DEVICE: Gel Etchant (D798EGSS0)
Device Identifier (DI) Information
Gel Etchant
EGSS
In Commercial Distribution
EGSS
RELIANCE ORTHODONTIC PRODUCTS INC
EGSS
In Commercial Distribution
EGSS
RELIANCE ORTHODONTIC PRODUCTS INC
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.
Device Characteristics
Labeling does not contain MRI Safety Information | |
No | |
No | |
No | |
Yes | |
No | |
No | |
No | |
No |
GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
---|---|---|---|---|
36153 | 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.
|
Active | false |
FDA Product Code
[?]Product Code | Product Code Name |
---|---|
KLE | Agent, Tooth Bonding, Resin |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
---|---|
Premarket Submission Number Not Available/Not Released |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Special Storage Condition, Specify: Storage at room temperature (15-30 Degrees C) |
Clinically Relevant Size
[?]Size Type Text |
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No Device Sizes |
Device Record Status
3f5102d3-8d6e-4df4-be62-5e0114b456b7
October 29, 2018
4
September 03, 2016
October 29, 2018
4
September 03, 2016
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 |
Secondary DI
[?]Issuing Agency [?] | Secondary DI Number |
---|---|
No Secondary DIs found |
Unit of Use DI
[?]
Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
6307734009
paulgropi@aol.com
paulgropi@aol.com