s-Clean SAVE Fixture

GUDID 08806169125248

Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169125248
• NIH Device Record Key: 954548f4-8131-4606-99f3-95e744bf5c6e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SAVE Fixture
• Version Model Number: DSFS6009S
• 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	08806169125248 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

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: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [s-Clean SAVE Fixture]

• 08806169101457: Dental Implant System / s-Clean SAVE Fixture D6.0mm X L12.4mm
• 08806169101440: Dental Implant System / s-Clean SAVE Fixture D6.0mm X L10.4mm
• 08806169101433: Dental Implant System / s-Clean SAVE Fixture D6.0mm X L8.4mm
• 08806169101426: Dental Implant System / s-Clean SAVE Fixture D6.0mm X L7.4mm
• 08806169101419: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L12.4mm
• 08806169101402: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L10.4mm
• 08806169101396: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L8.4mm
• 08806169101389: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L7.4mm
• 08806169105783: Dental Implant System / s-Clean SAVE Fixture D7.0mm X L12.4mm
• 08806169105776: Dental Implant System / s-Clean SAVE Fixture D7.0mm X L10.4mm
• 08806169105769: Dental Implant System / s-Clean SAVE Fixture D7.0mm X L8.4mm
• 08806169105752: Dental Implant System / s-Clean SAVE Fixture D7.0mm X L7.4mm
• 08806169105745: Dental Implant System / s-Clean SAVE Fixture D6.5mm X L12.4mm
• 08806169105738: Dental Implant System / s-Clean SAVE Fixture D6.5mm X L10.4mm
• 08806169105721: Dental Implant System / s-Clean SAVE Fixture D6.5mm X L8.4mm
• 08806169105714: Dental Implant System / s-Clean SAVE Fixture D6.5mm X L7.4mm
• 08806169125248: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169125231: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169150073: Dental Implant System / s-Clean SAVE Fixture D6.0mm X L9.0mm
• 08806169150066: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L9.0mm
• 08806169151698: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151681: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151674: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151667: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151650: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151643: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151636: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)
• 08806169151629: Dental Implant System / s-Clean SAVE Fixture Set (Fixture + Cover Screw)