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Planmeca Solanna
Planmeca Oy · Model Solanna · UDI-DI 06430035420544
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
| 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.
