EsCom 100 B1 Syringe 101-0709

GUDID 20210205180023

Spident Co., Ltd.

Dental composite resin
Primary Device ID20210205180023
NIH Device Record Key3381ebb3-20ae-4104-8da9-8287256bcfca
Commercial Distribution StatusIn Commercial Distribution
Brand NameEsCom 100 B1 Syringe
Version Model Number101-0709
Catalog Number101-0709
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108809262955262 [Primary]
GS120210205180023 [Package]
Contains: 08809262955262
Package: [20 Units]
Discontinued: 2021-01-25
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 Number2
Public Version Date2021-01-26
Device Publish Date2018-08-23

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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