K895283 is an FDA 510(k) clearance for the PROSTHETIC RESTORATION DEVICE. This device is classified as a Pin, Retentive And Splinting, And Accessory Instruments (Class I - General Controls, product code EBL).
Submitted by Swiss Precision Mfg. Corp. (Bayshore, US). The FDA issued a Cleared decision on February 14, 1990, 174 days after receiving the submission on August 24, 1989.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3740.
| 510(k) Number | K895283 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 24, 1989 |
| Decision Date | February 14, 1990 |
| Days to Decision | 174 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | — |
| Product Code | EBL — Pin, Retentive And Splinting, And Accessory Instruments |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.3740 |