DEVICE: Gel Etchant (D798EGSS0)

Device Identifier (DI) Information

Gel Etchant
EGSS
In Commercial Distribution
EGSS
RELIANCE ORTHODONTIC PRODUCTS INC
D798EGSS0
HIBCC

1
113170088 *Terms of Use
Gel Etchant is intended for use in the etching of enamel surface prior to bonding. This is a 6.5gm push syringe of gel etchant with 20 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 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

[?]
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

[?]
Storage and Handling
Special Storage Condition, Specify: Storage at room temperature (15-30 Degrees C)
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

3f5102d3-8d6e-4df4-be62-5e0114b456b7
October 29, 2018
4
September 03, 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
D798EGSS1 5 D798EGSS0 In Commercial Distribution Bag
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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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