08806388287109 AOHM70104T

GUDID 08806388287109

AnyOne Internal & ST Implant System (M6) M/ M7/ L10/ H=4/ Hex

Megagen Implant Co. Ltd

Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use Dental implant suprastructure, temporary, preformed, single-use
Primary Device ID08806388287109
NIH Device Record Key8f6e2223-75f2-4f4a-b879-3da5bdc1ed97
Commercial Distribution StatusIn Commercial Distribution
Brand Name08806388287109
Version Model NumberAOHM70104
Catalog NumberAOHM70104T
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 Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806388287109 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

NHAAbutment, Implant, Dental, Endosseous

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-06-16
Device Publish Date2023-06-08

Devices Manufactured by Megagen Implant Co. Ltd

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08809822761937 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762002 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762019 - TiGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762101 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System
08809822762125 - ZrGEN Abutment2024-02-28 ARi ExCon Implant System

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