The following data is part of a premarket notification filed by Jeneric Ind. with the FDA for Gold-palladium-silver Based Cast/alloy.
Device ID | K833736 |
510k Number | K833736 |
Device Name: | GOLD-PALLADIUM-SILVER BASED CAST/ALLOY |
Classification | Remover, Crown |
Applicant | JENERIC IND. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | EIS |
CFR Regulation Number | 872.4565 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-10-25 |
Decision Date | 1983-12-29 |