DMAX / Confident / Chang's / CAMeleon Coloring Liquid

GUDID 08809542037053

DMAX Co.,Ltd.

Dental appliance fabrication material, ceramic
Primary Device ID08809542037053
NIH Device Record Key6a0cc430-487c-4f61-b96b-09fb14311495
Commercial Distribution StatusIn Commercial Distribution
Brand NameDMAX / Confident / Chang's / CAMeleon Coloring Liquid
Version Model Number2M2-100ml
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
GS108809542037053 [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