i-Clean Angled Abutment

GUDID 08806169105110

Dental Implant System / i-Clean Angled Abutment D5.2mm X L9.55, Angulation20° / Octa

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169105110
• NIH Device Record Key: 5cbac8f2-dbd4-4d57-9ae0-0dd32ebf6ee9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Angled Abutment
• Version Model Number: SIAA20
• 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	08806169105110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K082843

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

Moist Heat or Steam Sterilization

[08806169105110]

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: 2015-07-30

On-Brand Devices [i-Clean Angled Abutment]

• 08806169104571: Dental Implant System / i-Clean Angled Abutment D3.7mm X L9.4mm, Angulation25° / Octa
• 08806169104564: Dental Implant System / i-Clean Angled Abutment D3.7mm X L9.4mm, Angulation15° / Octa
• 08806169105110: Dental Implant System / i-Clean Angled Abutment D5.2mm X L9.55, Angulation20° / Octa