ORTHODONTIC BRACES
FDA 510(k) clearance K981433 · decided 1998-06-25
Clearance details
- K-number
- K981433
- Device name
- ORTHODONTIC BRACES
- Applicant
- Midwest Orthodontic Mfg.
- Decision
- Substantially Equivalent
- Date received
- 1998-04-20
- Decision date
- 1998-06-25
- Days to decision
- 66 days
- Clearance type
- Traditional
- Product code
- DYW
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Columbus, IN, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| Carriere Motion Clear Class II (K160720) | Ortho Organizers, Inc. | 2016-11-28 |
| CompleClear Plastic Orthodontic Bracket and Wire Appliance (K150830) | Oracrew | 2016-08-26 |
| Exceed Tx (K150702) | Great Lakes Orthodontics, Ltd. | 2016-03-24 |
| COMPOSITE ORTHODONTIC BRACKETS (K140807) | Ortho Specialties | 2014-11-12 |
| INSIGNIA DIGICAST (K123118) | Ormco Corp. | 2013-03-26 |
| INSIGNIA WITH ITERO (K123416) | Ormco Corp. | 2013-03-13 |
| INSIGNIA (K121524) | Ormco Corp. | 2012-08-09 |
Recalls involving this device
No recalls on record reference this clearance.