Duns Number:368788568
Device Description: Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED Planmeca SingLED is a dental operating light providing ultra-bright light with modern LED technology.
Catalog Number
10020815
Brand Name
Planmeca SingLED
Version/Model Number
SingLED
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K923462
Product Code
EAZ
Product Code Name
Light, Operating, Dental
Public Device Record Key
3ca667aa-d1f1-415f-a27c-c1babcd5eb79
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
May 05, 2017
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 7 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 20 |