i-Clean Octa Abutment Healing Cap

GUDID 08806169112071

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

DENTIS CO., LTD.

Dental implant suprastructure, temporary, preformed, single-use

• Primary Device ID: 08806169112071
• NIH Device Record Key: e3470f38-6a3c-4b16-a64d-8ab8a55222b0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Octa Abutment Healing Cap
• Version Model Number: DIOWHCS
• 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	08806169112071 [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

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

[08806169112071]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-30
• Device Publish Date: 2019-05-22

On-Brand Devices [i-Clean Octa Abutment Healing Cap]

• 08806169166067: Dental Implant System / i-Clean Octa Healing Cap D6.6mm X L4.3mm
• 08806169131751: Dental Implant System / i-Clean Octa Healing Cap D6.6mm X L4.0mm
• 08806169112071: Dental Implant System / i-Clean Healing Cap Set (Healing Cap + Cylinder Screw)