The following data is part of a premarket notification filed by Southern Dental Industries, Inc. with the FDA for Pls-96p.
| Device ID | K973088 |
| 510k Number | K973088 |
| Device Name: | PLS-96P |
| Classification | Alloy, Amalgam |
| Applicant | SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Contact | Samantha J Cheetham |
| Correspondent | Samantha J Cheetham SOUTHERN DENTAL INDUSTRIES, INC. 246 FIRST ST., SUITE 204 San Francisco, CA 94105 |
| Product Code | EJJ |
| CFR Regulation Number | 872.3070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-08-18 |
| Decision Date | 1997-10-03 |