Product code EJF
- Device name
- Bracket, Metal, Orthodontic
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.5410
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K994357 | BITEM LOCK, MODELS SW006, SW012 | Thermoelastic Technologies, Inc. | 2000-03-14 |
| K932825 | MICROARCH GOLD BRACKET | Gac Intl., Inc. | 1994-05-09 |
| K933501 | ALASTIK | Unitek Corp. | 1994-04-28 |
| K923372 | MEMORY WIRE | Althan, Inc. | 1994-04-22 |
| K933080 | ORTHOTECH DURA-GOLD BARCKETS | Orthotech | 1994-03-23 |
| K935139 | FASCINATION CERAMIC BRACKET | Dentauraum, Inc. | 1994-02-04 |
| K936244 | REGENCY BRACKET | Mid-American Dental Specialties, Inc. | 1994-02-02 |
| K934881 | REFLECTIONS | Cdb Corp. | 1994-02-01 |
| K935122 | DENTAURUM METAL BRACKETS | Dentauraum, Inc. | 1994-01-31 |
| K925028 | FORESTADENT ORTHODONTIC BANDS | Forestadent | 1994-01-26 |
| K926427 | LARIAT PALATE EXPANDER | Easy Access Orthodontics, Inc. | 1994-01-26 |
| K930881 | CHANNEL-EDGE BRACKET SYSTEM | Dualtek, Inc. | 1994-01-21 |
| K933758 | REGENCY PLUS BRACKET | Mid-American Dental Specialties, Inc. | 1994-01-18 |
| K922806 | ORMCO SPORTSGUARD | Ormco Corp. | 1993-10-20 |
| K923218 | NITANIUM PALATAL EXPANDER | Ortho Organizers, Inc. | 1993-09-13 |
| K925012 | PLASTIC CHAIN | American Orthodontics | 1993-09-13 |
| K932025 | ION-IMPLANTED NEO SENTALLOY | Gac Intl., Inc. | 1993-09-13 |
| K930452 | SOLO TIES | Zulaf, Inc. | 1993-07-08 |
| K931663 | NITANIUM PRO FORM ARCHWIRES,ROUND,SQUARE,RECTANGUL | Ortho Organizers, Inc. | 1993-07-08 |
| K924971 | FORESTADENT BRACKETS | Forestadent Bernhard Forster GmbH | 1993-05-27 |
| K923405 | THE HERBST APPLIANCE | Ormco Corp. | 1993-05-05 |
| K923440 | APEX DIRECT BONDED BRACKETS | Apex Orthodontics, Inc. | 1993-03-31 |
| K923709 | MEMORY WIRE | Wire Products | 1993-02-02 |
| K923261 | ORTHODONTIC METAL BRACKET | American Orthodontics | 1992-12-03 |
| K923432 | GERMAN MINI DYNALOCK | Unitek Corp. | 1992-10-30 |
| K923029 | ORTHODONTIC STAINLESS STEEL BRACKET | Gac Intl., Inc. | 1992-09-28 |
| K923124 | GLENROE GOLDEN ORTHODONTIC BRACKET | Glenroe | 1992-08-27 |
| K922499 | REFLECTIONS - CERAMIC DENTAL BRACKET | Cdb Corp. | 1992-07-30 |
| K920645 | ORTHODONTIC ELASTICS BANDS | Masel Industries, Inc. | 1992-07-28 |
| K914003 | MIDAS BRACKET | Gold'N Braces, Inc. | 1991-12-16 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07895742274023 | Morelli | Dental Morelli Ltda | 2024-12-09 |
| 07895742274030 | Morelli | Dental Morelli Ltda | 2024-12-09 |
| 07895742280901 | Morelli | Dental Morelli Ltda | 2024-03-26 |
| 07895742202088 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242695 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202095 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202101 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202118 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202125 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242596 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242602 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242619 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242657 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242664 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242671 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742242688 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742259426 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202071 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202064 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202057 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202040 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202033 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202026 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202019 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742202002 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742201999 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742201982 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742201975 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742197810 | Morelli | Dental Morelli Ltda | 2021-04-30 |
| 07895742166069 | Morelli | Dental Morelli Ltda | 2021-04-30 |