Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank

GUDID 06975018580087

Zirdent New Material Co.,Ltd

Dental appliance fabrication material, combination-material
Primary Device ID06975018580087
NIH Device Record Keycaeef783-8b91-4c2b-bd62-7074cad2413c
Commercial Distribution StatusIn Commercial Distribution
Brand NameZirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Version Model Number3D-pro-ML
Company DUNS699451090
Company NameZirdent New Material Co.,Ltd
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 Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS106975018580087 [Primary]
GS116975018580084 [Package]
Package: [40 Units]
In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

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 Date2022-01-17
Device Publish Date2022-01-08

On-Brand Devices [Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank]

16975018580114UT-ML
16975018580107UT-C
06975018580094UT
069750185800873D-pro-ML
06975018580070SHT-ML
06975018580063SHT-C
06975018580056SHT-C
06975018580049ST-ML
06975018580025ST-C
06975018580018ST
06975018580001HT plus
16975018580121SHT

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.