i-Clean straight Fixture

GUDID 08806169143129

Dental Implant System / i-Clean straight Fixture D4.25mm X L12.0mm

DENTIS 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 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 Screw endosteal dental implant, two-piece
Primary Device ID08806169143129
NIH Device Record Key7c8d1a80-5237-49b9-bdbb-9ff65e2914d4
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean straight Fixture
Version Model NumberDISF4312S
Company DUNS694721181
Company NameDENTIS 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 Datefalse
Expiration Datetrue
Donation Id Numbertrue
Contains Natural Rubber Latextrue
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS108806169143129 [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 StatusUpdate
Device Record StatusPublished
Public Version Number2
Public Version Date2020-07-27
Device Publish Date2019-06-18

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08806169143372Dental Implant System / i-Clean straight Fixture D4.75mm X L12.0mm
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08806169143327Dental Implant System / i-Clean straight Fixture D4.25mm X L14.0mm
08806169143310Dental Implant System / i-Clean straight Fixture D4.25mm X L12.0mm
08806169143303Dental Implant System / i-Clean straight Fixture D4.25mm X L10.0mm
08806169143280Dental Implant System / i-Clean straight Fixture D4.25mm X L8.0mm
08806169143259Dental Implant System / i-Clean straight Fixture D4.05mm X L14.0mm
08806169143242Dental Implant System / i-Clean straight Fixture D4.05mm X L12.0mm
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08806169143198Dental Implant System / i-Clean straight Fixture D4.75mm X L14.0mm
08806169143181Dental Implant System / i-Clean straight Fixture D4.75mm X L12.0mm
08806169143174Dental Implant System / i-Clean straight Fixture D4.75mm X L10.0mm
08806169143167Dental Implant System / i-Clean straight Fixture D4.75mm X L8.0mm
08806169143136Dental Implant System / i-Clean straight Fixture D4.25mm X L14.0mm
08806169143129Dental Implant System / i-Clean straight Fixture D4.25mm X L12.0mm
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