s-Clean CCM UCLA Abutment

GUDID 08806169190598

Dental Implant System / s-Clean CCM UCLA Abutment D4.5mm X L15.39mm / Non-Hex

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169190598
• NIH Device Record Key: 66d57f8e-5cf1-4fed-b13c-517c95a88fcc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean CCM UCLA Abutment
• Version Model Number: DSCUAN
• 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	08806169190598 [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

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

Moist Heat or Steam Sterilization

[08806169190598]

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: 2019-05-27

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

• 08806169107817: Dental Implant System / s-Clean CCM UCLA Abutment D4.0mm X L14.5mm / Non-Hex
• 08806169107800: Dental Implant System / s-Clean CCM UCLA Abutment D4.0mm X L15.0mm / Hex
• 08806169190598: Dental Implant System / s-Clean CCM UCLA Abutment D4.5mm X L15.39mm / Non-Hex
• 08806169190581: Dental Implant System / s-Clean CCM UCLA Abutment D4.5mm X L15.44mm / Hex
• 08806169191717: Dental Implant System / s-Clean CCM UCLA Abutment (Abutment + Abutment Screw)
• 08806169191700: Dental Implant System / s-Clean CCM UCLA Abutment (Abutment + Abutment Screw)