Everest / Megabio Rainbow

GUDID 08800118612070

U&C International Co.,Ltd

Dental appliance fabrication material, ceramic
Primary Device ID08800118612070
NIH Device Record Key90a9436c-30e7-41f6-8ab5-5bd088f1d18c
Commercial Distribution StatusIn Commercial Distribution
Brand NameEverest / Megabio Rainbow
Version Model NumberW ML PT D3 20
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
GS108800118612070 [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 Date2022-02-24
Device Publish Date2022-02-16

On-Brand Devices [Everest / Megabio Rainbow]

08800118606857Z ML AT A4 30
08800118606840Z ML AT A4 28
08800118606833Z ML AT A4 25
08800118606826Z ML AT A4 22
08800118606819Z ML AT A4 20
08800118606802Z ML AT A4 18
08800118606796Z ML AT A4 16
08800118606789Z ML AT A4 14
08800118606772Z ML AT A4 12
08800118606765Z ML AT A4 10
08800118606758Z ML AT A3.5 30
08800118606741Z ML AT A3.5 28
08800118606734Z ML AT A3.5 25
08800118606727Z ML AT A3.5 22
08800118606710Z ML AT A3.5 20
08800118606703Z ML AT A3.5 18
08800118606697Z ML AT A3.5 16
08800118606680Z ML AT A3.5 14
08800118606673Z ML AT A3.5 12
08800118606666Z ML AT A3.5 10
08800118606659Z ML AT A3 30
08800118606642Z ML AT A3 28
08800118606635Z ML AT A3 25
08800118606628Z ML AT A3 22
08800118606611Z ML AT A3 20
08800118606604Z ML AT A3 18
08800118606598Z ML AT A3 16
08800118606581Z ML AT A3 14
08800118606574Z ML AT A3 12
08800118606567Z ML AT A3 10
08800118606550Z ML AT A2 30
08800118606543Z ML AT A2 28
08800118606536Z ML AT A2 25
08800118606529Z ML AT A2 22
08800118606512Z ML AT A2 20
08800118606505Z ML AT A2 18
08800118606499Z ML AT A2 16
08800118606482Z ML AT A2 14
08800118606475Z ML AT A2 12
08800118606468Z ML AT A2 10
08800118606451Z ML AT A1 30
08800118606444Z ML AT A1 28
08800118606437Z ML AT A1 25
08800118606420Z ML AT A1 22
08800118606413Z ML AT A1 20
08800118606406Z ML AT A1 18
08800118606390Z ML AT A1 16
08800118606383Z ML AT A1 14
08800118606376Z ML AT A1 12
08800118606369Z ML AT A1 10
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