i-Clean Excellent Solid Abutment

GUDID 08806169100337

Dental Implant System / i-Clean Excellent Solid Abutment D4.3mm, Post Height5.65mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169100337
• NIH Device Record Key: 40e39df1-876d-4954-be6d-661ffb4df86d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Excellent Solid Abutment
• Version Model Number: DIESA55
• 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	08806169100337 [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

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

Moist Heat or Steam Sterilization

[08806169100337]

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: 2015-08-21

On-Brand Devices [i-Clean Excellent Solid Abutment]

• 08806169100344: Dental Implant System / i-Clean Excellent Solid Abutment D4.3mm, Post Height7.15mm
• 08806169100337: Dental Implant System / i-Clean Excellent Solid Abutment D4.3mm, Post Height5.65mm
• 08806169100320: Dental Implant System / i-Clean Excellent Solid Abutment D4.3mm, Post Height4.15mm
• 08806169105059: Dental Implant System / i-Clean Excellent Solid Abutment D4.3mm X L7.88mm
• 08806169166197: Dental Implant System / i-Clean Excellent Solid Abutment Set (Abutment + Healing Cap)
• 08806169166180: Dental Implant System / i-Clean Excellent Solid Abutment Set (Abutment + Healing Cap)
• 08806169166173: Dental Implant System / i-Clean Excellent Solid Abutment Set (Abutment + Healing Cap)
• 08806169166166: Dental Implant System / i-Clean Excellent Solid Abutment Set (Abutment + Healing Cap)