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MDT Tungsten Carbide Dental Burs -Sterile

M.D.T. - MICRO DIAMOND TECHNOLOGIES LTD. · Model 5006SL18-R8-8C · UDI-DI 67291046608564

EJL
10
510(k) clearances
523
Adverse events
13
Recalls
267
Facilities

Description

Rotary carbide instrument for dental application sterile

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.