K955825 is an FDA 510(k) clearance for the SMITH S-100 TIME & TEMPERATURE CONTROL. This device is classified as a Processor, Radiographic-film, Automatic, Dental (Class II - Special Controls, product code EGY).
Submitted by Smith Companies Dental Products (Fremont, US). The FDA issued a Cleared decision on April 5, 1996, 101 days after receiving the submission on December 26, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1900.
| 510(k) Number | K955825 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 26, 1995 |
| Decision Date | April 05, 1996 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | EGY — Processor, Radiographic-film, Automatic, Dental |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1900 |