Hero 2 & IS Dental Implant System

GUDID 08809488217120

Hero 2 & IS Dental Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08809488217120
NIH Device Record Key8ab277fe-d924-4fa1-aa73-fe0d2534acfb
Commercial Distribution StatusIn Commercial Distribution
Brand NameHero 2 & IS Dental Implant System
Version Model NumberIS600115
Company DUNS688476027
Company NameKJMEDITECH.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 Numberfalse
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
GS108809488217120 [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 Date2019-11-25
Device Publish Date2019-11-15

On-Brand Devices [Hero 2 & IS Dental Implant System]

08809488217199Hero 2 & IS Dental Implant System/Cover Screw
08809488217182Hero 2 & IS Dental Implant System/Cover Screw
08809488217175Hero 2 & IS Dental Implant System/Cover Screw
08809488217168Hero 2 & IS Dental Implant System/Cover Screw
08809488217151Hero 2 & IS Dental Implant System/Mount Abutment &Screw
08809488217144Hero 2 & IS Dental Implant System/Mount Abutment &Screw
08809488217137Hero 2 & IS Dental Implant System/Fixture
08809488217120Hero 2 & IS Dental Implant System/Fixture
08809488217113Hero 2 & IS Dental Implant System/Fixture
08809488217106Hero 2 & IS Dental Implant System/Fixture
08809488217090Hero 2 & IS Dental Implant System/Fixture
08809488217083Hero 2 & IS Dental Implant System/Fixture
08809488217076Hero 2 & IS Dental Implant System/Fixture
08809488217069Hero 2 & IS Dental Implant System/Fixture
08809488217052Hero 2 & IS Dental Implant System/Fixture
08809488217045Hero 2 & IS Dental Implant System/Fixture
08809488217038Hero 2 & IS Dental Implant System/Fixture
08809488217021Hero 2 & IS Dental Implant System/Fixture
08809488217014Hero 2 & IS Dental Implant System/Fixture
08809488217007Hero 2 & IS Dental Implant System/Fixture
08809488216994Hero 2 & IS Dental Implant System/Fixture
08809488216987Hero 2 & IS Dental Implant System/Fixture
08809488216970Hero 2 & IS Dental Implant System/Fixture
08809488216963Hero 2 & IS Dental Implant System/Fixture
08809488216956Hero 2 & IS Dental Implant System/Fixture
08809488216949Hero 2 & IS Dental Implant System/Fixture
08809488216932Hero 2 & IS Dental Implant System/Fixture
08809488216925Hero 2 & IS Dental Implant System/Fixture
08809488216918Hero 2 & IS Dental Implant System/Fixture
08809488216901Hero 2 & IS Dental Implant System/Fixture
08809488216895Hero 2 & IS Dental Implant System/Fixture
08809488216888Hero 2 & IS Dental Implant System/Fixture
08809488216871Hero 2 & IS Dental Implant System/Fixture
08809488216864Hero 2 & IS Dental Implant System/Fixture
08809488216857Hero 2 & IS Dental Implant System/Fixture
08809488216840Hero 2 & IS Dental Implant System/Fixture
08809488216833Hero 2 & IS Dental Implant System/Fixture
08809488216826Hero 2 & IS Dental Implant System/Fixture
08809488216819Hero 2 & IS Dental Implant System/Fixture
08809488216802Hero 2 & IS Dental Implant System/Fixture
08809488216796Hero 2 & IS Dental Implant System/Fixture
08809488216789Hero 2 & IS Dental Implant System/Fixture
08809488216772Hero 2 & IS Dental Implant System/Fixture
08809488216765Hero 2 & IS Dental Implant System/Fixture
08809488216758Hero 2 & IS Dental Implant System/Fixture
08809488216741Hero 2 & IS Dental Implant System/Fixture
08809488216734Hero 2 & IS Dental Implant System/Fixture
08809488216727Hero 2 & IS Dental Implant System/Fixture
08809488216710Hero 2 & IS Dental Implant System/Fixture
08809488216703Hero 2 & IS Dental Implant System/Fixture

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.