DEVICE: Phase II (D798DCJF0)

Device Identifier (DI) Information

Phase II
DCJF
Not in Commercial Distribution
DCJF
RELIANCE ORTHODONTIC PRODUCTS INC
D798DCJF0
HIBCC
December 21, 2017
1
113170088 *Terms of Use
PhaseII® Dual Cure is intended for use as an orthodontic adhesive for direct and indirect bonding. Phase II® DUAL CURE combines the best of both chemical and light cure polymerization. The chemical cure working time is 4 minutes to allow several brackets to be set and positioned from one mix. An initial set can be immediately achieved by light curing from any angle for 10 seconds. This will prevent the loss of bond strength due to saliva contamination. This unique dual cure process allows complete polymerization under metal brackets where the light does not reach. When an immediate final set is desired, simply light cure a metal or ceramic bracket for 30 seconds. This kit contains paste in 18g jars A & B and 2 X 3cc Sealant Resin and 1 9g etchant. 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
Dental restorative material applicator A hand-held manual dental instrument in the form of a rod of flexible metal or synthetic polymer material intended to be used for the application of a dental restorative material (e.g., amalgam, resin) to a patient?s tooth/teeth. It may be brush-like in design. This is a single-use device.
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FDA Product Code

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Product Code Product Code Name
EBF Material, Tooth Shade, Resin
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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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 at room temperature (15-30 Degrees C) Protect from Light
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

4dae4b93-acb0-4d4f-a3be-d2bdf94888bd
March 29, 2018
2
August 08, 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

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6307734009
paulgropi@aol.com
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