The following data is part of a premarket notification filed by Precious Chemicals U.s.a., Inc. with the FDA for Gallor Dental Material & Coping Intracast Technolo.
| Device ID | K932243 |
| 510k Number | K932243 |
| Device Name: | GALLOR DENTAL MATERIAL & COPING INTRACAST TECHNOLO |
| Classification | Alloy, Gold-based Noble Metal |
| Applicant | PRECIOUS CHEMICALS U.S.A., INC. 2151 LONG RIDGE RD. Stamford, CT 06903 |
| Contact | Eugene Lieberstein |
| Correspondent | Eugene Lieberstein PRECIOUS CHEMICALS U.S.A., INC. 2151 LONG RIDGE RD. Stamford, CT 06903 |
| Product Code | EJT |
| CFR Regulation Number | 872.3060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-05-07 |
| Decision Date | 1994-04-28 |