Pre-Milled Blank

GUDID 08800055700021

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800055700021
NIH Device Record Key7ed625e5-7390-444a-8de9-05e0bb2373bc
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-Milled Blank
Version Model NumberCIHE039
Company DUNS557821945
Company NameARUM DENTISTRY 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 Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108800055700021 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHSAssay, Genotype, Hiv Drug Resistance, In Vitro

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700021]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2020-04-27
Device Publish Date2020-04-17

On-Brand Devices [Pre-Milled Blank]

08800055700052CIHE136
08800055700045CIHE135
08800055700038CIHE040
08800055700021CIHE039
08800055700014CIHE038
08800055700007CIHE037

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