FDA.report

ArgenZ HT+ 98x25 ML D4B

Primary DI
D818130403
Brand
ArgenZ HT+ 98x25 ML D4B
Company
ARGEN CORPORATION, THE
Model
130403
Catalog number
130403
Device description
Dental porcelain/ceramic restoration kit
Published
2022-03-14
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
true

Related Records

Product Codes

CodeName
EIHPOWDER, PORCELAIN

Product Code Classifications

CodeDeviceSpecialtyClass
EIHPowder, PorcelainDental2

Premarket Submissions

SubmissionSupplement
K190079000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K190079000ArgenZ HT+The Argen Corporation2019-04-12EIH

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
D818130403PrimaryHIBCC0

GMDN Terms

TermDefinition
Dental porcelain/ceramic restoration kitA collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.

Sterilization Methods

Method

Contacts

PhoneEmail
+1(858) 455-7900pcascone@argen.com

Regulatory Flags

DUNS number
103095543
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company

Primary DIBrandModelCatalogPublished
D818138360Zimax ClassicUltra 98x121383601383602026-02-11
D818137839ArgenZ GT 98x12 A11378391378392026-01-15
D818137840ArgenZ GT 98x12 A21378401378402026-01-15
D818137841ArgenZ GT 98x12 A31378411378412026-01-15
D818137849ArgenZ GT 98x16 A11378491378492026-01-15
D818137850ArgenZ GT 98x16 A21378501378502026-01-15
D818137851ArgenZ GT 98x16 A31378511378512026-01-15
D818137859ArgenZ GT 98x20 A11378591378592026-01-15
D818137860ArgenZ GT 98x20 A21378601378602026-01-15
D818137861ArgenZ GT 98x20 A31378611378612026-01-15
D818137864ArgenZ GT 98x25 A11378641378642026-01-15
D818137865ArgenZ GT 98x25 A21378651378652026-01-15
D818137866ArgenZ GT 98x25 A31378661378662026-01-15
D818137874ArgenZ GT 98x12 B11378741378742026-01-15
D818137877ArgenZ GT 98x12 B41378771378772026-01-15
D818137882ArgenZ GT 98x16 B11378821378822026-01-15
D818137885ArgenZ GT 98x16 B41378851378852026-01-15
D818137890ArgenZ GT 98x20 B11378901378902026-01-15
D818137893ArgenZ GT 98x20 B41378931378932026-01-15
D818137894ArgenZ GT 98x25 B11378941378942026-01-15

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
06941382286740Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286757Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286764Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286771Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286788Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286795Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286801Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286818Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286825Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286832Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286849Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286856Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286863Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286870Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286887Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286894Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286900Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286917Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286924Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286931Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286948Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286955Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286962Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286979Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286986Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382286993Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287006Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287013Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287020Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20
06941382287037Gradual Dental Zirconia BlankLiaoning Upcera Co.,Ltd.EIH2026-03-20