AnyOne External Fixture EF4007C

GUDID 08806388213139

AnyOne External Implant System

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece
Primary Device ID08806388213139
NIH Device Record Keye5ac8026-10f3-4b89-a026-37c5ba309f80
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyOne External Fixture
Version Model NumberEF4007
Catalog NumberEF4007C
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 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
GS108806388213139 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DZEImplant, Endosseous, Root-Form

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-11-16
Device Publish Date2023-11-08

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08806388213931AnyOne External Implant System
08806388213917AnyOne External Implant System
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08806388213856AnyOne External Implant System
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08806388213634AnyOne External Implant System
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08806388213016AnyOne External Implant System
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