SPIRIT
FDA 510(k) clearance K896913 · decided 1990-03-08
Clearance details
- K-number
- K896913
- Device name
- SPIRIT
- Applicant
- Ormco Corp.
- Decision
- Substantially Equivalent
- Date received
- 1989-12-11
- Decision date
- 1990-03-08
- Days to decision
- 87 days
- Clearance type
- Traditional
- Product code
- DYW
- Device class
- 2
- Regulation number
- 872.5470
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Glendora, CA, US
- Third-party review
- No
- Expedited review
- No
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| INSIGNIA (K121524) | Ormco Corp. | 2012-08-09 |
Recalls involving this device
No recalls on record reference this clearance.