QAR HANDPIECE
FDA 510(k) clearance K904671 · decided 1990-12-21
Clearance details
- K-number
- K904671
- Device name
- QAR HANDPIECE
- Applicant
- Collagen Corp.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-12
- Decision date
- 1990-12-21
- Days to decision
- 70 days
- Clearance type
- Traditional
- Product code
- EFB
- Device class
- 1
- Regulation number
- 872.4200
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Palo Alto, CA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| ALVEOFORM TM BIOGRAFT (P860012/S005) | Collagen Corp. | 1995-03-21 |
| ALVEOFORM TM BIOGRAFT (P860012/S004) | Collagen Corp. | 1990-09-12 |
| ALVEOFORM TM BIOGRAFT (P860012/S002) | Collagen Corp. | 1990-07-17 |
| ALVEOFORM TM BIOGRAFT (P860012/S003) | Collagen Corp. | 1990-07-06 |
| ALVEOFORM TM BIOGRAFT (P860012/S001) | Collagen Corp. | 1988-12-13 |
| ALVEOFORM TM BIOGRAFT (P860012) | Collagen Corp. | 1988-10-28 |