DZH · Saw, Bone, Ac-Powered
Dental · 21 CFR 872.4120 · Class 2
Overview
| Product Code | DZH |
|---|---|
| Device Name | Saw, Bone, Ac-Powered |
| 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.
Cleared Devices (4)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K031793 | DENTATUS OSCIOMAT | Dentatus USA , Ltd. | Nov 13, 2003 | SESE |
| K935443 | ADD LINE DEVICES(PARTS) ELECTRIC HANDPIECE SYSTEMS | Osada Electric Co., Ltd. | Sep 20, 1994 | SESE |
| K760958 | SURGICAL OSCILLATING SAW | American Safety Equipment Corp. | Nov 16, 1976 | SESE |
| K760957 | SURGICAL RECIPROCATING SAW | American Safety Equipment Corp. | Nov 15, 1976 | SESE |
Top Applicants
- American Safety Equipment Corp. — 2 clearances
- Osada Electric Co., Ltd. — 1 clearance
- Dentatus USA , Ltd. — 1 clearance
