s-Clean Free Abutment

GUDID 08806169192981

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

DENTIS CO., LTD.

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 08806169192981
• NIH Device Record Key: 8051ccd1-9e0f-49f9-ba67-58101f0711fc
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Free Abutment
• Version Model Number: DSFA65HS
• 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	08806169192981 [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

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

Moist Heat or Steam Sterilization

[08806169192981]

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: 2019-05-31

On-Brand Devices [s-Clean Free Abutment]

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• 08806169102294: Dental Implant System / s-Clean Free Abutment D5.5mm / Hex / Non-Coating
• 08806169102287: Dental Implant System / s-Clean Free Abutment D4.5mm / Non-Hex / Non-Coating
• 08806169102270: Dental Implant System / s-Clean Free Abutment D4.5mm / Hex / Non-Coating
• 08806169110022: Dental Implant System / s-Clean Free Abutment D6.5mm / Non-Hex / Non-Coating
• 08806169110015: Dental Implant System / s-Clean Free Abutment D6.5mm / Hex / Non-Coating
• 08806169193018: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169193001: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169192998: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169192981: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169192974: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)
• 08806169192967: Dental Implant System / s-Clean Free Abutment Set (Abutment + Abutment Screw)