The following data is part of a premarket notification filed by Dentauraum, Inc. with the FDA for Remanium: 200,cs, 380, And Cd.
| Device ID | K952865 |
| 510k Number | K952865 |
| Device Name: | REMANIUM: 200,CS, 380, AND CD |
| Classification | Alloy, Metal, Base |
| Applicant | DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Contact | John J Roth, Jr. |
| Correspondent | John J Roth, Jr. DENTAURAUM, INC. 10 PHEASANT RUN Newtown, PA 18940 |
| Product Code | EJH |
| CFR Regulation Number | 872.3710 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-22 |
| Decision Date | 1995-07-26 |