GlasIonomer FX-II 3273

GUDID E23532730

Glasionomer FX-II B2 Cement

SHOFU DENTAL CORPORATION

Glass ionomer dental cement
Primary Device IDE23532730
NIH Device Record Key6383de27-d025-430e-af65-d2a450bc70b7
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlasIonomer FX-II
Version Model Number3273
Catalog Number3273
Company DUNS054618202
Company NameSHOFU DENTAL CORPORATION
Device Count50
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
HIBCCE23532730 [Primary]
HIBCCE235327301 [Unit of Use]

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 Date2016-09-23

On-Brand Devices [GlasIonomer FX-II]

E235FXIICSA30FX-II A3 Cement Capsule Sample Kit. Contains DI's: E23532710
E235FXIICSA20FX-II A2 Cement Capsule Sample Kit. Contains DI's: E23532700
E23532730Glasionomer FX-II B2 Cement
E23532720Glasionomer FX-II A3.5 Cement
E23532710Glasionomer FX-II A3 Cement
E23532700Glasionomer FX-II A2 Cement

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