s-Clean OneQ-SL Fixture

GUDID 08806169110732

Dental Implant System / s-Clean OneQ-SL Wide Type 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: 08806169110732
• NIH Device Record Key: 309685de-df86-4590-9358-a069109e81a6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean OneQ-SL Fixture
• Version Model Number: DSSOFW8012S
• 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	08806169110732 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K153639

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 [s-Clean OneQ-SL Fixture]

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