s-Clean straight Fixture

GUDID 08806169149954

Dental Implant System / s-Clean straight Fixture D4.3mm X L8.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169149954
• NIH Device Record Key: d6f2815f-8392-4dd6-952a-074080268b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean straight Fixture
• Version Model Number: DSSF4308
• 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	08806169149954 [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 straight Fixture]

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• 08806169150035: Dental Implant System / s-Clean straight Fixture D4.75mm X L12.0mm
• 08806169150028: Dental Implant System / s-Clean straight Fixture D4.75mm X L10.0mm
• 08806169150011: Dental Implant System / s-Clean straight Fixture D4.75mm X L8.0mm
• 08806169149992: Dental Implant System / s-Clean straight Fixture D4.3mm X L16.0mm
• 08806169149985: Dental Implant System / s-Clean straight Fixture D4.3mm X L14.0mm
• 08806169149978: Dental Implant System / s-Clean straight Fixture D4.3mm X L12.0mm
• 08806169149961: Dental Implant System / s-Clean straight Fixture D4.3mm X L10.0mm
• 08806169149954: Dental Implant System / s-Clean straight Fixture D4.3mm X L8.0mm
• 08806169149930: Dental Implant System / s-Clean straight Fixture D4.1mm X L16.0mm
• 08806169149923: Dental Implant System / s-Clean straight Fixture D4.1mm X L14.0mm
• 08806169149633: Dental Implant System / s-Clean straight Fixture D4.1mm X L12.0mm
• 08806169149626: Dental Implant System / s-Clean straight Fixture D4.1mm X L10.0mm
• 08806169149619: Dental Implant System / s-Clean straight Fixture D4.1mm X L8.0mm