The following data is part of a premarket notification filed by Neks Technologies, Inc. with the FDA for D-carie, Model N121-m1.
| Device ID | K043156 |
| 510k Number | K043156 |
| Device Name: | D-CARIE, MODEL N121-M1 |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | NEKS TECHNOLOGIES, INC. 208 BARRINGTON OVERLOOK DRIVE Durham, NC 27703 |
| Contact | Charles H Kyper |
| Correspondent | Charles H Kyper NEKS TECHNOLOGIES, INC. 208 BARRINGTON OVERLOOK DRIVE Durham, NC 27703 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-11-15 |
| Decision Date | 2005-04-28 |
| Summary: | summary |