DEVICE: Pad Lock (D798PLPKPLUS0)
Device Identifier (DI) Information
Pad Lock
PLPKPLUS
In Commercial Distribution
PLPKPLUS
RELIANCE ORTHODONTIC PRODUCTS INC
PLPKPLUS
In Commercial Distribution
PLPKPLUS
RELIANCE ORTHODONTIC PRODUCTS INC
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
Kit contains 18g Padlock adhesive paste in push syringes, 1 X 6ccAssure Plus Bonding Resin, 9 gm liquid etchant, mixing pad, spatulas and brush applicators.
This kit is non-Fluoride.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
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Yes | |
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No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
31750 | Orthodontic bracket adhesive |
A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.
|
Active | false |
34782 | Dentine bonding agent/set |
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
DYH | Adhesive, Bracket And Tooth Conditioner, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Store refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temper ature prior to use. |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
a6ac6b84-a6c1-4470-bd9c-d954515b5611
February 16, 2024
3
August 10, 2016
February 16, 2024
3
August 10, 2016
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
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No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com