s-Clean O-Ring Abutment

GUDID 08806169102683

Dental Implant System / s-Clean O-Ring Abutment D3.4mm Cuff0.3mm

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169102683
• NIH Device Record Key: 78f02670-16fe-44cf-8450-c1f0c5a9995b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean O-Ring Abutment
• Version Model Number: DSORA00
• 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	08806169102683 [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

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

Moist Heat or Steam Sterilization

[08806169102683]

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: 2015-08-31

On-Brand Devices [s-Clean O-Ring Abutment]

• 08806169102706: Dental Implant System / s-Clean O-Ring Abutment D4.5mm Cuff3.8mm
• 08806169102690: Dental Implant System / s-Clean O-Ring Abutment D4.5mm Cuff1.8mm
• 08806169102683: Dental Implant System / s-Clean O-Ring Abutment D3.4mm Cuff0.3mm
• 08806169131805: Dental Implant System / s-Clean O-Ring Abutment D3.5mm X L12.0mm
• 08806169131799: Dental Implant System / s-Clean O-Ring Abutment D3.5mm X L10.0mm