DEVICE: Custom I.Q. (D798CIQB0)

Device Identifier (DI) Information

Custom I.Q.
CIQB
In Commercial Distribution
CIQB
RELIANCE ORTHODONTIC PRODUCTS INC
D798CIQB0
HIBCC

1
113170088 *Terms of Use
INDICATIONS FOR USE: Custom IQ™ is intended for use as a chair-side, fast set, no mix chemical cure bonding resin for custom base indirect bonding. This is Part B of the two part system
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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
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 includes a resin-based bonding agent and may also include a primer and/or etching solution (as a single formulation or as part of a set); composite resin is not included. It may also be used as an enamel bonding material. After application, this device cannot be reused.
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FDA Product Code

[?]
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 [?]
K880791 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: TEMPERATURE LIMITATION: Store refrigerated (2-8 degrees C.) Do not expose materials to elevated temperatures.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

da3b9bcd-3dfe-4688-9e43-a4eb4228c3ec
July 06, 2018
3
July 25, 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)

[?]
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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