Octa Abutment IOA200

GUDID 08806388222063

Exfeel Internal Octa

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08806388222063
NIH Device Record Key5bf11d85-9994-4697-9a68-1b2be1b7a69a
Commercial Distribution StatusIn Commercial Distribution
Brand NameOcta Abutment
Version Model NumberIOA200
Catalog NumberIOA200
Company DUNS687388178
Company NameMegagen Implant 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 Numbertrue
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
GS108806388222063 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


[08806388222063]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-07-09
Device Publish Date2021-07-01

On-Brand Devices [Octa Abutment]

08806388230020AnyOne Internal Ø5.8/ C=5.5
08806388230013AnyOne Internal Ø5.8/ C=4.5
08806388230006AnyOne Internal Ø5.8/ C=3.5
08806388229994AnyOne Internal Ø5.8/ C=2.5
08806388229987AnyOne Internal Ø5.8/ C=1.5
08806388229970AnyOne Internal Ø5.8/ C=1
08806388229963AnyOne Internal Ø4.8/ C=5.5
08806388229956AnyOne Internal Ø4.8/ C=4.5
08806388229949AnyOne Internal Ø4.8/ C=3.5
08806388229932AnyOne Internal Ø4.8/ C=2.5
08806388229925AnyOne Internal Ø4.8/ C=1.5
08806388229918AnyOne Internal Ø4.8/ C=1
08806388229901AnyOne Internal Ø3.8/ C=5.5
08806388229895AnyOne Internal Ø3.8/ C=4.5
08806388229888AnyOne Internal Ø3.8/ C=3.5
08806388229871AnyOne Internal Ø3.8/ C=2.5
08806388229864AnyOne Internal Ø3.8/ C=1.5
08806388229857AnyOne Internal Ø3.8/ C=1
08806388203314AnyRidge Internal Ø4.8/ C=5
08806388203307AnyRidge Internal Ø4.8/ C=4
08806388203291AnyRidge Internal Ø4.8/ C=3
08806388203284AnyRidge Internal Ø4.8/ C=2
08806388222063Exfeel Internal Octa

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