i-Clean O-Ring Abutment

GUDID 08806169100795

Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L13.1mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169100795
• NIH Device Record Key: 15304f28-6e04-4907-9168-e71ca5adbb71
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean O-Ring Abutment
• Version Model Number: DIORA40
• 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	08806169100795 [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

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

Moist Heat or Steam Sterilization

[08806169100795]

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 O-Ring Abutment]

• 08806169100795: Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L13.1mm
• 08806169100788: Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L11.1mm
• 08806169100771: Dental Implant System / i-Clean O-Ring Abutment D3.5mm X L9.1mm
• 08806169131782: Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L13.4mm
• 08806169131775: Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L11.4mm
• 08806169131768: Dental Implant System / i-Clean O-Ring Abutmnent D4.3mm X L9.4mm