K082985 is an FDA 510(k) clearance for the A-DEC 334/335 DELIVERY SYSTEM. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by A-Dec, Inc. (Newberg, US). The FDA issued a Cleared decision on December 17, 2008, 71 days after receiving the submission on October 7, 2008.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K082985 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 07, 2008 |
| Decision Date | December 17, 2008 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Statement |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |