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Light, Operating, Dental
FDA product code EAZ · Class 1 · Dental
516
Registered devices
180
Adverse events
3
Recalls
23
510(k) clearances
Devices with this code
DCI Edge — DCI International, LLCMidmark — MIDMARK CORPORATIONForest — Ls Enterprises, Inc.DCI Edge — DCI International, LLCLUVIS-C600 Series — DENTIS CO. ,LTDDentalez — Dentalez Alabama, Inc.Midmark — MIDMARK CORPORATIONFARO — F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPAMidmark — MIDMARK CORPORATIONDCI Edge — DCI International, LLCLUVIS-C600 Series — DENTIS CO. ,LTDMidmark — MIDMARK CORPORATIONFARO — F.A.R.O. FABBRICA APPARECCHIATURE RAZIONALI ODONTOIATRICHE SPAMidmark — MIDMARK CORPORATIONForest — Ls Enterprises, Inc.LUVIS-C500 Series — DENTIS CO. ,LTDForest — Ls Enterprises, Inc.ViziLite® — DEN-MAT HOLDINGS, LLCForest — Ls Enterprises, Inc.Aseptico — ASEPTICO, INC.DCI Edge — DCI International, LLCDentalez — Dentalez Alabama, Inc.DCI Edge — DCI International, LLCMidmark — MIDMARK CORPORATION
Recent 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 |
| 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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