DMAX / Confident / Chang's / CAMeleon Coloring Liquid

GUDID 08809542035684

DMAX Co.,Ltd.

Dental appliance fabrication material, ceramic
Primary Device ID08809542035684
NIH Device Record Key3b46faa3-bcfc-49f2-9d9e-366f9cc7093c
Commercial Distribution StatusIn Commercial Distribution
Brand NameDMAX / Confident / Chang's / CAMeleon Coloring Liquid
Version Model NumberB2-40ml
Company DUNS557798558
Company NameDMAX 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
GS108809542035684 [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 Date2019-06-03
Device Publish Date2019-05-24