K952870 is an FDA 510(k) clearance for the REMANIUM: CS & G-SOFT. This device is classified as a Alloy, Metal, Base (Class II - Special Controls, product code EJH).
Submitted by Dentauraum, Inc. (Newtown, US). The FDA issued a Cleared decision on July 27, 1995, 35 days after receiving the submission on June 22, 1995.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3710.
| 510(k) Number | K952870 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 22, 1995 |
| Decision Date | July 27, 1995 |
| Days to Decision | 35 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EJH — Alloy, Metal, Base |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3710 |