DEVICE: GC Ortho Etching Gel (E53590140000001)

Device Identifier (DI) Information

GC Ortho Etching Gel
90-1400-0000
In Commercial Distribution
90-1400-0000
Gc Orthodontics America Inc.
E53590140000001
HIBCC

1
063167128 *Terms of Use
GC Ortho Etching Gel 2 syringe pack
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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
DYH ADHESIVE, BRACKET AND TOOTH CONDITIONER, 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
Storage Environment Temperature: between 39 and 77 Degrees Fahrenheit
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Clinically Relevant Size

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

55769731-83b9-44fe-a5d4-20a6e96a991f
March 29, 2018
2
August 01, 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
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
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

[?]
+1(708)897-8859
GCOAInfo@gcorthodontics.com
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