Duns Number:113170088
Device Description: Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. K Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Kit contains 18g Padlock adhesive paste in tips, 1 x 6ml Assure Plus Bonding Resin, 1 X 9 gm liquid etchant, and mixing accessories
Catalog Number
PLTKPLUS
Brand Name
Pad Lock
Version/Model Number
PLTKPLUS
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
DYH
Product Code Name
Adhesive, Bracket And Tooth Conditioner, Resin
Public Device Record Key
f217380a-6675-4da1-86e3-44f393afe3f7
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 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 |