i-Clean Gold Cylinder

GUDID 08806169100627

Dental Implant System / i-Clean Gold Cylinder D5.0mm / Non-Octa

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: 08806169100627
• NIH Device Record Key: e3b6e555-d0bc-41e5-b398-62f22a6134ec
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Gold Cylinder
• Version Model Number: DIOGCN
• 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	08806169100627 [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

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

Moist Heat or Steam Sterilization

[08806169100627]

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 Gold Cylinder]

• 08806169100627: Dental Implant System / i-Clean Gold Cylinder D5.0mm / Non-Octa
• 08806169100610: Dental Implant System / i-Clean Gold Cylinder D5.0mm / Octa
• 08806169166104: Dental Implant System / i-Clean Gold Cylinder D6.8mm / Non-Octa
• 08806169166098: Dental Implant System / i-Clean Gold Cylinder D6.8mm / Octa
• 08806169109040: Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
• 08806169109033: Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
• 08806169166647: Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)
• 08806169166630: Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)