The following data is part of a premarket notification filed by L.d. Caulk Co. with the FDA for Dental Amalgam Alloy (spherical Ii).
| Device ID | K760379 |
| 510k Number | K760379 |
| Device Name: | DENTAL AMALGAM ALLOY (SPHERICAL II) |
| Classification | Alloy, Other Noble Metal |
| Applicant | L.D. CAULK CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | EJS |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-08-05 |
| Decision Date | 1976-08-23 |