s-Clean SAVE Fixture

GUDID 08806169105783

Dental Implant System / s-Clean SAVE Fixture D7.0mm X L12.4mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169105783
• NIH Device Record Key: c750d380-58f5-49e2-899c-1e499ec3bfde
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean SAVE Fixture
• Version Model Number: DSFS7012
• 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	08806169105783 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082843

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: 2019-05-06
• Device Publish Date: 2015-08-20

On-Brand Devices [s-Clean SAVE Fixture]

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• 08806169101402: Dental Implant System / s-Clean SAVE Fixture D5.5mm X L10.4mm
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• 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
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• 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)