ArgenZ HT+ 98x30 D3B

Catalog Number: 129929
Company Name: ARGEN CORPORATION, THE
Device Combination Product: N/A
Device Commercial Dsitribution End Date: N/A
Device Commercial Dsitribution Status: In Commercial Distribution
Device Count: 1
Device Description: Dental porcelain/ceramic restoration kit
Device hctp: N/A
Device kit: N/A
Device Publish Date: 2022-03-14
Device Record Status: Published
Direct Market Exempt: N/A
Has Donation ID number? N/A
DUNS Number: 103095543
Has Expiration Date? N/A
Is Labelled as NRL: N/A
Is Labelled As No NRL: N/A
Has Lot Batch Number: true
Has Manufacutring Date: N/A
MRI Safety Status: Labeling does not contain MRI Safety Information
Is OTC? N/A
Is Devic Premarket Exempt: N/A
Public Device Record Key: 4b1e21d8-1e53-4257-828b-02c063d206d2
Public Version Date: 2022-03-22
Public Version Number: 1
Public Version Status: New
Is Rx? true
Has Serial Number? N/A
Is Single Use: true
Version Model Number: 129929
Adress: Phone:+1(858) 455-7900
Extension:
Email: pcascone@argen.com
Storage Condition
Storage Handling Type
Storage Handling High
Storage Handling Low
Storage Handling Special Condition
N/A
N/A
N/A
N/A
GMDN Terms
GMDN Name
GMDN Term Definition
Dental porcelain/ceramic restoration kit
A 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.
Identifiers
Device ID
Device ID Type
Issuing Agency
Contains DI No
Pkg Qty
Pkg Discontinue dt
Pkg Status
Pkg Type
D818129929
Primary
HIBCC
Sterilization
Is Device Sterile
Is Steriliztion Prior Use
Sterilization Method
false
false
Product Codes
Product Code
Product Code Name
EIH
POWDER, PORCELAIN
Pre Market Submisison
Submission Number
Supplement Number
K190079
000