DZP · Instrument, Diamond, Dental
Dental · 21 CFR 872.4535 · Class 1
Overview
| Product Code | DZP |
|---|---|
| Device Name | Instrument, Diamond, Dental |
| Regulation | 21 CFR 872.4535 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental diamond instrument is an abrasive device intended to smooth tooth surfaces during the fitting of crowns or bridges. The device consists of a shaft which is inserted into a handpiece and a head which has diamond chips imbedded into it. Rotation of the diamond instrument provides an abrasive action when it contacts a tooth.
Classification Rationale
Class I. The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter.
Cleared Devices (21)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K120037 | BLUWHITE DIAMOND DENTAL BURS MODIFIED | Beavers Dental, Div. Sybron Canada, Ltd. | Apr 20, 2012 | SESE |
| K943841 | SOPHOS DENTAL DIAMOND | Sophos Technologic | Sep 16, 1994 | SESE |
| K940908 | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS | Dunhall Pharmaceuticals, Inc. | Aug 29, 1994 | SESE |
| K934981 | DENTAL DRILL | Eare Consulting Service | Feb 3, 1994 | SESE |
| K923757 | DENTAL DIAMOND DRILLS | Alpha Industrializacao DE Metais Ltda. | Mar 16, 1993 | SESE |
| K913651 | MANI DIA-BURS | The Lahr Consulting Group, Inc. | Jan 14, 1992 | SESE |
| K901967 | DENDIA WERK BURS AND CUTTING DISCS | Micro-Aire Surgical Instruments, Inc. | Jul 13, 1990 | SESE |
| K901262 | F.G. LASER (DENTAL BUR) | Diamond Rotary and Carbide Intl. | Jul 9, 1990 | SESE |
| K900089 | FG DIAMOND BURRS | Kab Gloves Unltd. | Apr 3, 1990 | SESE |
| K893844 | 3D DENTAL DIAMOND ROTARY INSTRUMENTS | Lustgarten Multi-Tech International, Inc. | Aug 11, 1989 | SESE |
| K885233 | NOVA DIAMOND | Microcopy, Div. Neo-Flo, Inc. | Feb 13, 1989 | SESE |
| K880179 | BEAVERS' DENTAL DIAMOND INSTRUMENTS | Beavers Dental, Div. Sybron Canada, Ltd. | Mar 9, 1988 | SESE |
| K871639 | DENTAL DIAMOND BURS | E&D Dental Manufacturing Co. | May 18, 1987 | SESE |
| K854347 | HYBRID POINTS | Shofu Dental Corp. | Dec 27, 1985 | SESE |
| K833038 | SUMMA DISK | Shofu Dental Corp. | Oct 4, 1983 | SESE |
| K832856 | GINGI CURETTAGE DIAMOND POINTS | Shofu Dental Corp. | Oct 4, 1983 | SESE |
| K832855 | TPE DIAMOND POINTS | Shofu Dental Corp. | Sep 29, 1983 | SESE |
| K802987 | JOTA DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE |
| K802984 | MEISINGER DIAMOND DENTAL BURS | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE |
| K780864 | DIAMOND STONES | Venture Technology, Inc. | Jun 14, 1978 | SESE |
| K760987 | DIAMOND STONES | Adp Intl., Inc. | Nov 15, 1976 | SESE |
Top Applicants
- Shofu Dental Corp. — 4 clearances
- Swiss American Metal Craft Corp. — 2 clearances
- Beavers Dental, Div. Sybron Canada, Ltd. — 2 clearances
- Venture Technology, Inc. — 1 clearance
- The Lahr Consulting Group, Inc. — 1 clearance
