EJL · Bur, Dental
Dental · 21 CFR 872.3240 · Class 1
Overview
| Product Code | EJL |
|---|---|
| Device Name | Bur, Dental |
| Regulation | 21 CFR 872.3240 |
| Device Class | Class 1 |
| Review Panel | Dental |
Identification
A dental bur is a rotary cutting device made from carbon steel or tungsten carbide intended to cut hard structures in the mouth, such as teeth or bone. It is also intended to cut hard metals, plastics, porcelains, and similar materials intended for use in the fabrication of dental devices.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.
Recent Cleared Devices (20 of 27)
Showing 20 most recent of 27 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K080687 | SMARTBURS | S.S. White Burs, Inc. | Jun 20, 2008 | SESE |
| K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG | Jun 29, 2007 | SESE |
| K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.T.I. Biotechnology Institute, Sl. | Aug 3, 2006 | SESE |
| K943273 | TRI HAWK BUR, FG BUR | Tri Hawk Corp. | Aug 1, 1994 | SESE |
| K926205 | MONOSTERYL | Utensili Super Abrasivi | Feb 10, 1994 | SESE |
| K923883 | DENTAL OR SURGICAL BUR | Stratum Dental Technologies, Inc. | Jul 27, 1993 | SESE |
| K921406 | SILICONT BUR BLOCK | Innovators, Inc. | Apr 28, 1992 | SESE |
| K920243 | SMART BURS TOTAL CARBIDES | Vermont Diamond Instruments | Mar 25, 1992 | SESE |
| K911208 | TIN COATED DENTAL BURS | Surgical Precision Instruments, Corp. | Sep 16, 1991 | SESE |
| K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | Brevet, Inc. | May 23, 1991 | SESE |
| K882183 | DENTAL BURS | Tri-Stage, Inc. | Jun 21, 1988 | SESE |
| K873698 | STERILIZED DENTAL BIT PACKAGING | Florida Diamond Instruments Corp. | Dec 3, 1987 | SESE |
| K863097 | CB BUR | Beavers Dental, Div. Sybron Canada, Ltd. | Aug 26, 1986 | SESE |
| K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. | Mar 25, 1986 | SESE |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. | Mar 25, 1986 | SESE |
| K842720 | BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL | Penn-Med Technology, Inc. | May 21, 1985 | SESE |
| K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. | Dec 29, 1983 | SESE |
| K823314 | DENTAL INSTRUMENTS | Miltex, Inc. | Nov 24, 1982 | SESE |
| K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE |
| K802988 | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS | Swiss American Metal Craft Corp. | Dec 30, 1980 | SESE |
Top Applicants
- Swiss American Metal Craft Corp. — 2 clearances
- Almore Intl., Inc. — 2 clearances
- Vermont Diamond Instruments — 1 clearance
- Utensili Super Abrasivi — 1 clearance
- Tri-Stage, Inc. — 1 clearance
