DEVICE: G2-Bond Universal (D0470136521)

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Device Record History
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Device Identifier (DI) Information
G2-Bond Universal
013652
In Commercial Distribution
013652
Gc America Inc.
D0470136521
HIBCC

1
005473608 *Terms of Use
G2-Bond Universal 2-Bond Refill 5ml
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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?
34782 Dentine bonding agent/set
A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.
Active false
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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 [?]
K200682 000
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 39.2 and 77 Degrees Fahrenheit
Storage Environment Temperature: between 4 and 25 Degrees Celsius
Special Storage Condition, Specify: If not in use for a prolonged period of time, store in refrigerator.
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
bacd6027-9361-43d9-bf8e-37c97ef17edd
January 21, 2026
3
July 21, 2021
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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)597-0900
customerservice@gcamerica.com
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