i-Clean OneQ-SL Fixture

GUDID 08806169127891

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

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 Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169127891
• NIH Device Record Key: 445d934a-547c-427b-a18e-334736623aeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean OneQ-SL Fixture
• Version Model Number: DISOF4842103S
• Company DUNS: 688204158
• Company Name: DENTIS CO., LTD.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169127891 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142313

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

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

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