Home › Planmeca Oy › Planmeca SingLED
Planmeca SingLED
Planmeca Oy · Model SingLED · UDI-DI 06430035420247
1
510(k) clearances
180
Adverse events
3
Recalls
78
Facilities
Description
Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology.
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. |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
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.