The following data is part of a premarket notification filed by Addent, Inc. with the FDA for Microlux Dl.
| Device ID | K041614 |
| 510k Number | K041614 |
| Device Name: | MICROLUX DL |
| Classification | Light, Operating, Dental |
| 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 | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-06-15 |
| Decision Date | 2005-04-04 |
| Summary: | summary |