s-Clean SAVE II Fixture

GUDID 08806169150134

Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L10.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169150134
• NIH Device Record Key: 5827aafa-4f54-4628-b926-eed3e6bf047e
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SAVE II Fixture
• Version Model Number: DS2FS5510
• 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	08806169150134 [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: 2019-06-12
• Device Publish Date: 2019-06-04

On-Brand Devices [s-Clean SAVE II Fixture]

• 08806169125408: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125392: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125385: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125378: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125361: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125354: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125347: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125330: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125323: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169125316: Dental Implant System / s-Clean SAVE II Fixture Set (Fixture + Cover Screw)
• 08806169150196: Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L12.0mm
• 08806169150189: Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L10.0mm
• 08806169150172: Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L9.0mm
• 08806169150165: Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L8.0mm
• 08806169150158: Dental Implant System / s-Clean SAVE II Fixture D6.0mm X L7.0mm
• 08806169150141: Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L12.0mm
• 08806169150134: Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L10.0mm
• 08806169150127: Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L9.0mm
• 08806169150110: Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L8.0mm
• 08806169150103: Dental Implant System / s-Clean SAVE II Fixture D5.5mm X L7.0mm