GlasIonomer FX-II 3272

GUDID E23532720

Glasionomer FX-II A3.5 Cement

SHOFU DENTAL CORPORATION

Glass ionomer dental cement
Primary Device IDE23532720
NIH Device Record Key3fe17726-dbe4-44ae-ad26-00aba123d05a
Commercial Distribution StatusIn Commercial Distribution
Brand NameGlasIonomer FX-II
Version Model Number3272
Catalog Number3272
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
HIBCCE23532720 [Primary]
HIBCCE235327201 [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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