TiGEN Abutment MITN1020T

GUDID 08806388227945

MiNi Internal Implant System Ø10/ L=20

Megagen Implant Co. Ltd

Dental implant suprastructure, permanent, preformed
Primary Device ID08806388227945
NIH Device Record Key4caff9ad-1ac3-4d7a-a572-d392805e00bc
Commercial Distribution StatusIn Commercial Distribution
Brand NameTiGEN Abutment
Version Model NumberMITN1020
Catalog NumberMITN1020T
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
GS108806388227945 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usetrue
Device Is Sterilefalse

[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


[08806388227945]

Moist Heat or Steam Sterilization


Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-20
Device Publish Date2023-06-12

On-Brand Devices [TiGEN Abutment]

08809708759331XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core3.3
08809708759324XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core3.3
08809708759317XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core4
08809708759300XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core4
08809708759294XPEED AnyRidge Internal Implant System Ø12/ L=20/ Non-Hex/ Core4.8
08809708759287XPEED AnyRidge Internal Implant System Ø12/ L=20/ Core4.8
08806388267149XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4.8
08806388267132XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4.8
08806388267125XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4
08806388267118XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4
08806388267101XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core3.3
08806388267095XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core3.3
08806388267088Common Ø10/ L=20/ Wide/ Non-Octa
08806388267071Common Ø10/ L=20/ Wide
08806388267064Common Ø10/ L=20/ Regular/ Non-Octa
08806388267057Common Ø10/ L=20/ Regular
08806388267040Common Ø10/ L=20/ Small/ Non-Octa
08806388267033Common Ø10/ L=20/ Small
08806388267026AnyOne Internal & ST Implant System Ø10/ L=20/ Non-Hex
08806388267019AnyOne Internal & ST Implant System Ø10/ L=20
08806388267002XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex
08806388266999XPEED AnyRidge Internal Implant System Ø10/ L=20
08806388266944XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4.8
08806388266937XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4.8
08806388266920XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core4
08806388266913XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core4
08806388266906XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex/ Core3.3
08806388266890XPEED AnyRidge Internal Implant System Ø10/ L=20/ Core3.3
08806388266883Common Ø10/ L=20/ Wide/ Non-Octa
08806388266876Common Ø10/ L=20/ Wide
08806388266869Common Ø10/ L=20/ Regular/ Non-Octa
08806388266852Common Ø10/ L=20/ Regular
08806388266845Common Ø10/ L=20/ Small/ Non-Octa
08806388266838Common Ø10/ L=20/ Small
08806388266821AnyOne Internal & ST Implant System Ø10/ L=20/ Non-Hex
08806388266814AnyOne Internal & ST Implant System Ø10/ L=20
08806388266807XPEED AnyRidge Internal Implant System Ø10/ L=20/ Non-Hex
08806388266791XPEED AnyRidge Internal Implant System Ø10/ L=20
08806388261208BLUEDIAMOND Implant System Ø12/ L=20/ RC
08806388261192BLUEDIAMOND Implant System Ø10/ L=20/ RC
08806388261185BLUEDIAMOND Implant System Ø12/ L=20/ NC
08806388261178BLUEDIAMOND Implant System Ø10/ L=20/ NC
08806388260935BLUEDIAMOND Implant System Ø12/ L=20/ RC
08806388260928BLUEDIAMOND Implant System Ø10/ L=20/ RC
08806388260911BLUEDIAMOND Implant System Ø12/ L=20/ NC
08806388260904BLUEDIAMOND Implant System Ø10/ L=20/ NC
08806388245710MiNi Internal Implant System Ø10/ L=20/ Non-Hex
08806388245703MiNi Internal Implant System Ø10/ L=20
08806388245697Common Ø12/ L=20/ Wide/ Non-Octa
08806388245680Common Ø12/ L=20/ Wide

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