Multi-unit Abutment Package SKAENN3000H

GUDID 08806388256167

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 Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed
Primary Device ID08806388256167
NIH Device Record Key9dc44d12-72dd-4a9a-a53f-ba2e78f9a85f
Commercial Distribution StatusIn Commercial Distribution
Brand NameMulti-unit Abutment Package
Version Model NumberSKAENN3000H
Catalog NumberSKAENN3000H
Company DUNS687388178
Company NameMegagen Implant Co. Ltd
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusMR Conditional
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
GS108806388256167 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


[08806388256167]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-20
Device Publish Date2023-11-10

On-Brand Devices [Multi-unit Abutment Package]

08809708759119C=4.5/ A=17/ Non-Hex
08806388278060C=4.5/ A=30/ Non-Octa/ RC
08806388278053C=3.5/ A=30/ Non-Octa/ RC
08806388278046C=4.5/ A=17/ Non-Octa/ RC
08806388278039C=3.5/ A=17/ Non-Octa/ RC
08806388278022C=2.5/ A=17/ Non-Octa/ RC
08806388278015C=4.5/ A=30/ Octa/ RC
08806388278008C=3.5/ A=30/ Octa/ RC
08806388277995C=4.5/ A=17/ Octa/ RC
08806388277988C=3.5/ A=17/ Octa/ RC
08806388277971C=2.5/ A=17/ Octa/ RC
08806388277964C=4.5/ A=30/ Non-Octa/ NC
08806388277957C=3.5/ A=30/ Non-Octa/ NC
08806388277940C=4.5/ A=17/ Non-Octa/ NC
08806388277933C=3.5/ A=17/ Non-Octa/ NC
08806388277926C=2.5/ A=17/ Non-Octa/ NC
08806388277919C=4.5/ A=30/ Octa/ NC
08806388277902C=3.5/ A=30/ Octa/ NC
08806388277896C=4.5/ A=17/ Octa/ NC
08806388277889C=3.5/ A=17/ Octa/ NC
08806388277872C=2.5/ A=17/ Octa/ NC
08806388277865C=4.5/ Straight/ RC
08806388277858C=3.5/ Straight/ RC
08806388277841C=2.5/ Straight/ RC
08806388277834C=1.5/ Straight/ RC
08806388277827C=4.5/ Straight/ NC
08806388277810C=3.5/ Straight/ NC
08806388277803C=2.5/ Straight/ NC
08806388277797C=1.5/ Straight/ NC
08806388277780C=4.5/ A=30/ Non-Octa/ RC
08806388277773C=3.5/ A=30/ Non-Octa/ RC
08806388277766C=4.5/ A=17/ Non-Octa/ RC
08806388277759C=3.5/ A=17/ Non-Octa/ RC
08806388277742C=2.5/ A=17/ Non-Octa/ RC
08806388277735C=4.5/ A=30/ Octa/ RC
08806388277728C=3.5/ A=30/ Octa/ RC
08806388277711C=4.5/ A=17/ Octa/ RC
08806388277704C=3.5/ A=17/ Octa/ RC
08806388277698C=2.5/ A=17/ Octa/ RC
08806388277681C=4.5/ A=30/ Non-Octa/ NC
08806388277674C=3.5/ A=30/ Non-Octa/ NC
08806388277667C=4.5/ A=17/ Non-Octa/ NC
08806388277650C=3.5/ A=17/ Non-Octa/ NC
08806388277643C=2.5/ A=17/ Non-Octa/ NC
08806388277636C=4.5/ A=30/ Octa/ NC
08806388277629C=3.5/ A=30/ Octa/ NC
08806388277612C=4.5/ A=17/ Octa/ NC
08806388277605C=3.5/ A=17/ Octa/ NC
08806388277599C=2.5/ A=17/ Octa/ NC
08806388277582C=4.5/ Straight/ RC

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