The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Microlux Transilluminator.
| Device ID | K062961 |
| 510k Number | K062961 |
| Device Name: | MICROLUX TRANSILLUMINATOR |
| Classification | Caries Detector, Laser Light, Transmission |
| Applicant | ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Contact | Joshua Friedman |
| Correspondent | Joshua Friedman ADDENT, INC. 43 MIRY BROOK RD. Danbury, CT 06810 |
| Product Code | NTK |
| CFR Regulation Number | 872.1745 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-09-29 |
| Decision Date | 2007-02-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| D86962000706 | K062961 | 000 |
| D86911008001 | K062961 | 000 |