AnyOne External Fixture EF6508DC

GUDID 08806388213870

AnyOne External Implant System

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece
Primary Device ID08806388213870
NIH Device Record Key8db529d7-75e7-4f48-bc03-1eb7ab1a38a9
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyOne External Fixture
Version Model NumberEF6508D
Catalog NumberEF6508DC
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
GS108806388213870 [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

On-Brand Devices [AnyOne External Fixture]

08806388213955AnyOne External Implant System
08806388213931AnyOne External Implant System
08806388213917AnyOne External Implant System
08806388213894AnyOne External Implant System
08806388213870AnyOne External Implant System
08806388213856AnyOne External Implant System
08806388213832AnyOne External Implant System
08806388213818AnyOne External Implant System
08806388213795AnyOne External Implant System
08806388213771AnyOne External Implant System
08806388213757AnyOne External Implant System
08806388213733AnyOne External Implant System
08806388213719AnyOne External Implant System
08806388213696AnyOne External Implant System
08806388213672AnyOne External Implant System
08806388213658AnyOne External Implant System
08806388213634AnyOne External Implant System
08806388213610AnyOne External Implant System
08806388213597AnyOne External Implant System
08806388213573AnyOne External Implant System
08806388213559AnyOne External Implant System
08806388213535AnyOne External Implant System
08806388213511AnyOne External Implant System
08806388213498AnyOne External Implant System
08806388213467AnyOne External Implant System
08806388213450AnyOne External Implant System
08806388213429AnyOne External Implant System
08806388213412AnyOne External Implant System
08806388213382AnyOne External Implant System
08806388213375AnyOne External Implant System
08806388213344AnyOne External Implant System
08806388213337AnyOne External Implant System
08806388213306AnyOne External Implant System
08806388213290AnyOne External Implant System
08806388213269AnyOne External Implant System
08806388213252AnyOne External Implant System
08806388213238AnyOne External Implant System
08806388213214AnyOne External Implant System
08806388213191AnyOne External Implant System
08806388213177AnyOne External Implant System
08806388213153AnyOne External Implant System
08806388213139AnyOne External Implant System
08806388213115AnyOne External Implant System
08806388213092AnyOne External Implant System
08806388213078AnyOne External Implant System
08806388213054AnyOne External Implant System
08806388213030AnyOne External Implant System
08806388213016AnyOne External Implant System
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