PREMIER INLAY PLACER
FDA 510(k) clearance K781034 · decided 1978-06-30
Clearance details
- K-number
- K781034
- Device name
- PREMIER INLAY PLACER
- Applicant
- Premier Dental Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1978-06-19
- Decision date
- 1978-06-30
- Days to decision
- 11 days
- Clearance type
- Traditional
- Product code
- EKI
- Device class
- 1
- Regulation number
- 872.4565
- Medical specialty
- Dental
- Advisory committee
- Dental
- Location
- Mchenry, IL, 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 |
|---|---|---|
| AMALGAM CARRIER (K945220) | Buffalo Dental Mfg. Co., Inc. | 1995-01-11 |
Recalls involving this device
No recalls on record reference this clearance.