DEVICE: Phase II (D798DCSF0)

Device Identifier (DI) Information

Phase II
DCSF
Not in Commercial Distribution
DCSF
RELIANCE ORTHODONTIC PRODUCTS INC
D798DCSF0
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. This kit contains 3 X 6g Phase II Pastes A with Fluoride & B in screw syringes, 2 X 3cc Light Bond Sealant Resins and 1x 9g liquid etchant with and mixing accessories. Kit contains fluoride.
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Device Characteristics

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

GMDN

[?]

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

[?]
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
No CLOSE

Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Store at room temperature (15-30 ◦ 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

0a8f2e44-546e-4cd1-b048-ed72a4b4eae5
March 29, 2018
2
August 10, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
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)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
Yes
No
Yes
No
No CLOSE

Customer Contact

[?]
6307734009
paulgropi@aol.com
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