Duns Number:113170088
Device Description: BandLok is intended for use as a chemical cure band cement.This is the 6 gm syringe of Par BandLok is intended for use as a chemical cure band cement.This is the 6 gm syringe of Part A, natural shade.This is a NonFluoride Device
Catalog Number
NFBLSA
Brand Name
BandLok
Version/Model Number
NFBLSA
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In HIBCC
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
EBF
Product Code Name
Material, Tooth Shade, Resin
Public Device Record Key
5e4b8b67-7114-44bc-a302-572b206edc7e
Public Version Date
December 17, 2018
Public Version Number
1
DI Record Publish Date
November 14, 2018
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 | 73 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 279 |