EsBond 101-0501

GUDID 08809262955415

5th Generation Bonding. Light Cured, single bottle application bonding system.

Spident Co., Ltd.

Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set Dentine bonding agent/set
Primary Device ID08809262955415
NIH Device Record Key200b3ebf-f00a-4479-a76b-270843aa3c04
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsBond
Version Model Number101-0501
Catalog Number101-0501
Company DUNS689370711
Company NameSpident Co., Ltd.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Customer Support Contacts

Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com
Phone201-944-0511
EmailSpident.usa@gmail.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100000202309208 [Package]
Package: [150 Units]
Discontinued: 2023-09-20
In Commercial Distribution
GS100202202110062 [Package]
Package: [200 Units]
In Commercial Distribution
GS108809262955415 [Primary]
GS120210305180053 [Package]
Package: [100 Units]
Discontinued: 2019-05-16
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

KLEAgent, Tooth Bonding, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2019-05-17
Device Publish Date2017-02-20

Devices Manufactured by Spident Co., Ltd.

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08809262954524 - Base It2021-01-26 Light-cured base/liner containing calcium hydroxyapatite in urethane methacrylate oligomer.
20200623170027 - EsFlow LV A2 Syringe2021-01-26
20200723170026 - EsFlow LV A3 Syringe2021-01-26
00210205180012 - EsCom100 A4 Syringe2021-01-26 Nano-hybrid universal composite resin for posterior and anterior restorations.
20210205180023 - EsCom 100 B1 Syringe2021-01-26
08809262955576 - EsCom 100 A1 Capsules2021-01-26
20200523170066 - EsCom 100 A3.5 Capsules2021-01-26
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