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3D Dental

3D DENTAL DESIGNS AND DEVELOPMENT, LLC · Model EN23S · UDI-DI 00817169024316

EIC
10
510(k) clearances
432
Adverse events
1
Recalls
139
Facilities

Description

ENDO IRRIGATING 23GA WITH SYRINGE SIDE VENT BLUE BOX/100

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.