s-Clean OneQ-SL Fixture

GUDID 08806169127549

Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L10.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece
Primary Device ID08806169127549
NIH Device Record Key32c3047b-f33b-4c41-9ecc-93d1e5223f56
Commercial Distribution StatusIn Commercial Distribution
Brand Names-Clean OneQ-SL Fixture
Version Model NumberDSSOFR4210
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
GS108806169127549 [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 Number4
Public Version Date2019-05-07
Device Publish Date2016-05-18

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

08806169146571Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L14.0mm
08806169146564Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L12.0mm
08806169146557Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L10.0mm
08806169146540Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L8.0mm
08806169146533Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L7.0mm
08806169127884Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L14.0mm
08806169127877Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L12.0mm
08806169127860Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L10.0mm
08806169127853Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L8.0mm
08806169127846Dental Implant System / s-Clean OneQ-SL Regular Type D3.9mm X L7.0mm
08806169127839Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L14.0mm
08806169127822Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L12.0mm
08806169127815Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L10.0mm
08806169127808Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L8.0mm
08806169127792Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L7.0mm
08806169127785Dental Implant System / s-Clean OneQ-SL Wide Type D8.0mm X L12.0mm
08806169127761Dental Implant System / s-Clean OneQ-SL Wide Type D8.0mm X L8.0mm
08806169127754Dental Implant System / s-Clean OneQ-SL Wide Type D8.0mm X L7.0mm
08806169127747Dental Implant System / s-Clean OneQ-SL Wide Type D7.0mm X L12.0mm
08806169127730Dental Implant System / s-Clean OneQ-SL Wide Type D7.0mm X L10.0mm
08806169127723Dental Implant System / s-Clean OneQ-SL Wide Type D7.0mm X L8.0mm
08806169127716Dental Implant System / s-Clean OneQ-SL Wide Type D7.0mm X L7.0mm
08806169127709Dental Implant System / s-Clean OneQ-SL Wide Type D6.0mm X L12.0mm
08806169127693Dental Implant System / s-Clean OneQ-SL Wide Type D6.0mm X L10.0mm
08806169127686Dental Implant System / s-Clean OneQ-SL Wide Type D6.0mm X L8.0mm
08806169127679Dental Implant System / s-Clean OneQ-SL Wide Type D6.0mm X L7.0mm
08806169127662Dental Implant System / s-Clean OneQ-SL Regular Type D5.2mm X L14.0mm
08806169127655Dental Implant System / s-Clean OneQ-SL Regular Type D5.2mm X L12.0mm
08806169127648Dental Implant System / s-Clean OneQ-SL Regular Type D5.2mm X L10.0mm
08806169127631Dental Implant System / s-Clean OneQ-SL Regular Type D5.2mm X L8.0mm
08806169127624Dental Implant System / s-Clean OneQ-SL Regular Type D5.2mm X L7.0mm
08806169127617Dental Implant System / s-Clean OneQ-SL Regular Type D4.7mm X L14.0mm
08806169127600Dental Implant System / s-Clean OneQ-SL Regular Type D4.7mm X L12.0mm
08806169127594Dental Implant System / s-Clean OneQ-SL Regular Type D4.7mm X L10.0mm
08806169127587Dental Implant System / s-Clean OneQ-SL Regular Type D4.7mm X L8.0mm
08806169127570Dental Implant System / s-Clean OneQ-SL Regular Type D4.7mm X L7.0mm
08806169127563Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L14.0mm
08806169127556Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L12.0mm
08806169127549Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L10.0mm
08806169127532Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L8.0mm
08806169127525Dental Implant System / s-Clean OneQ-SL Regular Type D4.2mm X L7.0mm
08806169127518Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L14.0mm
08806169127501Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L12.0mm
08806169127495Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L10.0mm
08806169127488Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L8.0mm
08806169127471Dental Implant System / s-Clean OneQ-SL Regular Type D3.7mm X L7.0mm
08806169127426Dental Implant System / s-Clean OneQ-SL Narrow Type D3.3mm X L14.0mm
08806169127419Dental Implant System / s-Clean OneQ-SL Narrow Type D3.3mm X L12.0mm
08806169127402Dental Implant System / s-Clean OneQ-SL Narrow Type D3.3mm X L10.0mm
08806169127389Dental Implant System / s-Clean OneQ-SL Narrow Type D3.0mm X L14.0mm

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