FDA Product Code
FDA Product Code EJF — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.5410
510(k) Clearances — 103 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. | 2000-03-14 | Traditional | PDF ↗ |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | 1994-05-09 | Traditional | PDF ↗ |
| K933501 | ALASTIK | Unitek Corp. | 1994-04-28 | Traditional | PDF ↗ |
| K923372 | MEMORY WIRE | Althan, Inc. | 1994-04-22 | Traditional | PDF ↗ |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | 1994-03-23 | Traditional | PDF ↗ |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | 1994-02-04 | Traditional | PDF ↗ |
| K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. | 1994-02-02 | Traditional | PDF ↗ |
| K934881 | REFLECTIONS | Cdb Corp. | 1994-02-01 | Traditional | PDF ↗ |
| K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. | 1994-01-31 | Traditional | PDF ↗ |
| K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | 1994-01-26 | Traditional | PDF ↗ |
| K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent | 1994-01-26 | Traditional | PDF ↗ |
| K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. | 1994-01-21 | Traditional | PDF ↗ |
| K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. | 1994-01-18 | Traditional | PDF ↗ |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | 1993-10-20 | Traditional | PDF ↗ |
| K925012 | PLASTIC CHAIN | American Orthodontics | 1993-09-13 | Traditional | PDF ↗ |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. | 1993-09-13 | Traditional | PDF ↗ |
| K930452 | SOLO TIES | Zulaf, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. | 1993-07-08 | Traditional | PDF ↗ |
| K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH | 1993-05-27 | Traditional | PDF ↗ |
| K923405 | THE HERBST APPLIANCE | Ormco Corp. | 1993-05-05 | Traditional | PDF ↗ |
| K923440 | APEX DIRECT BONDED BRACKETS | Apex Orthodontics, Inc. | 1993-03-31 | Traditional | PDF ↗ |
| K923709 | MEMORY WIRE | Wire Products | 1993-02-02 | Traditional | PDF ↗ |
| K923261 | ORTHODONTIC METAL BRACKET | American Orthodontics | 1992-12-03 | Traditional | PDF ↗ |
| K923432 | GERMAN MINI DYNALOCK | Unitek Corp. | 1992-10-30 | Traditional | PDF ↗ |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Gac Intl., Inc. | 1992-09-28 | Traditional | PDF ↗ |
| K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET | Glenroe | 1992-08-27 | Traditional | PDF ↗ |
| K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corp. | 1992-07-30 | Traditional | PDF ↗ |
| K920645 | ORTHODONTIC ELASTICS BANDS | Masel Industries, Inc. | 1992-07-28 | Traditional | PDF ↗ |
| K914003 | MIDAS BRACKET | Gold'N Braces, Inc. | 1991-12-16 | Traditional | PDF ↗ |
| K913913 | REFURBISHED ORTHODONTIC APPLIANCES | Ortho-Cycle Co. | 1991-11-27 | Traditional | PDF ↗ |
| K914616 | KLEER(TM) ORTHODONTIC BRACKET | Ormco Corp. | 1991-11-20 | Traditional | PDF ↗ |
| K911231 | ORTHODONTIC WIRE | Masel Industries, Inc. | 1991-10-08 | Traditional | PDF ↗ |
| K912171 | PREDISPENSED ORTHODONTIC CERAMIC BRACKET ADHESIVE | Jack James | 1991-08-13 | Traditional | PDF ↗ |
| K910288 | NONSTAINING ALASTIKS | Unitek Corp. | 1991-03-29 | Traditional | PDF ↗ |
| K903498 | RETAINER, SCREW EXPANSION ORTHODONTIC | Masel Industries, Inc. | 1991-03-12 | Traditional | PDF ↗ |
