Vintage AL/ZR 8011

GUDID E23580110

VINTAGE AL OPAQUE LINER LIQ 3m

SHOFU DENTAL CORPORATION

Dental appliance fabrication material, ceramic
Primary Device IDE23580110
NIH Device Record Keyafb87996-e34e-4bf2-ba5a-aed7c361c188
Commercial Distribution StatusIn Commercial Distribution
Brand NameVintage AL/ZR
Version Model Number8011
Catalog Number8011
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
HIBCCE23580110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2018-07-24
Device Publish Date2016-09-23

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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.