Bur, Dental
FDA product code EJL · Class I (low risk) · 21 CFR 872.3240 · Dental
27510(k) clearances
0PMA approvals
13recalls
Manufacturers
- Swiss American Metal Craft Corp. 2
- Almore Intl., Inc. 2
- Penn-Med Technology, Inc. 1
- S.S. White Burs, Inc. 1
- Stratum Dental Technologies, Inc. 1
- Innovators, Inc. 1
- Vermont Diamond Instruments 1
- Surgical Precision Instruments, Corp. 1
- Brevet, Inc. 1
- Tri-Stage, Inc. 1
- Florida Diamond Instruments Corp. 1
- Beavers Dental, Div. Sybron Canada, Ltd. 1
- Adp Intl., Inc. 1
- A & M Instruments, Inc. 1
- Miltex, Inc. 1
- Aesculap Instruments Corp. 1
- Teledyne Densco 1
- Ransom and Randolph 1
- Den-Mat Corp. 1
- Cutter Laboratories, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K080687 | SmartbursEJL · Traditional | S.S. White Burs, Inc. | 06/20/2008SE |
| K071352 | CeradrillEJL · Traditional | Gebr. Brasseler GmbH & Co. KG | 06/29/2007SE |
| K061383 | Bti Sterile Dental Drills Kit, Bti Abutments and CapsEJL · Traditional | B.T.I. Biotechnology Institute, Sl. | 08/03/2006SE |
| K943273 | Tri Hawk Bur, FG BurEJL · Traditional | Tri Hawk Corp. | 08/01/1994SE |
| K926205 | MonosterylEJL · Traditional | Utensili Super Abrasivi | 02/10/1994SE |
| K923883 | Dental or Surgical BurEJL · Traditional | Stratum Dental Technologies, Inc. | 07/27/1993SE |
| K921406 | Silicont Bur BlockEJL · Traditional | Innovators, Inc. | 04/28/1992SE |
| K920243 | Smart Burs Total CarbidesEJL · Traditional | Vermont Diamond Instruments | 03/25/1992SE |
| K911208 | Tin Coated Dental BursEJL · Traditional | Surgical Precision Instruments, Corp. | 09/16/1991SE |
| K910794 | Small Instrument Sterilization/Bur BoxEJL · Traditional | Brevet, Inc. | 05/23/1991SE |
| K882183 | Dental BursEJL · Traditional | Tri-Stage, Inc. | 06/21/1988SE |
| K873698 | Sterilized Dental Bit PackagingEJL · Traditional | Florida Diamond Instruments Corp. | 12/03/1987SE |
| K863097 | CB BurEJL · Traditional | Beavers Dental, Div. Sybron Canada, Ltd. | 08/26/1986SE |
| K854691 | Diamond Burs-HandpieceEJL · Traditional | Almore Intl., Inc. | 03/25/1986SE |
| K854690 | Diamonds Burs-Composit FinishingEJL · Traditional | Almore Intl., Inc. | 03/25/1986SE |
| K842720 | Bur, Dental Gutta Percha-File-Pulp CanalEJL · Traditional | Penn-Med Technology, Inc. | 05/21/1985SE |
| K833598 | Leblond Diamond Dental BurEJL · Traditional | A & M Instruments, Inc. | 12/29/1983SE |
| K823314 | Dental InstrumentsEJL · Traditional | Miltex, Inc. | 11/24/1982SE |
| K802989 | Meisinger Tungsten Carbide & Steel Dt.B.EJL · Traditional | Swiss American Metal Craft Corp. | 12/30/1980SE |
| K802988 | Jota Tungsten Carbide & Steel Dent. BursEJL · Traditional | Swiss American Metal Craft Corp. | 12/30/1980SE |
| K801886 | Burr, DentalEJL · Traditional | Aesculap Instruments Corp. | 08/20/1980SE |
| K780641 | Dental Rotary Carbide Burs 76EJLEJL · Traditional | Teledyne Densco | 04/21/1978SE |
| K771347 | R&R Alston Carbide BursEJL · Traditional | Ransom and Randolph | 08/03/1977SE |
| K771214 | Superfine DiamondsEJL · Traditional | Den-Mat Corp. | 07/15/1977SE |
| K770469 | Cutter Tungsten Carbide BursEJL · Traditional | Cutter Laboratories, Inc. | 03/16/1977SE |
| K770093 | Dental BursEJL · Traditional | The S. S. White Co. | 01/24/1977SE |
| K760986 | Carbide Dental BursEJL · Traditional | Adp Intl., Inc. | 11/15/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1408-2025 Class II | Premier Solo Diamond - Large Invented Cone; SKU: 807016C.The hardness not meeting the material specification and may cause the diamond bur to bend. | Premier Dental Products Co | 02/27/2025Open, Classified |
| Z-1008-2024 Class II | Brasseler 8S RA SHP RD (Super-Sharp Round) H1S.21.023, REF 001156T0), carbide dental…The device has a grip detail (right angle latch) out of specification causing the bur to not adequately… | Brasseler USA I Lp | 01/11/2024Open, Classified |
| Z-0468-2021 Class II | Strauss 25 Carbide Dental Burs (100057XXV)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | Coltene Whaledent Inc | 10/20/2020Open, Classified |
| Z-0467-2021 Class II | CEI Cutting Edge Instruments (PTC-57C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | Coltene Whaledent Inc | 10/20/2020Open, Classified |
| Z-0466-2021 Class II | Clinic Pack 100 Pieces FG 57 100057C (100057C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | Coltene Whaledent Inc | 10/20/2020Open, Classified |
| Z-0465-2021 Class II | FG 57 100057X (100057X)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | Coltene Whaledent Inc | 10/20/2020Open, Classified |
| Z-0464-2021 Class II | Alpen Clinic 100 Carbide Instruments (R100057C)The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the… | Coltene Whaledent Inc | 10/20/2020Open, Classified |
| Z-2937-2020 Class II | SINGLES Carbide US-No. FG556; UDI +E0HM26000313140091; STERILE R; Size 009, Length 3.8…US-dates between the product package label and the bar code display. | Hager & Meisinger Gmbh | 07/15/2020Terminated |
| Z-0924-2020 Class II | Neodent Tapered Guided Surgery Drill, Article No. 103.436. UDI 07899878030041. The…The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+… | Jjgc Industria E Comercio De Materials… | 12/23/2019Terminated |
| Z-2436-2019 Class II | DIATECH, swiss dental instruments, ROUND END TAPER, 856-016-7-FA single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the… | Coltene /Whaledent AG | 07/19/2019Terminated |
| Z-0493-2020 Class II | Singles carbides by Meisinger, US-No: 245, Sterile R, cylinder round end; US-No 245…Incorrect packaging; There is a potential that a 1.0 mm carbide blade was packaged in a 0.9 mm carbide blade… | Hager & Meisinger Gmbh | 11/07/2018Open, Classified |
| Z-1883-2018 Class II | Alpen Carbide 702 Cross Cut Tapered Fissure FG 10 pack (Carbide Burs), Model R100702 a…The products are labeled with an incorrect product number. | Coltene Whaledent Inc | 04/13/2018Terminated |
| Z-1949-2009 | BIOMET MICROFIXATION Trauma One SYSTEM 1.8X115 MM STOP DRILL, 1.8X115 MM WITH 26 MM STOP…Biomet Microfixation is recalling the 46-1004, Trauma One Drill, 18.x115 mm, 26 mm Stop Lot Numbers 619450… | Biomet Microfixation, Inc. | 02/16/2009Terminated |