K071429 is an FDA 510(k) clearance for the TI2200 TRANSILLUMINATION CABLE. This device is classified as a Caries Detector, Laser Light, Transmission (Class II - Special Controls, product code NTK).
Submitted by Kerr Corporation (Orange, US). The FDA issued a Cleared decision on September 10, 2007, 110 days after receiving the submission on May 23, 2007.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.1745.
| 510(k) Number | K071429 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 23, 2007 |
| Decision Date | September 10, 2007 |
| Days to Decision | 110 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | NTK — Caries Detector, Laser Light, Transmission |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.1745 |