K022803 is an FDA 510(k) clearance for the WATERLASE FOR APICOECTOMY. 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 February 3, 2003, 164 days after receiving the submission on August 23, 2002.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4120.
| 510(k) Number | K022803 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 23, 2002 |
| Decision Date | February 03, 2003 |
| Days to Decision | 164 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 |