i-Clean straight Fixture

GUDID 08806169123954

Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169123954
• NIH Device Record Key: 24695e8a-994f-48d8-b131-19bf7b0b434f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean straight Fixture
• Version Model Number: DISF4116LS
• 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	08806169123954 [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: 2019-06-21
• Device Publish Date: 2019-06-13

On-Brand Devices [i-Clean straight Fixture]

• 08806169123800: Dental Implant System / i-Clean straight Fixture D4.3mm X L10.0mm
• 08806169123794: Dental Implant System / i-Clean straight Fixture D4.3mm X L8.0mm
• 08806169123763: Dental Implant System / i-Clean straight Fixture D4.1mm X L14.0mm
• 08806169123756: Dental Implant System / i-Clean straight Fixture D4.1mm X L12.0mm
• 08806169123749: Dental Implant System / i-Clean straight Fixture D4.1mm X L10.0mm
• 08806169123732: Dental Implant System / i-Clean straight Fixture D4.1mm X L8.0mm
• 08806169146908: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)
• 08806169146892: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)
• 08806169146786: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)
• 08806169146779: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)
• 08806169124074: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124067: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124050: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124043: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124036: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124012: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169124005: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123992: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123985: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123978: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123954: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123947: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123930: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123923: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123916: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123893: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123886: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123879: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123862: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123855: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123831: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123824: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123817: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169123770: Dental Implant System / i-Clean straight Fixture Set (Fixture + Closing Screw)
• 08806169146762: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)
• 08806169146755: Dental Implant System / i-Clean straight Fixture Set (Fixture + Cover Screw)