FASTBRACES CERAMIC BRACKETS
FDA 510(k) clearance K130446 · decided 2013-06-07
Clearance details
- K-number
- K130446
- Device name
- FASTBRACES CERAMIC BRACKETS
- Applicant
- Orthodontic Design and Production, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-02-21
- Decision date
- 2013-06-07
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- NJM
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Vista, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.