i-Clean Octa Abutment

GUDID 08806169100566

Dental Implant System / i-Clean Octa Abutment D3.5mm X L7.0mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169100566
• NIH Device Record Key: 8a288412-bd87-413e-87d9-dbab7e670338
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Octa Abutment
• Version Model Number: DIOA
• 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	08806169100566 [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

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

[08806169100566]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-08-21

On-Brand Devices [i-Clean Octa Abutment]

• 08806169100566: Dental Implant System / i-Clean Octa Abutment D3.5mm X L7.0mm
• 08806169165503: Dental Implant System / i-Clean Octa Abutment D4.3mm X L7.3mm
• 08806169112088: Dental Implant System / i-Clean Octa Abutment Set (Abutment + Healing Cap + Cylinder Screw)
• 08806169166203: Dental Implant System / i-Clean Octa Abutment Set (Abutment + Healing Cap + Cylinder Screw)