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 adhesive.This is a Thin Viscosity Kit in Tip Dispensing. It contains (4) 4.5g Thin Paste in syringe tips, (2) 3cc Light Bond™ sealants, 9g Etching agent (liquid or gel), mixing pad, spatulas and brushes.This is a non-Fluoride Kit.
Catalog Number
PLTTK
Brand Name
Pad Lock
Version/Model Number
PLTTK
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
06c62abf-5fbe-4be4-86f3-99df85216120
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
August 05, 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 |