Duns Number:113170088
Device Description: Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups Ultra Band-Lok is intended for use as an orthodontic band cement and for occlusal buildups. Ultra Band-Lok can also be used to bond brackets, lingual retainers and large acrylic appliancesLuer Loc Ultra Band Lok kit contains: 6 5g luer loc syringes. This kit is natural shade - comes with 60 tips.
Catalog Number
LLUBL
Brand Name
Ultra Band Lok
Version/Model Number
LLUBL
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
5a5f7e8a-71ad-4d36-a0f0-c4a3b74ca0da
Public Version Date
October 29, 2018
Public Version Number
4
DI Record Publish Date
November 15, 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 |