I-SIL Putty Fast Set

GUDID 08809262959864

Vinyl Polysiloxane Impression Material

Spident Co., Ltd.

Silicone dental impression material
Primary Device ID08809262959864
NIH Device Record Key90c10a61-b0bc-4e83-a5a5-6c322fe8b8df
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-SIL Putty Fast Set
Version Model Number102-0502
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100020070922224 [Package]
Package: [90 Units]
Discontinued: 2022-09-22
In Commercial Distribution
GS102021022819027 [Package]
Package: [216 Units]
In Commercial Distribution
GS108809262959864 [Primary]

FDA Product Code

ELWMaterial, Impression

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2019-05-17
Device Publish Date2017-02-20

Devices Manufactured by Spident Co., Ltd.

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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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