i-Clean tapered Fixture

GUDID 08806169124197

Dental Implant System / i-Clean tapered Fixture D4.7mm X L12.0mm

DENTIS CO., LTD.

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• Primary Device ID: 08806169124197
• NIH Device Record Key: c26919d3-2014-4f66-9acd-6e557b55a84f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean tapered Fixture
• Version Model Number: DIFW4812
• 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	08806169124197 [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: 3
• Public Version Date: 2019-05-08
• Device Publish Date: 2018-02-02

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