Zimax ClassicUltra 98x12 138360

GUDID D818138360

Dental ceramic materials for fabrication of dental restorations

ARGEN CORPORATION, THE

Dental appliance fabrication material, ceramic
Primary Device IDD818138360
NIH Device Record Key6eaa3eb3-9723-4bcd-8a23-f0219692fd34
Commercial Distribution StatusIn Commercial Distribution
Brand NameZimax ClassicUltra 98x12
Version Model Number138360
Catalog Number138360
Company DUNS103095543
Company NameARGEN CORPORATION, THE
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 Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com
Phone1-800-255-5524
Emailcustomersuccess@argen.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCD818138360 [Primary]

FDA Product Code

EIHPowder, Porcelain

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-19
Device Publish Date2026-02-11

Devices Manufactured by ARGEN CORPORATION, THE

D818138360 - Zimax ClassicUltra 98x122026-02-19Dental ceramic materials for fabrication of dental restorations
D818138360 - Zimax ClassicUltra 98x122026-02-19 Dental ceramic materials for fabrication of dental restorations
D818137839 - ArgenZ GT 98x12 A12026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137840 - ArgenZ GT 98x12 A22026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137841 - ArgenZ GT 98x12 A32026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137849 - ArgenZ GT 98x16 A12026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137850 - ArgenZ GT 98x16 A22026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137851 - ArgenZ GT 98x16 A32026-01-23 Dental ceramic materials for fabrication of dental restorations
D818137859 - ArgenZ GT 98x20 A12026-01-23 Dental ceramic materials for fabrication of dental restorations

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