K102234 is an FDA 510(k) clearance for the A-DEC 200 DENTAL 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 November 24, 2010, 107 days after receiving the submission on August 9, 2010.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K102234 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 09, 2010 |
| Decision Date | November 24, 2010 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EIA — Unit, Operative Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.6640 |