| K902809 | BRACKET, METAL, ORTHODOTNIC | Masel Industries, Inc. | 1990-12-07 | Traditional | PDF ↗ |
| K904092 | LANCER ORIGINAL, SIERRA, GENERAL PURPOSE | Lancer Orthodontics, Inc. | 1990-11-09 | Traditional | PDF ↗ |
| K904093 | BUCCAL TUBE, BUCCAL ATTACHMENT | Lancer Orthodontics, Inc. | 1990-11-07 | Traditional | PDF ↗ |
| K904091 | TITANAL,STERLING SPRING,DUAL FLEX,MEMOREX,BENDALLO | Lancer Orthodontics, Inc. | 1990-11-05 | Traditional | PDF ↗ |
| K904094 | C.A.T.,SINTERLINE,NATURAL ARCH,MICROTWIN,BIOTORQUE | Lancer Orthodontics, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K904089 | PERMA MESH | Lancer Orthodontics, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K902844 | NICKEL-TITANIUM ORTHODONTIC TOOTH SEPARATING SPRIN | Progressive Dental Supply | 1990-09-05 | Traditional | PDF ↗ |
| K903214 | OXYGEN, AIR, VACUUM, AND NITROUS COUPLERS | Medical Fittings, Inc. | 1990-09-05 | Traditional | PDF ↗ |
| K900678 | THE MYOLOC SYSTEM | Winder Research, Inc. | 1990-08-13 | Traditional | PDF ↗ |
| K902390 | AURA CERAMIC DENTAL APPLIANCE | Progressive Technology, Inc. | 1990-08-13 | Traditional | PDF ↗ |
| K901896 | ENDOMETRIAL SAMPLER | Kirwan Surgical Products, Inc. | 1990-08-13 | Traditional | PDF ↗ |
| K902064 | MODIFIED UNI-STICK PLASTIC LIGATURE | American Orthodontics | 1990-08-06 | Traditional | PDF ↗ |
| K902050 | BIOLASTIC SUPER ELASTIC ARCHES | Rmo, Inc. | 1990-08-03 | Traditional | PDF ↗ |
| K900471 | FIBERBRAID(TM) BONDED RETAINER | Uthoff Dental Mfg. | 1990-08-02 | Traditional | PDF ↗ |
| K901957 | MUSTANG, C.A.T. | Lancer Orthodontics, Inc. | 1990-07-30 | Traditional | PDF ↗ |
| K900488 | MODIFIED X-RING AND SPEED STIX PLASTICE LIGATURE | American Orthodontics | 1990-06-01 | Traditional | PDF ↗ |
| K900824 | FLUOR-I-CHAINS(TM) AND FLUOR-I-TIES(TM) | Midwest Orthodontic Mfg. | 1990-05-22 | Traditional | PDF ↗ |
| K901024 | STAINLESS STEEL DENTAL WIRES AND CLASPS | Ivoclar North America, Inc. | 1990-04-25 | Traditional | PDF ↗ |
| K900578 | SPORTS PACK ELASTICS | Lancer Orthodontics, Inc. | 1990-04-10 | Traditional | PDF ↗ |
| K895854 | ACME PREFORMED COATED LIGATURE TIES (TOOTH SHADE) | Acme-Monaco Corp. | 1990-04-09 | Traditional | PDF ↗ |
| K900184 | LINGUAL SHEATH | Ormco Corp. | 1990-04-02 | Traditional | PDF ↗ |
| K895483 | ACME COATED ORTHODONTIC ARCHWIRE | Acme-Monaco Corp. | 1990-01-29 | Traditional | PDF ↗ |
| K891331 | UNI-STICK PLASTIC LIGATURES | American Orthodontics | 1989-10-16 | Traditional | PDF ↗ |
| K893482 | KORN MANDIBULAR ADVANCER | American Orthodontics | 1989-10-12 | Traditional | PDF ↗ |
| K894781 | OPTIFLEX | Ormco Corp. | 1989-09-15 | Traditional | PDF ↗ |
| K894358 | LUMINA ORTHODONTIC BRACKET | Ormco Corp. | 1989-09-15 | Traditional | PDF ↗ |
| K893655 | KOBAYASHI HOOK AND TWIST KOBAYASHI HOOK | American Orthodontics | 1989-08-23 | Traditional | PDF ↗ |
| K893483 | BONDABLE RETAINER AND SPACE MAINTAINER | American Orthodontics | 1989-07-14 | Traditional | PDF ↗ |
| K891982 | J1 ATTACHMENT (ORTHODONTIC APPLIANCE) | T.M.K. Dental Products | 1989-07-14 | Traditional | PDF ↗ |
| K893484 | MULTIPHASE ORTHODONTIC WIRE | American Orthodontics | 1989-07-14 | Traditional | PDF ↗ |
