AnyOne Onestage Fixture OSF4513LH

GUDID 08806388247080

Ø4.5/ L=13/ C=2.2

Megagen Implant Co. Ltd

Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece Screw endosteal dental implant, two-piece
Primary Device ID08806388247080
NIH Device Record Key380afdcb-21ad-4cd2-a353-2533649f397c
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyOne Onestage Fixture
Version Model NumberOSF4513L
Catalog NumberOSF4513LH
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
GS108806388247080 [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 Date2021-07-09
Device Publish Date2021-07-01

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08806388270927Ø4.5/ L=15/ C=1.2
08806388270910Ø4.5/ L=13/ C=1.2
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08806388273010Ø4/ L=8.5/ C=2.2
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08806388247271Ø5/ L=15/ C=2.2
08806388247264Ø5/ L=13/ C=2.2
08806388247257Ø5/ L=11.5/ C=2.2
08806388247240Ø5/ L=10/ C=2.2
08806388247233Ø5/ L=8.5/ C=2.2
08806388247226Ø5/ L=7/ C=2.2
08806388247219Ø4.5/ L=15/ C=2.2
08806388247202Ø4.5/ L=13/ C=2.2
08806388247196Ø4.5/ L=11.5/ C=2.2
08806388247189Ø4.5/ L=10/ C=2.2
08806388247172Ø4.5/ L=8.5/ C=2.2
08806388247165Ø4.5/ L=7/ C=2.2
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08806388246908Ø5/ L=13/ C=1.8
08806388246892Ø5/ L=11.5/ C=1.8
08806388246885Ø5/ L=10/ C=1.8
08806388246878Ø5/ L=8.5/ C=1.8
08806388246861Ø5/ L=7/ C=1.8
08806388246854Ø4.5/ L=15/ C=1.8
08806388246847Ø4.5/ L=13/ C=1.8
08806388246809Ø4.5/ L=7/ C=1.8
08806388246762Ø5/ L=10/ C=1.8
08806388273072Ø5/ L=10/ C=2.2
08806388273065Ø5/ L=8.5/ C=2.2
08806388273058Ø5/ L=7/ C=2.2
08806388273041Ø4.5/ L=10/ C=2.2
08806388273034Ø4.5/ L=8.5/ C=2.2
08806388273027Ø4/ L=10/ C=2.2
08806388270866Ø5/ L=15/ C=1.2
08806388270859Ø5/ L=13/ C=1.2
08806388270842Ø5/ L=11.5/ C=1.2
08806388270835Ø5/ L=10/ C=1.2

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