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CEFLA
CEFLA SOCIETA' COOPERATIVA · Model VENUS PLUS · UDI-DI 08033837937494
EAZ
Prescription
10
510(k) clearances
180
Adverse events
3
Recalls
78
Facilities
Description
The device is a dental operating light intended to illuminate oral structures and operating areas during dental treatment.
Recalls
| Date | Firm | Reason |
|---|---|---|
| 2016-03-08 | Pelton & Crane / Marus / DCI Equipment / KaVo | The 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 |
| 2011-05-27 | Dental Equipment LLC | Lens heat shield (birdcage) of the Luxstar Dental Light could fall and injure a patient. |
| 2007-05-01 | Dental Equipment LLC | Potential for light shield to melt due to light assemblies not properly rated to handle the VAC. |
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Get your free API keyRead the docsData 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.