i-Clean SynOcta Abutment

GUDID 08806169113511

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

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169113511
• NIH Device Record Key: a8aa24ed-0ef9-42f9-abaa-feb5c3007761
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean SynOcta Abutment
• Version Model Number: DISOWA487OS
• 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	08806169113511 [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

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

Moist Heat or Steam Sterilization

[08806169113511]

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 SynOcta Abutment]

• 08806169100450: Dental Implant System / i-Clean SynOcta Abutment D3.5mm, Post Height6.0mm / Non-Octa
• 08806169100443: Dental Implant System / i-Clean SynOcta Abutment D3.5mm, Post Height6.0mm / Octa
• 08806169113542: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169113535: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169113528: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169113511: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169113504: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169113498: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169112910: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169112903: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166227: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)
• 08806169166210: Dental Implant System / i-Clean SynOcta Abutment Set (Abutment + Abutment Screw)