DEVICE: Self Etching primer (D798SEPC0)

Device Identifier (DI) Information

Self Etching primer
SEPC
Not in Commercial Distribution
SEPC
RELIANCE ORTHODONTIC PRODUCTS INC
D798SEPC0
HIBCC
February 15, 2018
1
113170088 *Terms of Use
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 College Kit – 1x S.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW 50 x Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD
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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 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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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

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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 Record Status

7a8ff8d1-6a24-4f8b-8502-9287a3ae33a8
March 29, 2018
2
September 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)

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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

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