GlasIonomer F 1142

GUDID E23511420

GLAS II PWD/YLLW

SHOFU DENTAL CORPORATION

Glass ionomer dental cement
Primary Device IDE23511420
NIH Device Record Key72a6de9c-19aa-4bf3-9e8d-9dd6071449e1
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlasIonomer F
Version Model Number1142
Catalog Number1142
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
HIBCCE23511420 [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 [GlasIonomer F ]

E23511440Discountinued
E23511430GLAS II PWD/GRAY
E23511420GLAS II PWD/YLLW
E23511410GLAS II PWD/UNIV
E23511400GLAS II LIQUID
E23511380GLASIONOMER VARNISH
E23511340Discountinued
E23511330GLAS II KIT/1-GRAY
E23511320GLAS II KIT/1-YLLW
E23511310GLAS II KIT/1 UNIV
E23511300GLAS II KIT/4-COLOR

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