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Planmeca Solanna

Planmeca Oy · Model Solanna · UDI-DI 06430035420544

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

Description

The Planmeca Solanna operating light gives perfect visibility over the entire treatment area with adjustable brightness and colour temperature. The light head moves smoothly to cater the needs of users of all sizes, sitting or standing. The light head with 3-axis movement is easy and effortless to position. The exceptionally long arm enables optimal working conditions for operations of all kinds.

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.