s-Clean Sub-Octa Abutment

GUDID 08806169102553

Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff4.3mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169102553
• NIH Device Record Key: 7eca9f57-839b-452a-af35-96a10cd0e9d7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Sub-Octa Abutment
• Version Model Number: DSOA484
• 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	08806169102553 [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

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

Moist Heat or Steam Sterilization

[08806169102553]

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: 2015-08-30

On-Brand Devices [s-Clean Sub-Octa Abutment]

• 08806169102560: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff5.3mm
• 08806169102553: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff4.3mm
• 08806169102546: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff3.3mm
• 08806169102539: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff2.3mm
• 08806169102522: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff1.3mm
• 08806169102515: Dental Implant System / s-Clean Sub-Octa Abutment D4.8mm, Cuff0.8mm
• 08806169185662: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)
• 08806169185655: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)
• 08806169185648: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)
• 08806169185631: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)
• 08806169185624: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)
• 08806169185617: Dental Implant System / s-Clean Sub-Octa Abutment Set (Abutment + Healing Cap + Screw)