K781520 is an FDA 510(k) clearance for the RUBBER DAM HOLDER. This device is classified as a Frame, Rubber Dam (Class I - General Controls, product code EJE).
Submitted by Young Dental Manufacturing Co. 1, LLC (Mchenry, US). The FDA issued a Cleared decision on October 10, 1978, 39 days after receiving the submission on September 1, 1978.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6300.
| 510(k) Number | K781520 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1978 |
| Decision Date | October 10, 1978 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | - |
| Product Code | EJE - Frame, Rubber Dam |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6300 |