The following data is part of a premarket notification filed by Dentsply Intl. with the FDA for A Dental Amalgam Alloy (unnamed.
| Device ID | K820389 |
| 510k Number | K820389 |
| Device Name: | A DENTAL AMALGAM ALLOY (UNNAMED |
| Classification | Alloy, Amalgam |
| Applicant | DENTSPLY INTL. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-02-10 |
| Decision Date | 1982-03-11 |