| K893550 | PLASTIC FORCE MODULE | American Orthodontics | 1989-07-14 | Traditional | PDF ↗ |
| K893555 | X-RING AND SPEED STIX PLASTIC LIGATURES | American Orthodontics | 1989-07-14 | Traditional | PDF ↗ |
| K893654 | MEMORY CHAIN | American Orthodontics | 1989-06-23 | Traditional | PDF ↗ |
| K893549 | X-RING SEPARATORS | American Orthodontics | 1989-06-23 | Traditional | PDF ↗ |
| K893542 | DIASTEMA CLOSING KIT | American Orthodontics | 1989-06-23 | Traditional | PDF ↗ |
| K892419 | NPG 2 BASE METAL ALLOY | Aalba Dent, Inc. | 1989-06-16 | Traditional | PDF ↗ |
| K892704 | GEM II ORTHODONTIC BRACKET | Ormco Corp. | 1989-06-12 | Traditional | PDF ↗ |
| K891775 | MANDIBULAR LIP BUMPER AND LIP BUMPER TUBES | American Orthodontics | 1989-05-11 | Traditional | PDF ↗ |
| K891599 | FILAFLEX ORTHODONTIC WIRE | American Orthodontics | 1989-05-02 | Traditional | PDF ↗ |
| K890536 | JASPER JUMPER KIT | American Orthodontics | 1989-05-01 | Traditional | PDF ↗ |
| K890656 | LIP BUMPER | American Orthodontics | 1989-04-17 | Traditional | PDF ↗ |
| K891484 | ORTHODONTIC WRAP-AROUND HAWLEY RETAINER | American Orthodontics | 1989-04-14 | Traditional | PDF ↗ |
| K891592 | ORTHODONTIC ARCH AND SURGICAL HOOKS | American Orthodontics | 1989-04-07 | Traditional | PDF ↗ |
| K890581 | THE CLARK LIP SHIELD | American Orthodontics | 1989-03-17 | Traditional | PDF ↗ |
| K890145 | 20/20 ORTHODONTIC CERAMIC BRACKET | American Orthodontics | 1989-03-13 | Traditional | PDF ↗ |
| K890529 | ALASTIGARD | Unitek Corp. | 1989-03-09 | Traditional | PDF ↗ |
| K885086 | TIN COATED NITI ORTHODONTIC ARCH WIRES | Flexmedics | 1989-01-10 | Traditional | PDF ↗ |
| K883120 | FLEX PLASTIC PLASTIC COATED NITINOL ARCH WIRE | Flexmedics | 1988-11-14 | Traditional | PDF ↗ |
| K881789 | MINILINE BRACKET | Alexotek Co. | 1988-06-01 | Traditional | PDF ↗ |
| K874396 | OCO PREPARATIONS | Williams Importing Company, Inc. | 1988-05-18 | Traditional | PDF ↗ |
| K881233 | STRAIGHT LENGTH ARCH WIRES | Flexmedics | 1988-04-12 | Traditional | PDF ↗ |
| K881274 | CENTER BEND ARCH WIRES | Flexmedics | 1988-04-12 | Traditional | PDF ↗ |
| K880882 | REVERSE CURVE ARCHWIRE | Flexmedics | 1988-04-11 | Traditional | PDF ↗ |
| K881163 | RECTANGULAR NITINOL ARCH WIRE | Flexmedics | 1988-04-07 | Traditional | PDF ↗ |
| K874226 | STANDARD EDGEWISE/ALL SYSTEMS GO/ULTRA LOW BRACKET | Advanced Orthodontics Systems, Inc. | 1987-12-29 | Traditional | PDF ↗ |
| K873649 | FLEX GOLD | Flexmedics | 1987-10-05 | Traditional | PDF ↗ |
| K870536 | GEM ORTHODONTIC BRACKET | Ormco Corp. | 1987-02-19 | Traditional | PDF ↗ |
| K852179 | CERAMIC ORTHODONIT APPLIANCE | Gac Intl., Inc. | 1985-08-20 | Traditional | PDF ↗ |
| K852800 | A-COMPANY SELF-LIGATING APPLIANCE | A Company, Inc. | 1985-07-31 | Traditional | PDF ↗ |
| K844067 | VANISH ORTHODONTIC BRACKET | A Company, Inc. | 1984-11-23 | Traditional | PDF ↗ |
| K843143 | STABILIZING RETAINER | Dental Advancements, Inc. | 1984-09-27 | Traditional | PDF ↗ |
| K834272 | ALEXOLOK BRACKET | Alexotek Co. | 1984-02-03 | Traditional | PDF ↗ |
| K812300 | LINGUAL BRACKET | American Ormco | 1981-09-21 | Traditional | PDF ↗ |
| K803316 | ORTHODONTIC BRACKET | Orec Corp. | 1981-01-14 | Traditional | PDF ↗ |
Product code EJF · Class I · Dental. Data: openFDA.