s-Clean Free-Healing Abutment

GUDID 08806169101358

Dental Implant System / s-Clean Free-Healing Abutment D4.5mm X L11.3mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169101358
• NIH Device Record Key: 6f4cba5a-3dbf-4390-82f6-b6dcce4c09e2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean Free-Healing Abutment
• Version Model Number: DSFH4545
• 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: true
• 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	08806169101358 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2019-05-02
• Device Publish Date: 2015-08-24

On-Brand Devices [s-Clean Free-Healing Abutment]

• 08806169101372: Dental Implant System / s-Clean Free-Healing Abutment D5.5mm X L11.3mm
• 08806169101365: Dental Implant System / s-Clean Free-Healing Abutment D5.5mm X L9.3mm
• 08806169101358: Dental Implant System / s-Clean Free-Healing Abutment D4.5mm X L11.3mm
• 08806169101341: Dental Implant System / s-Clean Free-Healing Abutment D4.5mm X L9.3mm
• 08806169133960: Dental Implant System / s-Clean Free-Healing Abutment D6.5mm X L10.8mm
• 08806169133953: Dental Implant System / s-Clean Free-Healing Abutment D6.5mm X L8.8mm
• 08806169133946: Dental Implant System / s-Clean Free-Healing Abutment D5.5mm X L10.8mm
• 08806169133939: Dental Implant System / s-Clean Free-Healing Abutment D5.5mm X L8.8mm
• 08806169133922: Dental Implant System / s-Clean Free-Healing Abutment D4.5mm X L10.8mm
• 08806169133915: Dental Implant System / s-Clean Free-Healing Abutment D4.5mm X L8.8mm
• 08806169133908: Dental Implant System / s-Clean Free-Healing Abutment D6.5mm X L11.3mm
• 08806169133892: Dental Implant System / s-Clean Free-Healing Abutment D6.5mm X L9.3mm