Duns Number:113170088
Device Description: Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is the Band Lok is a two paste dual-cure adhesive intended for use as a band cement. This is the Self Mixing Kit that includes 60 self mixing tips. The adhesive is blue shade.
Catalog Number
SMBLBK
Brand Name
Band Lok
Version/Model Number
SMBLBK
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 21, 2017
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
3c8591b6-e22d-476f-acf9-bca6f4bd7661
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
August 01, 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 |
|---|---|---|
| 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 |