FDA.report

ArgenZ HT+ 98x14 ML C1B

Primary DI
D818130321
Brand
ArgenZ HT+ 98x14 ML C1B
Company
ARGEN CORPORATION, THE
Model
130321
Catalog number
130321
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
D818130321PrimaryHIBCC0

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

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