Home › Device types › EJL
Bur, Dental
FDA product code EJL · Class 1 · Dental
22,929
Registered devices
523
Adverse events
13
Recalls
27
510(k) clearances
Devices with this code
Carbide burs — DFS - DIAMON GmbHKOMET Dental Tungsten Carbide Burs — Gebr. Brasseler GmbH & Co. KGKOMET Dental Tungsten Carbide Burs — Gebr. Brasseler GmbH & Co. KGKOMET Dental Tungsten Carbide Burs — Gebr. Brasseler GmbH & Co. KGHouse Brand Dentistry — Frontier Dental Supply IncAlpen — COLTENE/WHALEDENT INCAlpen — COLTENE/WHALEDENT INCn/a — Hager & Meisinger Gesellschaft mit beschränkter HaftungKOMET Dental Tungsten Carbide Burs — Gebr. Brasseler GmbH & Co. KGEDENTA — EDENTA ETABLISSEMENTSunshine Diamonds — Dr. Hopf GmbH & Co. KGEdgeBurs® — US ENDODONTICS, LLCEDENTA — EDENTA ETABLISSEMENTEDENTA — EDENTA ETABLISSEMENTECO Dental — TriRock Dental LLCCarbide rotary dental burs — PRIMA DENTAL MANUFACTURING LIMITEDAidite Dental Bur — Aidite (Qinhuangdao) Technology Co., Ltd.Carbide burs — DFS - DIAMON GmbHMigtools — MIG TOOLS INDUSTRIA E COMERCIO LTDADrill Stopper for Long L16 1852 — ADIN DENTAL IMPLANT SYSTEMS LTDACE — ACE SURGICAL SUPPLY CO., INC.Brasseler USA — Peter Brasseler Holdings, LLCJohnson-Promident — Young Innovations, Inc.Prehma — Keystone Industries
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-02-27 | Premier Dental Products Co | The hardness not meeting the material specification and may cause the diamond bur to bend. |
| 2024-01-11 | Brasseler USA I Lp | The device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-10-20 | Coltene Whaledent Inc | The FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs. |
| 2020-07-15 | Hager & Meisinger Gmbh | US-dates between the product package label and the bar code display. |
| 2019-12-23 | Jjgc Industria E Comercio De Materials Dentarios Sa | The laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill". |
| 2019-07-19 | Coltene /Whaledent AG | A single batch of Diatech Diamond dental burs, 856-016-7-F, Round end taper, contain diamond burs with the same grit size (fine) and shape (round end taper) but |
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