K091186 is an FDA 510(k) clearance for the KODAK 1500 INTRAORAL CAMERA. 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 August 18, 2009, 117 days after receiving the submission on April 23, 2009.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K091186 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 23, 2009 |
| Decision Date | August 18, 2009 |
| Days to Decision | 117 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 |