i-Clean Gold Cylinder

GUDID 08806169166647

Dental Implant System / i-Clean Gold Cylinder Set (Cylinder + Cylinder Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169166647
• NIH Device Record Key: 3462b3b5-5409-49c7-b366-4445a40a26f5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Gold Cylinder
• Version Model Number: DIOGCNS
• 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	08806169166647 [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

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

[08806169166647]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-23

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)