AnyOne Onestage Fixture OSF5015H

GUDID 08806388246793

Ø5/ L=15/ C=1.8

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 ID08806388246793
NIH Device Record Key5ea5409e-b6d5-4228-bc9c-96f918ed9a2b
Commercial Distribution StatusIn Commercial Distribution
Brand NameAnyOne Onestage Fixture
Version Model NumberOSF5015
Catalog NumberOSF5015H
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
GS108806388246793 [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

On-Brand Devices [AnyOne Onestage Fixture]

08806388270989Ø5/ L=15/ C=1.2
08806388270972Ø5/ L=13/ C=1.2
08806388270965Ø5/ L=11.5/ C=1.2
08806388270958Ø5/ L=10/ C=1.2
08806388270941Ø5/ L=8.5/ C=1.2
08806388270934Ø5/ L=7/ C=1.2
08806388270927Ø4.5/ L=15/ C=1.2
08806388270910Ø4.5/ L=13/ C=1.2
08806388270903Ø4.5/ L=11.5/ C=1.2
08806388270897Ø4.5/ L=10/ C=1.2
08806388270880Ø4.5/ L=8.5/ C=1.2
08806388270873Ø4.5/ L=7/ C=1.2
08806388246830Ø4.5/ L=11.5/ C=1.8
08806388246823Ø4.5/ L=10/ C=1.8
08806388246816Ø4.5/ L=8.5/ C=1.8
08806388273492Ø4.5/ L=7/ C=2.2
08806388273010Ø4/ L=8.5/ C=2.2
08806388273003Ø4/ L=7/ C=2.2
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
08806388246915Ø5/ L=15/ C=1.8
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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