510(k) K771749
- Device
- AMALGAM DISPENSER
- Applicant
- New Dimensions IN Medicine, Inc.
- 510(k) number
- K771749
- Product code
- EHE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-09-28
- Date received
- 1977-09-15
- Regulation
- 872.3080
- Classification name
- Dispenser, Mercury And/Or Alloy
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3009171220
- 2411797
- 1450653
- 2182762
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code EHE#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K771396 | DISPENSER, MERCURY & TABLET/POWDER | Johnson & Johnson Professionals, Inc. | 1977-08-03 |