Product code EJL
- Device name
- Bur, Dental
- Medical specialty
- Dental
- Device class
- 1
- Regulation number
- 872.3240
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K080687 | SMARTBURS | S.S. White Burs, Inc. | 2008-06-20 |
| K071352 | CERADRILL | Gebr. Brasseler GmbH & Co. KG | 2007-06-29 |
| K061383 | BTI STERILE DENTAL DRILLS KIT, BTI ABUTMENTS AND CAPS | B.T.I. Biotechnology Institute, Sl. | 2006-08-03 |
| K943273 | TRI HAWK BUR, FG BUR | Tri Hawk Corp. | 1994-08-01 |
| K926205 | MONOSTERYL | Utensili Super Abrasivi | 1994-02-10 |
| K923883 | DENTAL OR SURGICAL BUR | Stratum Dental Technologies, Inc. | 1993-07-27 |
| K921406 | SILICONT BUR BLOCK | Innovators, Inc. | 1992-04-28 |
| K920243 | SMART BURS TOTAL CARBIDES | Vermont Diamond Instruments | 1992-03-25 |
| K911208 | TIN COATED DENTAL BURS | Surgical Precision Instruments, Corp. | 1991-09-16 |
| K910794 | SMALL INSTRUMENT STERILIZATION/BUR BOX | Brevet, Inc. | 1991-05-23 |
| K882183 | DENTAL BURS | Tri-Stage, Inc. | 1988-06-21 |
| K873698 | STERILIZED DENTAL BIT PACKAGING | Florida Diamond Instruments Corp. | 1987-12-03 |
| K863097 | CB BUR | Beavers Dental, Div. Sybron Canada, Ltd. | 1986-08-26 |
| K854690 | DIAMONDS BURS-COMPOSIT FINISHING | Almore Intl., Inc. | 1986-03-25 |
| K854691 | DIAMOND BURS-HANDPIECE | Almore Intl., Inc. | 1986-03-25 |
| K842720 | BUR, DENTAL GUTTA PERCHA-FILE-PULP CANAL | Penn-Med Technology, Inc. | 1985-05-21 |
| K833598 | LEBLOND DIAMOND DENTAL BUR | A & M Instruments, Inc. | 1983-12-29 |
| K823314 | DENTAL INSTRUMENTS | Miltex, Inc. | 1982-11-24 |
| K802988 | JOTA TUNGSTEN CARBIDE & STEEL DENT. BURS | Swiss American Metal Craft Corp. | 1980-12-30 |
| K802989 | MEISINGER TUNGSTEN CARBIDE & STEEL DT.B. | Swiss American Metal Craft Corp. | 1980-12-30 |
| K801886 | BURR, DENTAL | Aesculap Instruments Corp. | 1980-08-20 |
| K780641 | DENTAL ROTARY CARBIDE BURS 76EJL | Teledyne Densco | 1978-04-21 |
| K771347 | R&R ALSTON CARBIDE BURS | Ransom and Randolph | 1977-08-03 |
| K771214 | SUPERFINE DIAMONDS | Den-Mat Corp. | 1977-07-15 |
| K770469 | CUTTER TUNGSTEN CARBIDE BURS | Cutter Laboratories, Inc. | 1977-03-16 |
| K770093 | DENTAL BURS | The S. S. White Co. | 1977-01-24 |
| K760986 | CARBIDE DENTAL BURS | Adp Intl., Inc. | 1976-11-15 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D8120513291 | BUSCH®, BNA® | BUSCH & CO. GmbH & Co. KG | 2026-06-01 |
| D8120513301 | BUSCH®, BNA® | BUSCH & CO. GmbH & Co. KG | 2026-06-01 |
| 00887919170488 | Brasseler USA Sterile Carbide | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 07908611200822 | TUNGSTEN CARBIDE CUTTING BUR CC136FX LOW SPEED - 1UN | ORTHOMETRIC - INDUSTRIA E COMERCIO DE PRODUTOS MEDICOS E ODONTOLOGICOS LTDA | 2026-05-27 |
| 08404535030006 | Brasseler USA Sterile Carbide | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08404535030037 | Brasseler USA Sterile Carbide | Peter Brasseler Holdings, LLC | 2026-05-27 |
| 08435389830436 | EXTRA SHORT DRILL; Ø3.5 MM | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| 08435389830542 | FLATTENING FRONT CUTTING DRILL; Ø3.1 | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| 08435389830559 | FLATTENING FRONT CUTTING SHORT DRILL; Ø3.1 | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| 08435389831266 | FLATTENING FRONT CUTTING DRILL, Ø4.1 INTERNA 3.0 | BIOTECHNOLOGY INSTITUTE SL | 2026-05-27 |
| 00842092112113 | Preat Implant Prosthetics | Preat Corporation | 2023-07-03 |
| ESUNC12040095 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-28 |
| ESUNC12040085 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-28 |
| ESUNC12040065 | Sunshine Diamonds | Dr. Hopf GmbH & Co. KG | 2023-06-28 |
| EMICCPF10071 | Ena Post | MICERIUM SPA | 2023-05-03 |
| ESAM22349061 | STOMA® | Storz am Mark GmbH | 2022-11-07 |
| ESAM22349071 | STOMA® | Storz am Mark GmbH | 2022-11-07 |
| ESAM22349081 | STOMA® | Storz am Mark GmbH | 2022-11-07 |
| ESAM22349091 | STOMA® | Storz am Mark GmbH | 2022-11-07 |
| 00842092167601 | Preat | Preat Corporation | 2022-10-25 |
| 00842092112076 | Preat | Preat Corporation | 2022-10-25 |
| ESAM13388031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13388041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13388051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM13388061 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM22349021 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM22349031 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM22349041 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM22349051 | STOMA® | Storz am Mark GmbH | 2020-08-27 |
| ESAM23072081 | STOMA® | Storz am Mark GmbH | 2020-08-27 |