I-SiL Jumbo Regular Body 102-0601

GUDID 08809262959802

Spident Co., Ltd.

Silicone dental impression material
Primary Device ID08809262959802
NIH Device Record Key8bb153f8-1d38-4e36-82d9-feb33913cc79
Commercial Distribution StatusIn Commercial Distribution
Brand NameI-SiL Jumbo Regular Body
Version Model Number102-0601
Catalog Number102-0601
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
GS100020082209214 [Package]
Package: [30 Units]
Discontinued: 2022-09-21
In Commercial Distribution
GS102018122616083 [Package]
Package: [200 Units]
Discontinued: 2021-01-25
Not in Commercial Distribution
GS108809262959802 [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 Number5
Public Version Date2021-01-26
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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