K040116 is an FDA 510(k) clearance for the HAWK INTRAORAL CAMERA AND ACCESSORIES. This device is classified as a Unit, Operative Dental (Class I - General Controls, product code EIA).
Submitted by Dxm Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on April 20, 2004, 91 days after receiving the submission on January 20, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.6640.
| 510(k) Number | K040116 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 20, 2004 |
| Decision Date | April 20, 2004 |
| Days to Decision | 91 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 |