The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Argeloy N.p. (v) (non-precious Dental Alloy For Procelain Application).
| Device ID | K935972 |
| 510k Number | K935972 |
| Device Name: | ARGELOY N.P. (V) (NON-PRECIOUS DENTAL ALLOY FOR PROCELAIN APPLICATION) |
| Classification | Alloy, Metal, Base |
| Applicant | ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
| Contact | Dr. Manohar Lal Malhotra |
| Correspondent | Dr. Manohar Lal Malhotra ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-13 |
| Decision Date | 1994-01-26 |