Hero 1 Dental Implant System

GUDID 08809488217298

Hero 1 Dental Implant System/Fixture

KJMEDITECH.CO.,LTD

Screw endosteal dental implant, two-piece
Primary Device ID08809488217298
NIH Device Record Key82a656a1-6ff2-45a3-8f95-139bad90dedd
Commercial Distribution StatusIn Commercial Distribution
Brand NameHero 1 Dental Implant System
Version Model NumberMZF410160
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
GS108809488217298 [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 1 Dental Implant System]

08809488217458Hero 1 Dental Implant System/Cover Screw
08809488217441Hero 1 Dental Implant System/Cover Screw
08809488217434Hero 1 Dental Implant System/Cover Screw
08809488217427Hero 1 Dental Implant System/Mount Abutment &Screw
08809488217410Hero 1 Dental Implant System/Mount Abutment &Screw
08809488217403Hero 1 Dental Implant System/Mount Abutment &Screw
08809488217397Hero 1 Dental Implant System/Fixture
08809488217380Hero 1 Dental Implant System/Fixture
08809488217373Hero 1 Dental Implant System/Fixture
08809488217366Hero 1 Dental Implant System/Fixture
08809488217359Hero 1 Dental Implant System/Fixture
08809488217342Hero 1 Dental Implant System/Fixture
08809488217335Hero 1 Dental Implant System/Fixture
08809488217328Hero 1 Dental Implant System/Fixture
08809488217311Hero 1 Dental Implant System/Fixture
08809488217304Hero 1 Dental Implant System/Fixture
08809488217298Hero 1 Dental Implant System/Fixture
08809488217281Hero 1 Dental Implant System/Fixture
08809488217274Hero 1 Dental Implant System/Fixture
08809488217267Hero 1 Dental Implant System/Fixture
08809488217250Hero 1 Dental Implant System/Fixture
08809488217243Hero 1 Dental Implant System/Fixture
08809488217236Hero 1 Dental Implant System/Fixture
08809488217229Hero 1 Dental Implant System/Fixture
08809488217212Hero 1 Dental Implant System/Fixture
08809488217205Hero 1 Dental Implant System/Fixture

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