EsCom100 A4 Syringe 101-0705

GUDID 00210205180012

Nano-hybrid universal composite resin for posterior and anterior restorations.

Spident Co., Ltd.

Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin Dental composite resin
Primary Device ID00210205180012
NIH Device Record Key426d1d93-61d3-4f84-b214-a044c01fb8d5
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsCom100 A4 Syringe
Version Model Number101-0705
Catalog Number101-0705
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100000202206286 [Package]
Contains: 08809262955200
Package: [20 Units]
Discontinued: 2022-06-28
In Commercial Distribution
GS100210205180012 [Package]
Contains: 08809262955200
Package: [10 Units]
Discontinued: 2021-01-25
Not in Commercial Distribution
GS108809262955200 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EBFMaterial, Tooth Shade, Resin

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2021-01-26
Device Publish Date2018-08-23

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20200623170027 - EsFlow LV A2 Syringe2021-01-26
20200723170026 - EsFlow LV A3 Syringe2021-01-26
00210205180012 - EsCom100 A4 Syringe2021-01-26Nano-hybrid universal composite resin for posterior and anterior restorations.
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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