ArgenZ HT+ 98x14 A1B
| Catalog Number: | 130108 |
|---|---|
| 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: | 8a63eb71-887e-4ae6-bc67-e07920c88833 |
| 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: | 130108 |
| 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
D818130108
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