i-Clean straight Fixture

GUDID 08806169143129

Dental Implant System / i-Clean straight Fixture D4.25mm X L12.0mm

DENTIS CO. ,LTD

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169143129
• NIH Device Record Key: 7c8d1a80-5237-49b9-bdbb-9ff65e2914d4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean straight Fixture
• Version Model Number: DISF4312S
• Company DUNS: 694721181
• 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: true
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: true
• Contains Natural Rubber Latex: true
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	08806169143129 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2020-07-27
• Device Publish Date: 2019-06-18

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• 08806169143174: Dental Implant System / i-Clean straight Fixture D4.75mm X L10.0mm
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• 08806169143136: Dental Implant System / i-Clean straight Fixture D4.25mm X L14.0mm
• 08806169143129: Dental Implant System / i-Clean straight Fixture D4.25mm X L12.0mm