Pad Lock - Pad Lock® is intended for use as a fluorescing, - RELIANCE ORTHODONTIC PRODUCTS INC

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.

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More Product Details

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

Product Characteristics

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 Details

Product Code

DYH

Product Code Name

Adhesive, Bracket And Tooth Conditioner, Resin

Device Record Status

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

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"RELIANCE ORTHODONTIC PRODUCTS INC" Characteristics
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