Duns Number:113170088
Device Description: Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. P Pad Lock® is intended for use as a fluorescing, light cure orthodontic bracket adhesive. Pad Lock® paste will fluoresce when illuminated with a black light to reveal flash upon bracket placement. In addition, the cured paste under the bracket base will fluoresce at the time of debonding making it easier to see and remove the adhesiveKit contains 18g adhesive paste in syringe tips, 1 X Assure Plus Bonding Resin, 9 gm liquid etchant, mixing pad, spatulas and brush applicators.This kit contains Fluoride.
Catalog Number
PLTKFPLUS
Brand Name
Pad Lock
Version/Model Number
PLTKFPLUS
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
September 04, 2016
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
1d7d6a63-dfff-43c2-9f44-3e788444095d
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 10, 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 |