AZ Primer 3232

GUDID E23532320

AZ PRIMER

SHOFU DENTAL CORPORATION

Dental prosthesis restorative material, unfilled resin
Primary Device IDE23532320
NIH Device Record Key40268404-3c6a-4f92-acfd-40c0d21807ff
Commercial Distribution StatusIn Commercial Distribution
Brand NameAZ Primer
Version Model Number3232
Catalog Number3232
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
HIBCCE23532320 [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

Devices Manufactured by SHOFU DENTAL CORPORATION

E235P08111 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-1 5pcs
E235P08121 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-2 5pcs
E235P08131 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-A1 5pcs
E235P08141 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-A2 5pcs
E235P08151 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-BL3 5pcs
E235P08161 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g E-BL4 5pcs
E235P08201 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g HT-A1 5pcs
E235P08211 - VINTAGE PRIME PRESS2024-04-12 VINTAGE PRIME PRESS 3g HT-A2 5pcs

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