Core It Blue 101-0302

GUDID 08809262954845

Radiopaque, dual cured composite core build up material in blue shade

Spident Co., Ltd.

Dental composite resin
Primary Device ID08809262954845
NIH Device Record Keyc8511840-82a4-4ef2-a29c-667cb6021f74
Commercial Distribution StatusIn Commercial Distribution
Brand NameCore It Blue
Version Model Number101-0302
Catalog Number101-0302
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

Device Identifiers

Device Issuing AgencyDevice ID
GS100202101110057 [Package]
Package: [10 Units]
In Commercial Distribution
GS108809262954845 [Primary]
GS120200105170125 [Package]
Package: [10 Units]
Discontinued: 2019-05-16
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 Number6
Public Version Date2019-05-17
Device Publish Date2017-02-20

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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