Duns Number:138121202
Device Description: Qty 1 - 15610001 - Emerald Scanner (US)Qty 1 - 15600101 - Emerald Scanner Accessories(Incl Qty 1 - 15610001 - Emerald Scanner (US)Qty 1 - 15600101 - Emerald Scanner Accessories(Includes 1 Scanner Cable, 1 Color Balancer, 3 Tips)
Catalog Number
-
Brand Name
Planmeca Emerald
Version/Model Number
156100001 Emerald Scanner Kit - US
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)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
NOF
Product Code Name
System, Optical Impression, Computer Assisted Design And Manufacturing (Cad/Cam) Of Dental Restorations
Public Device Record Key
f3e8528b-d37c-48bd-b505-290a3f8e9cd6
Public Version Date
February 21, 2022
Public Version Number
3
DI Record Publish Date
March 01, 2019
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 |
---|---|---|
2 | A medical device with a moderate to high risk that requires special controls. | 11 |