Estemp NE Temporary Cement 101-1012

GUDID 08809262954227

Spident Co., Ltd.

Ethoxy benzoic acid dental cement
Primary Device ID08809262954227
NIH Device Record Key61d36bb5-3124-4971-8c43-40db5ef2bcb7
Commercial Distribution StatusIn Commercial Distribution
Brand NameEstemp NE Temporary Cement
Version Model Number101-1012
Catalog Number101-1012
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
GS100000202208198 [Package]
Package: [120 Units]
Discontinued: 2022-08-11
In Commercial Distribution
GS100202102110650 [Package]
Package: [96 Units]
In Commercial Distribution
GS100202102110667 [Package]
Package: [54 Units]
In Commercial Distribution
GS108809262954227 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EMACement, Dental

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2019-05-17
Device Publish Date2018-08-23

Devices Manufactured by Spident Co., Ltd.

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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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