The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Argi-satin Or Opti0-star.
| Device ID | K965216 |
| 510k Number | K965216 |
| Device Name: | ARGI-SATIN OR OPTI0-STAR |
| Classification | Teeth, Porcelain |
| Applicant | ARGEN PRECIOUS METALS, INC. 5855 OBERLIN DR. San Diego, CA 92121 -4718 |
| Contact | Paul J Cascone |
| Correspondent | Paul J Cascone ARGEN PRECIOUS METALS, INC. 5855 OBERLIN DR. San Diego, CA 92121 -4718 |
| Product Code | ELL |
| CFR Regulation Number | 872.3920 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-12-30 |
| Decision Date | 1997-02-27 |