DEVICE: Self Etching primer (D798SEPPRO0)

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Device Identifier (DI) Information

Self Etching primer
SEPPRO
SEPPRO
RELIANCE ORTHODONTIC PRODUCTS INC
D798SEPPRO0
HIBCC
1
The Reliance S.E.P.™ is a self etching primer Kit intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P Starter Kit – Ref# SEPPROS.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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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 etching solution An acid solution, in liquid or gel form, intended to be used to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant. After application, this device cannot be reused.
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FDA Product Code

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Product Code Product Code Name
KLE Agent, Tooth Bonding, Resin
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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: TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C). Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light.
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Status

In Commercial Distribution
August 01, 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
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No CLOSE

Customer Contact

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630-773-4009
paulgropi@aol.com
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