s-Clean CCM UCLA Abutment

GUDID 08806169107800

Dental Implant System / s-Clean CCM UCLA Abutment D4.0mm X L15.0mm / Hex

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169107800
• NIH Device Record Key: fe4fb1f4-6dd7-470a-8ab1-1e33919be8b8
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean CCM UCLA Abutment
• Version Model Number: DSCUASH
• 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	08806169107800 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161244

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

Moist Heat or Steam Sterilization

[08806169107800]

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: 2017-01-10

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)