K112321 is an FDA 510(k) clearance for the CS 1200. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Carestream Health, Inc. (Atlanta, US). The FDA issued a Cleared decision on November 10, 2011, 90 days after receiving the submission on August 12, 2011.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K112321 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 12, 2011 |
| Decision Date | November 10, 2011 |
| Days to Decision | 90 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 |