The following data is part of a premarket notification filed by Lloyd Baum Center, Inc. with the FDA for E-z Gold Tooth Filling Material.
| Device ID | K915507 |
| 510k Number | K915507 |
| Device Name: | E-Z GOLD TOOTH FILLING MATERIAL |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | LLOYD BAUM CENTER, INC. 25742 HINCKLEY ST. Loma Linda, CA 92354 |
| Contact | Lloyd Baum |
| Correspondent | Lloyd Baum LLOYD BAUM CENTER, INC. 25742 HINCKLEY ST. Loma Linda, CA 92354 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-12-09 |
| Decision Date | 1992-05-05 |