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AXIOM®

ETABLISSEMENTS ANTHOGYR · Model 10401XL · UDI-DI 03663394169936

EFA Prescription
10
510(k) clearances
220
Adverse events
3
Recalls
19
Facilities

Description

IMPL. CA WITH LIGHT+DEPTH STOP

Recalls

DateFirmReason
2014-06-13Dental EZ Group Star Dental DivisionThe housing of 5K motor was laser marked incorrectly as a 20K motor. The recall was expanded in September 2014 to include additional lot #2251181.
2010-08-11Dental EZ Stardental DivisionThe housing of 5K motor is labeled as a 20K motor.
2006-12-01Stardental DivisionEnd cap component can disassemble.

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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.