AMALGAM CARRIER
FDA 510(k) clearance K945220 · decided 1995-01-11
Clearance details
- K-number
- K945220
- Device name
- AMALGAM CARRIER
- Applicant
- Buffalo Dental Mfg. Co., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1994-10-26
- Decision date
- 1995-01-11
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- EKI
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Syosset, NY, 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.
| Record | Firm | Date |
|---|---|---|
| PREMIER INLAY PLACER (K781034) | Premier Dental Products Co. | 1978-06-30 |
Recalls involving this device
No recalls on record reference this clearance.