i-Clean InOcta Abutment

GUDID 08806169109101

Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169109101
• NIH Device Record Key: 9cbc6739-7b7f-4e45-84a2-f9d3788689d3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean InOcta Abutment
• Version Model Number: DICOW20S
• 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	08806169109101 [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

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

Moist Heat or Steam Sterilization

[08806169109101]

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: 2019-05-22

On-Brand Devices [i-Clean InOcta Abutment]

• 08806169100535: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff4.0mm / Non-Octa
• 08806169100528: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff4.0mm / Octa
• 08806169100511: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff3.0mm / Non-Octa
• 08806169100504: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff3.0mm / Octa
• 08806169100498: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff2.0mm / Non-Octa
• 08806169100481: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff2.0mm / Octa
• 08806169100474: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff1.0mm / Non-Octa
• 08806169100467: Dental Implant System / i-Clean InOcta Abutment D6.4mm, Cuff1.0mm / Octa
• 08806169100429: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff4.0mm / Non-Octa
• 08806169100412: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff4.0mm / Octa
• 08806169100405: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff3.0mm / Non-Octa
• 08806169100399: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff3.0mm / Octa
• 08806169100382: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff2.0mm / Non-Octa
• 08806169100375: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff2.0mm / Octa
• 08806169100368: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff1.0mm / Non-Octa
• 08806169100351: Dental Implant System / i-Clean InOcta Abutment D5.2mm, Cuff1.0mm / Octa
• 08806169166388: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166371: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166364: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166357: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166340: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166333: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166326: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166319: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166302: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166296: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166289: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166272: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166265: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166258: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166241: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166234: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169165794: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff4.0mm / Non-Octa
• 08806169165787: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff3.0mm / Non-Octa
• 08806169165770: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff2.0mm / Non-Octa
• 08806169165763: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff1.0mm / Non-Octa
• 08806169165671: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff4.0mm / Octa
• 08806169165664: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff3.0mm / Octa
• 08806169165657: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff2.0mm / Octa
• 08806169165640: Dental Implant System / i-Clean InOcta Abutment D6.9mm, Cuff1.0mm / Octa
• 08806169109163: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109156: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109149: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109132: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109125: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109118: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109101: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)
• 08806169109095: Dental Implant System / i-Clean InOcta Abutment Set (Abutment + Abutment Screw)