TEFGEN-FD
FDA 510(k) clearance K935137 · decided 1994-08-15
Clearance details
- K-number
- K935137
- Device name
- TEFGEN-FD
- Applicant
- American Custom Medical, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-10-28
- Decision date
- 1994-08-15
- Days to decision
- 291 days
- Clearance type
- Traditional
- Product code
- NPK
- Device class
- 2
- Regulation number
- 872.3930
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Lubbock, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| TefGen is an implant material which is intended to be used as a temporary space-making bar recall (Z-1073-04) | Lifecore Biomedical, Inc. | 2004-07-20 |