Duns Number:113170088
Device Description: Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildup Ultra Band-Lok® is intended for use as an orthodontic band cement and for occlusal buildups.This product is Natural shade.This product is Non-Fluoride.This product is a Luer Lok Syringe with Tips.
Catalog Number
NFLLUBLPP
Brand Name
Ultra Band Lok
Version/Model Number
NFLLUBLPP
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
April 25, 2019
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
b6fa0dd5-a725-4251-8dcd-2d983b42f344
Public Version Date
April 26, 2019
Public Version Number
5
DI Record Publish Date
March 24, 2017
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 |