Chang's DA-vich

GUDID 08800118622840

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118622840
NIH Device Record Key3955de55-429f-43e0-8135-ffc28b3fbf33
Commercial Distribution StatusIn Commercial Distribution
Brand NameChang's DA-vich
Version Model NumberDeep Dentin C Dark 40ml
Company DUNS694821663
Company NameU&C International 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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800118622840 [Primary]

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 Date2022-03-17
Device Publish Date2022-03-09