MXF
5 FDA 510(k) clearances · Product code
78 daysmedian time to decision
165 days90th percentile
5clearances measured
FDA profile
- Official device name
- System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 872.4120
- Medical specialty
- Dental
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| WATERLASE FOR APICOECTOMY (K022803) | Biolase Technology, Inc. | 2003-02-03 |
| WATERLASE MILLENNIUM (K013908) | Biolase Technology, Inc. | 2002-02-12 |
| WATERLASE MILLENNIUM (K012511) | Biolase Technology, Inc. | 2002-01-18 |
| MILLENNIUM (K990908) | Endo Technic Corp. | 1999-05-27 |
| MODIFICATION OF MILLENNIUM (K990219) | Biolase Technology, Inc. | 1999-02-24 |
Track MXF automatically
Every clearance here is in the API, with alerts when new ones post.