K213932 is an FDA 510(k) clearance for the A-dec 300, A-dec 500. 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 March 2, 2022, 76 days after receiving the submission on December 16, 2021.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K213932 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 16, 2021 |
| Decision Date | March 02, 2022 |
| Days to Decision | 76 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 |