DEVICE: EsBond (08809262955415)

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Device Record History
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Device Identifier (DI) Information
EsBond
101-0501
In Commercial Distribution
101-0501
Spident Co., Ltd.
08809262955415
GS1

1
689370711 *Terms of Use
5th Generation Bonding. Light Cured, single bottle application bonding system.
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
No
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 [?]
K120767 000
No CLOSE

Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
200b3ebf-f00a-4479-a76b-270843aa3c04
February 16, 2024
9
February 20, 2017
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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
20210305180053 100 08809262955415 2019-05-16 Not in Commercial Distribution
00202202110062 200 08809262955415 2021-01-25 Not in Commercial Distribution
00000202309208 150 08809262955415 2023-09-20 Not in Commercial Distribution
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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

[?]
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
Yes
No CLOSE

Customer Contact

[?]
201-944-0511
Spident.usa@gmail.com
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