Duns Number:828813290
Device Description: Synthetic bone void filler for dental applications
Catalog Number
NA0660
Brand Name
Dental Putty - 6 x 0.5cc
Version/Model Number
NA0660
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
Yes
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
K100671,K100671
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
bb348908-c63e-43ee-8a3b-2b496d8cf5a3
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 09, 2016
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. | 80 |