The following data is part of a premarket notification filed by Precious Chemicals U.s.a., Inc. with the FDA for Ucc Dental Material.
Device ID | K023790 |
510k Number | K023790 |
Device Name: | UCC DENTAL MATERIAL |
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 | 2002-11-13 |
Decision Date | 2003-01-21 |