THE HERBST APPLIANCE Ormco Corp. | EJF |
| Mar 31, 1993 | K923440 | APEX DIRECT BONDED BRACKETS Apex Orthodontics, Inc. | EJF |
| Feb 2, 1993 | K923709 | MEMORY WIRE Wire Products | EJF |
| Dec 3, 1992 | K923261 | ORTHODONTIC METAL BRACKET American Orthodontics | EJF |
| Oct 30, 1992 | K923432 | GERMAN MINI DYNALOCK Unitek Corp. | EJF |
| Sep 28, 1992 | K923029 | ORTHODONTIC STAINLESS STEEL BRACKET Gac Intl., Inc. | EJF |
| Aug 27, 1992 | K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET Glenroe | EJF |
| Jul 30, 1992 | K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET Cdb Corp. | EJF |
| Jul 28, 1992 | K920645 | ORTHODONTIC ELASTICS BANDS Masel Industries, Inc. | EJF |
| Dec 16, 1991 | K914003 | MIDAS BRACKET Gold'N Braces, Inc. | EJF |
| Nov 27, 1991 | K913913 | REFURBISHED ORTHODONTIC APPLIANCES Ortho-Cycle Co. | EJF |
| Nov 20, 1991 | K914616 | KLEER(TM) ORTHODONTIC BRACKET Ormco Corp. | EJF |
| Oct 8, 1991 | K911231 | ORTHODONTIC WIRE Masel Industries, Inc. | EJF |
| Aug 13, 1991 | K912171 | PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE Jack James | EJF |
| Mar 29, 1991 | K910288 | NONSTAINING ALASTIKS Unitek Corp. | EJF |
| Mar 12, 1991 | K903498 | RETAINER, SCREW EXPANSION ORTHODONTIC Masel Industries, Inc. | EJF |
| Dec 7, 1990 | K902809 | BRACKET, METAL, ORTHODOTNIC Masel Industries, Inc. | EJF |
| Nov 9, 1990 | K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE Lancer Orthodontics, Inc. | EJF |
| Nov 7, 1990 | K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT Lancer Orthodontics, Inc. | EJF |
| Nov 5, 1990 | K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO Lancer Orthodontics, Inc. | EJF |
| Nov 2, 1990 | K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE Lancer Orthodontics, Inc. | EJF |
| Nov 2, 1990 | K904089 | PERMA MESH Lancer Orthodontics, Inc. | EJF |
| Sep 5, 1990 | K903214 | OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS Medical Fittings, Inc. | EJF |
| Sep 5, 1990 | K902844 | NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN Progressive Dental Supply | EJF |
| Aug 13, 1990 | K902390 | AURA CERAMIC DENTAL APPLIANCE Progressive Technology, Inc. | EJF |
| Aug 13, 1990 | K901896 | ENDOMETRIAL SAMPLER Kirwan Surgical Products, Inc. | EJF |
| Aug 13, 1990 | K900678 | THE MYOLOC SYSTEM Winder Research, Inc. | EJF |
| Aug 6, 1990 | K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE American Orthodontics | EJF |
| Aug 3, 1990 | K902050 | BIOLASTIC SUPER ELASTIC ARCHES Rmo, Inc. | EJF |
| Aug 2, 1990 | K900471 | FIBERBRAID(TM) BONDED RETAINER Uthoff Dental Mfg. | EJF |
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