i-Clean Temporary Abutment

GUDID 08806169165862

Dental Implant System / i-Clean Temporary Abutment D6.8mm X L11.5mm / Titanium / Octa

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169165862
• NIH Device Record Key: 80655bd8-1e1b-4d6f-bb15-4dd9cb5c4df7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Temporary Abutment
• Version Model Number: DIOTWO
• 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: false
• 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	08806169165862 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

[08806169165862]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

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• 08806169165893: Dental Implant System / i-Clean Temporary Abutment D6.9mm, Cuff2.0mm / Titanium / Octa
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• 08806169165879: Dental Implant System / i-Clean Temporary Abutment D6.8mm X L11.5mm / Non-Octa
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