K935960 is an FDA 510(k) clearance for the GC TEMPRON. This device is classified as a Crown And Bridge, Temporary, Resin (Class II - Special Controls, product code EBG).
Submitted by GC America, Inc. (Alsip, US). The FDA issued a Cleared decision on March 4, 1994, 81 days after receiving the submission on December 13, 1993.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3770.
| 510(k) Number | K935960 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 13, 1993 |
| Decision Date | March 04, 1994 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EBG — Crown And Bridge, Temporary, Resin |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.3770 |