BASE CEMENT 1113

GUDID E23511130

GLAS BASE CMT PDR WHT

SHOFU DENTAL CORPORATION

Glass ionomer dental cement
Primary Device IDE23511130
NIH Device Record Key058c4215-adb6-4d3e-84da-9eb0edf620ee
Commercial Distribution StatusIn Commercial Distribution
Brand NameBASE CEMENT
Version Model Number1113
Catalog Number1113
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
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

Customer Support Contacts

Phone760-566-3528
Emailckaemmerlen@shofu.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCE23511130 [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 Number3
Public Version Date2018-07-06
Device Publish Date2016-09-26

On-Brand Devices [BASE CEMENT]

E23511140GLAS BASE CEMENT LIQ.
E23511130GLAS BASE CMT PDR WHT
E23511110GLAS BASE CMT PDR YEL
E23511100GLAS BASE CMT INTRO KT

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