i-Clean Free Abutment

GUDID 08806169166609

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

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169166609
• NIH Device Record Key: 7964b3d8-f04f-40ef-98ff-ae81229a82bf
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Free Abutment
• Version Model Number: DIFANS
• 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	08806169166609 [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

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

Moist Heat or Steam Sterilization

[08806169166609]

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 Free Abutment]

• 08806169166609: Dental Implant System / i-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169166593: Dental Implant System / i-Clean Free Abutment Set (Abutment + Abutment Screw)