DEVICE: Pad Lock (D798PLTKF0)

Device Identifier (DI) Information

Pad Lock
PLTKF
Not in Commercial Distribution
PLTKF
RELIANCE ORTHODONTIC PRODUCTS INC
D798PLTKF0
HIBCC
December 21, 2017
1
113170088 *Terms of Use
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 tips, 2 x 3cc Light Bond Sealant Resins, 9 gm liquid etchant, mixing pad, spatulas and brush applicators. This kit contains Fluoride.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
Yes
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
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.
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FDA Product Code

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Product Code Product Code Name
DYH Adhesive, Bracket And Tooth Conditioner, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
No CLOSE

Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

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Storage and Handling
Special Storage Condition, Specify: Store refrigerated (2-8 degrees C). Avoid excessive heat. Allow product to reach room temperature prior to use.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

9f6bbe63-0222-494b-b2a4-be60005a9649
March 29, 2018
2
August 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

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Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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