K961472 is an FDA 510(k) clearance for the DENTAL DAM SILICONE. This device is classified as a Dam, Rubber (Class I - General Controls, product code EIE).
Submitted by Worldwide Dental, Inc. (Concord, US). The FDA issued a Cleared decision on August 7, 1996, 112 days after receiving the submission on April 17, 1996.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.
| 510(k) Number | K961472 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 17, 1996 |
| Decision Date | August 07, 1996 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIE — Dam, Rubber |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6300 |