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Dental Engineering Lab-TFRK

DENTAL ENGINEERING LABORATORIES, LLC · Model TFRK-SET · UDI-DI 00850001745017

NYD Prescription
0
510(k) clearances
0
Adverse events
1
Recalls
10
Facilities

Description

Terauchi File Retrieval Kit w/ Satelec Ultrasonic Tips

Recalls

DateFirmReason
2022-11-02Stradis Medical, LLC dba Stradis HealthcareMedical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may result in a breach in

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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.