i-Clean OneQ-SL Fixture

GUDID 08806169127969

Dental Implant System / i-Clean OneQ-SL Fixture Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169127969
NIH Device Record Keyef9bac31-f1a3-4318-80a3-0eeb379218a6
Commercial Distribution StatusIn Commercial Distribution
Brand Namei-Clean OneQ-SL Fixture
Version Model NumberDISOF4847073S
Company DUNS688204158
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 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
GS108806169127969 [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 Date2019-05-20
Device Publish Date2019-05-10

On-Brand Devices [i-Clean OneQ-SL Fixture]

08806169126559Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L12.0mm
08806169126030Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L8.0mm
08806169126641Dental Implant System / i-Clean OneQ-SL Fixture D5.8mm X L12.0mm
08806169126634Dental Implant System / i-Clean OneQ-SL Fixture D5.8mm X L10.0mm
08806169126627Dental Implant System / i-Clean OneQ-SL Fixture D5.8mm X L8.0mm
08806169126610Dental Implant System / i-Clean OneQ-SL Fixture D5.8mm X L7.0mm
08806169126603Dental Implant System / i-Clean OneQ-SL Fixture D4.8mm X L12.0mm
08806169126597Dental Implant System / i-Clean OneQ-SL Fixture D4.8mm X L10.0mm
08806169126580Dental Implant System / i-Clean OneQ-SL Fixture D4.8mm X L8.0mm
08806169126573Dental Implant System / i-Clean OneQ-SL Fixture D4.8mm X L7.0mm
08806169126566Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L14.0mm
08806169126542Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L10.0mm
08806169126535Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L8.0mm
08806169126511Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L14.0mm
08806169126504Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L12.0mm
08806169126498Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L10.0mm
08806169126481Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L8.0mm
08806169126474Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L7.0mm
08806169126467Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L14.0mm
08806169126450Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L12.0mm
08806169126443Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L10.0mm
08806169126436Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L8.0mm
08806169126429Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L7.0mm
08806169126412Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L14.0mm
08806169126405Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L12.0mm
08806169126399Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L10.0mm
08806169126382Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L8.0mm
08806169126375Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L7.0mm
08806169126368Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L14.0mm
08806169126351Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L12.0mm
08806169126344Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L10.0mm
08806169126320Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L7.0mm
08806169126313Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L14.0mm
08806169126306Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L12.0mm
08806169126290Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L10.0mm
08806169126283Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L8.0mm
08806169126276Dental Implant System / i-Clean OneQ-SL Fixture D4.2mm X L7.0mm
08806169126269Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L14.0mm
08806169126252Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L12.0mm
08806169126245Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L10.0mm
08806169126238Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L8.0mm
08806169126221Dental Implant System / i-Clean OneQ-SL Fixture D3.7mm X L7.0mm
08806169126214Dental Implant System / i-Clean OneQ-SL Fixture D3.55mm X L14.0mm
08806169126207Dental Implant System / i-Clean OneQ-SL Fixture D3.55mm X L12.0mm
08806169126191Dental Implant System / i-Clean OneQ-SL Fixture D3.55mm X L10.0mm
08806169126184Dental Implant System / i-Clean OneQ-SL Fixture D3.55mm X L8.0mm
08806169126177Dental Implant System / i-Clean OneQ-SL Fixture D3.55mm X L7.0mm
08806169126160Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L14.0mm
08806169126153Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L12.0mm
08806169126146Dental Implant System / i-Clean OneQ-SL Fixture D4.7mm X L10.0mm
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