s-Clean OneQ-SL Narrow Fixture

GUDID 08806169127365

Dental Implant System / s-Clean OneQ-SL Narrow Type D3.0mm X L10.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169127365
• NIH Device Record Key: 1542ccf8-9905-4986-b4b5-102ac2e57c5b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean OneQ-SL Narrow Fixture
• Version Model Number: DSSOFS3010
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169127365 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161244

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-07
• Device Publish Date: 2017-01-10

Devices Manufactured by DENTIS CO., LTD.

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• 08800053022385 - s-Clean SQ-SL Fixture: 2021-03-08 Dental Implant System / s-Clean SQ-SL Fixture (DSSFR5507)
• 08806169155979 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1 X L7.0 mm
• 08806169155986 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L7.5mm
• 08806169155993 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L9.5mm
• 08806169156006 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L11.5mm
• 08806169156013 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.1mm X L13.5mm
• 08806169156020 - s-Clean SQ-SL Fixture: 2020-05-01 s-Clean SQ-SL Fixture / D4.4mm X L7.0mm