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EdgeBurs®

US ENDODONTICS, LLC · Model 1558DCC10 · UDI-DI 00818365024834

EJL Prescription
10
510(k) clearances
532
Adverse events
13
Recalls
269
Facilities

Description

Orca Metal Cutting Bur 1558 Diamond Cut 10pk Orca DX Carbide Metal Cutting 1558 Diamond Cut 10p

Recalls

DateFirmReason
2025-02-27Premier Dental Products CoThe hardness not meeting the material specification and may cause the diamond bur to bend.
2024-01-11Brasseler USA I LpThe device has a grip detail (right angle latch) out of specification causing the bur to not adequately latch in the handpiece.
2020-10-20Coltene Whaledent IncThe FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
2020-10-20Coltene Whaledent IncThe FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
2020-10-20Coltene Whaledent IncThe FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
2020-10-20Coltene Whaledent IncThe FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
2020-10-20Coltene Whaledent IncThe FG 557 bur was incorrectly packaged as the FG 57 bur. The FG 557 burs will remove more material than the FG 57 burs.
2020-07-15Hager & Meisinger GmbhUS-dates between the product package label and the bar code display.
2019-12-23Jjgc Industria E Comercio De Materials Dentarios SaThe laser engraving of the product incorrectly identifies the 4.3 Tapered Guided Surgery Drill as the "4.3+ Tapered Guided Surgery Drill".
2019-07-19Coltene /Whaledent AGA 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 different length.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.