s-Clean staight Fixtutre

GUDID 08806169125644

Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169125644
• NIH Device Record Key: 9ab892f0-d75a-41ce-8834-a18a2d5b7a64
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: s-Clean staight Fixtutre
• Version Model Number: DSSF4312S
• 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	08806169125644 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171027

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-06-11
• Device Publish Date: 2019-06-03

On-Brand Devices [s-Clean staight Fixtutre]

• 08806169125729: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125712: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125705: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125699: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125682: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125668: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125651: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125644: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125637: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125620: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125606: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125590: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125583: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125576: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)
• 08806169125569: Dental Implant System / s-Clean Straight Fixture Set (Fixture + Cover Screw)