EsFlow A3.5 Syringe 101-0804

GUDID 08809262954746

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

Spident Co., Ltd.

Dental composite resin
Primary Device ID08809262954746
NIH Device Record Key826c8d17-e332-402a-aa44-d72527b1e79f
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsFlow A3.5 Syringe
Version Model Number101-0804
Catalog Number101-0804
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
GS100000202308126 [Package]
Package: [45 Units]
Discontinued: 2023-08-12
In Commercial Distribution
GS108809262954746 [Primary]
GS120191201160045 [Package]
Package: [30 Units]
Discontinued: 2019-08-31
In Commercial Distribution
GS120220111180048 [Package]
Package: [60 Units]
In Commercial Distribution

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 Number5
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
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.