MXF · System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | MXF |
|---|---|
| Device Name | System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation |
| Regulation | 21 CFR 872.4120 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
A bone cutting instrument and accessories is a metal device intended for use in reconstructive oral surgery to drill or cut into the upper or lower jaw and may be used to prepare bone to insert a wire, pin, or screw. The device includes the manual bone drill and wire driver, powered bone drill, rotary bone cutting handpiece, and AC-powered bone saw.
Classification Rationale
Class II.
Recent Cleared Devices (5 of 5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K022803 | WATERLASE FOR APICOECTOMY | Biolase Technology, Inc. | Feb 3, 2003 | SESE |
| K013908 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | Feb 12, 2002 | SESE |
| K012511 | WATERLASE MILLENNIUM | Biolase Technology, Inc. | Jan 18, 2002 | SESE |
| K990908 | MILLENNIUM | Endo Technic Corp. | May 27, 1999 | SESE |
| K990219 | MODIFICATION OF MILLENNIUM | Biolase Technology, Inc. | Feb 24, 1999 | SESE |
Top Applicants
- Biolase Technology, Inc. — 4 clearances
- Endo Technic Corp. — 1 clearance
