Duns Number:828813290
Device Description: Synthetic bone void filler for dental applications
Catalog Number
NA1612
Brand Name
Dental Putty Syringe 2.0cc
Version/Model Number
NA1612
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
Product Code
LYC
Product Code Name
Bone Grafting Material, Synthetic
Public Device Record Key
e8baaa5e-08b7-4b2d-9686-927b76a22d87
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
March 07, 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 |