Pre-Milled Blank Screw

GUDID 08800055700113

ARUM DENTISTRY Co., Ltd.

Dental implant suprastructure, permanent, preformed
Primary Device ID08800055700113
NIH Device Record Key0e7b4e1c-b916-41f3-8609-b984aab08510
Commercial Distribution StatusIn Commercial Distribution
Brand NamePre-Milled Blank Screw
Version Model NumberCSTO001
Company DUNS557821945
Company NameARUM DENTISTRY Co., Ltd.
Device Count10
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
GS108800055700069 [Unit of Use]
GS108800055700113 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

Dry Heat Sterilization;Moist Heat or Steam Sterilization


[08800055700113]

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 Screw]

08800055700120CSTO002
08800055700113CSTO001

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