DEVICE: Flow Tain (D798FTLV0)

Device Identifier (DI) Information

Flow Tain
FTLV
In Commercial Distribution
FTLV
RELIANCE ORTHODONTIC PRODUCTS INC
D798FTLV0
HIBCC

1
113170088 *Terms of Use
FlowTain™ L.V. (Low Viscosity) is a flowable, light cure adhesive intended to be used for indirect bonding of orthodontic brackets. 1.5g syringe of Flow Tain Low Viscosity and 10 (22 gauge) tips
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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
Dental composite resin A non-sterile substance intended for professional use as a dental luting agent, liner, base, pulp-capping material, pit/fissure sealant, and/or direct dental restorative material, whereby the majority of the setting reaction is based on the self-, light-, or dual-cured polymerization of a dimethacrylate resin [e.g., polymethylmethacrylate (PMMA), polyurethane, or bisphenol-A-diglycidylether methacrylate (Bis-GMA)]; it includes some additional fillers/components (e.g., glass-based, quartz, or ceramic). It may be preloaded into a syringe, and dedicated disposable devices associated with application may be included. 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 [?]
K083051 000
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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 C).
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status

51cacce2-1c43-441e-83ce-c2765bcfe026
July 06, 2018
3
August 14, 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

[?]
630-773-4009
paulgropi@aol.com
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