s-Clean Gold UCLA Abutment

GUDID 08806169192226

Dental Implant System / s-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169192226
• NIH Device Record Key: 29509d75-1137-4c2e-8ff8-181d2ed4b7af
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Gold UCLA Abutment
• Version Model Number: DSGCNS
• 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	08806169192226 [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

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

[08806169192226]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-05-28

On-Brand Devices [s-Clean Gold UCLA Abutment]

• 08806169102584: Dental Implant System / s-Clean Gold UCLA Abutment D4.5mm X L12.0mm / Non-Hex
• 08806169102577: Dental Implant System / s-Clean Gold UCLA Abutment D4.5mm X L12.0mm / Hex
• 08806169109088: Dental Implant System / s-Clean Gold UCLA Abutment D4.0mm X L14.5mm / Non-Hex
• 08806169109071: Dental Implant System / s-Clean Gold UCLA Abutment D4.0mm X L15.0mm / Hex
• 08806169192226: Dental Implant System / s-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
• 08806169192219: Dental Implant System / s-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
• 08806169191557: Dental Implant System / s-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)
• 08806169191540: Dental Implant System / s-Clean Gold UCLA Abutment Set (Abutment + Abutment Screw)