AMALGAM DISPENSER
FDA 510(k) clearance K771749 · decided 1977-09-28
Clearance details
- K-number
- K771749
- Device name
- AMALGAM DISPENSER
- Applicant
- New Dimensions IN Medicine, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-09-15
- Decision date
- 1977-09-28
- Days to decision
- 13 days
- Clearance type
- Traditional
- Product code
- EHE
- Device class
- 1
- Regulation number
- 872.3080
- 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 |
|---|---|---|
| DISPENSER, MERCURY & TABLET/POWDER (K771396) | Johnson & Johnson Professionals, Inc. | 1977-08-03 |
Recalls involving this device
No recalls on record reference this clearance.