i-Clean Temporary Abutment

GUDID 08806169108760

Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / PEEK / Non-Octa

DENTIS CO., LTD.

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• Primary Device ID: 08806169108760
• NIH Device Record Key: fadbe8c5-806c-4929-bf35-738ccacfc1c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean Temporary Abutment
• Version Model Number: DIPT20N
• 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	08806169108760 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K111364

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

Moist Heat or Steam Sterilization

[08806169108760]

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: 2015-08-25

On-Brand Devices [ i-Clean Temporary Abutment ]

• 08806169100658: Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / Titanium / Octa
• 08806169100641: Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff1.0mm / Titanium / Non-Octa
• 08806169100634: Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff1.0mm / Titanium / Octa
• 08806169108760: Dental Implant System / i-Clean Temporary Abutment D5.2mm, Cuff2.0mm / PEEK / Non-Octa