i-Clean Solid Abutment DISA55s

GUDID 08806169100306

Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height5.5mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169100306
• NIH Device Record Key: e04d011d-6a4c-4e3e-ba95-5b4c3d73f9ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Solid Abutment
• Version Model Number: DISA55
• Catalog Number: DISA55s
• 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	08806169100306 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• DZE: Implant, Endosseous, Root-Form
• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

[08806169100306]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 7
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-08-21

On-Brand Devices [i-Clean Solid Abutment]

• 00880616910030: Ø3.5, H:5.5mm
• 08806169100306: Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height5.5mm
• 08806169100313: Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height7.0mm
• 08806169100290: Dental Implant System / i-Clean Solid Abutment D3.5mm, Post Height4.0mm
• 08806169105042: Dental Implant System / i-Clean Solid Abutment D3.5mm X L8.0mm
• 08806169112897: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169112880: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169112873: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169166159: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169166142: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169166135: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)
• 08806169166128: Dental Implant System / i-Clean Solid Abutment Set (Abutment + Healing Cap)