K012511 is an FDA 510(k) clearance for the WATERLASE MILLENNIUM. This device is classified as a System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation (Class II - Special Controls, product code MXF).
Submitted by Biolase Technology, Inc. (Clemente, US). The FDA issued a Cleared decision on January 18, 2002, 165 days after receiving the submission on August 6, 2001.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K012511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 06, 2001 |
| Decision Date | January 18, 2002 |
| Days to Decision | 165 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | MXF — System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 872.4120 |