The following data is part of a premarket notification filed by Argen Precious Metals, Inc. with the FDA for Surefire Pf+ (high Palladium Dental Casting Alloy For Porcelain Applications).
| Device ID | K950894 |
| 510k Number | K950894 |
| Device Name: | SUREFIRE PF+ (HIGH PALLADIUM DENTAL CASTING ALLOY FOR PORCELAIN APPLICATIONS) |
| Classification | Alloy, Metal, Base |
| Applicant | ARGEN PRECIOUS METALS, INC. 8380 MIRALANI DR. San Diego, CA 92126 |
| Contact | Manohar L Malhotra |
| Correspondent | Manohar L 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 | 1995-02-27 |
| Decision Date | 1995-03-31 |