i-Clean Healing Abutment

GUDID 08806169105004

Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height2.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169105004
• NIH Device Record Key: d797253f-8568-433f-a038-c42c611d13e5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Healing Abutment
• Version Model Number: DIH20
• 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: true
• 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	08806169105004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-06
• Device Publish Date: 2015-07-30

On-Brand Devices [i-Clean Healing Abutment]

• 08806169100283: Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height5.5mm
• 08806169100276: Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height4.0mm
• 08806169100269: Dental Implant System / i-Clean Healing Abutment D6.4mm, Post Height3.0mm
• 08806169100160: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height5.5mm
• 08806169100153: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height4.0mm
• 08806169100146: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height3.0mm
• 08806169105011: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height7.0mm
• 08806169105004: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height2.0mm
• 08806169132512: Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height5.5mm
• 08806169132505: Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height4.0mm
• 08806169132499: Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height3.0mm
• 08806169132482: Dental Implant System / i-Clean Healing Abutment D6.9mm, Post Height2.0mm
• 08806169132475: Dental Implant System / i-Clean Healing Abutment D5.5mm, Post Height4.5mm