EsCom100 A3.5 Syringe 101-0704

GUDID 08809262955248

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

Spident Co., Ltd.

Dental composite resin
Primary Device ID08809262955248
NIH Device Record Key7fa207a7-99d0-45dc-9d61-029c191f55ad
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsCom100 A3.5 Syringe
Version Model Number101-0704
Catalog Number101-0704
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
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
GS100015202309141 [Package]
Package: [20 Units]
Discontinued: 2023-09-14
In Commercial Distribution
GS100202201110032 [Package]
Package: [83 Units]
In Commercial Distribution
GS100202201110049 [Package]
Package: [17 Units]
In Commercial Distribution
GS108809262955248 [Primary]
GS120210305180046 [Package]
Package: [50 Units]
Discontinued: 2019-05-16
Not in Commercial Distribution

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

Devices Manufactured by Spident Co., Ltd.

08809262950007 - EsFlow PLUS2025-08-08 EsFlow PLUS A1 2.5g x 2sy
08809262950014 - EsFlow PLUS2025-08-08 EsFlow PLUS A2 2.5g x 2sy
08809262950021 - EsFlow PLUS2025-08-08 EsFlow PLUS A3 2.5g x 2sy
08809262950038 - EsFlow PLUS2025-08-08 EsFlow PLUS A3.5 2.5g x 2sy
08809262950045 - EsFlow PLUS2025-08-08 EsFlow PLUS B1 2.5g x 2sy
08809262950052 - EsFlow PLUS2025-08-08 EsFlow PLUS B2 2.5g x 2sy
08809262950069 - EsFlow PLUS2025-08-08 EsFlow PLUS AO 2.5g x 2sy
08809262950076 - EsFlow PLUS2025-08-08 EsFlow PLUS AE 2.5g x 2sy
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