K032756 is an FDA 510(k) clearance for the A-DEC 532/533 DELIVERY SYSTEM MODEL, 532/533. 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 4, 2003, 90 days after receiving the submission on September 5, 2003.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K032756 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 05, 2003 |
| Decision Date | December 04, 2003 |
| Days to Decision | 90 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 |