The following data is part of a premarket notification filed by Neks Technologies, Inc. with the FDA for D-carie/detectar, Models N121, N123, N133, N134, N135 & N138.
| Device ID | K063321 |
| 510k Number | K063321 |
| Device Name: | D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 |
| Classification | Laser, Fluorescence Caries Detection |
| Applicant | NEKS TECHNOLOGIES, INC. 2816, JOSEPH A. BOMBARDIER Laval, Quebec, CA H7p 6e2 |
| Contact | Naim Karazivan |
| Correspondent | Naim Karazivan NEKS TECHNOLOGIES, INC. 2816, JOSEPH A. BOMBARDIER Laval, Quebec, CA H7p 6e2 |
| Product Code | NBL |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-11-02 |
| Decision Date | 2007-03-30 |
| Summary: | summary |