K041614 is an FDA 510(k) clearance for the MICROLUX DL. This device is classified as a Light, Operating, Dental (Class I - General Controls, product code EAZ).
Submitted by Addent, Inc. (Danbury, US). The FDA issued a Cleared decision on April 4, 2005, 293 days after receiving the submission on June 15, 2004.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4630.
| 510(k) Number | K041614 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 15, 2004 |
| Decision Date | April 04, 2005 |
| Days to Decision | 293 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EAZ — Light, Operating, Dental |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4630 |