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DCI Edge

DCI International, LLC · Model RP · UDI-DI 00810021437293

EAZ
10
510(k) clearances
180
Adverse events
3
Recalls
78
Facilities

Description

Post Mount Reliance Light, 120 Volt, White

Recalls

DateFirmReason
2016-03-08Pelton & Crane / Marus / DCI Equipment / KaVoThe firm received two customer complaints local Pelton & Crane distributors that the Helios 3000 track mounted dental lights were missing the two 8/32x3/16 set screws during the in
2011-05-27Dental Equipment LLCLens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient.
2007-05-01Dental Equipment LLCPotential for light shield to melt due to light assemblies not properly rated to handle the VAC.

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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.