i-Clean tapered Fixture

GUDID 08806169146748

Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169146748
• NIH Device Record Key: 2946a1ee-b3b4-4bcf-887f-e482027185c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: i-Clean tapered Fixture
• Version Model Number: DIFW4814S
• 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	08806169146748 [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: 2019-07-04
• Device Publish Date: 2019-06-26

On-Brand Devices [i-Clean tapered Fixture]

• 08806169100009: Dental Implant System / i-Clean tapered Fixture D3.7mm X L8.0mm
• 08806169100115: Dental Implant System / i-Clean tapered Fixture D4.7mm X L14.0mm
• 08806169100108: Dental Implant System / i-Clean tapered Fixture D4.7mm X L12.0mm
• 08806169100092: Dental Implant System / i-Clean tapered Fixture D4.7mm X L10.0mm
• 08806169100085: Dental Implant System / i-Clean tapered Fixture D4.7mm X L8.0mm
• 08806169100078: Dental Implant System / i-Clean tapered Fixture D4.3mm X L14.0mm
• 08806169100061: Dental Implant System / i-Clean tapered Fixture D4.3mm X L12.0mm
• 08806169100054: Dental Implant System / i-Clean tapered Fixture D4.3mm X L10.0mm
• 08806169100047: Dental Implant System / i-Clean tapered Fixture D4.3mm X L8.0mm
• 08806169100030: Dental Implant System / i-Clean tapered Fixture D3.7mm X L14.0mm
• 08806169100023: Dental Implant System / i-Clean tapered Fixture D3.7mm X L12.0mm
• 08806169100016: Dental Implant System / i-Clean tapered Fixture D3.7mm X L10.0mm
• 08806169124203: Dental Implant System / i-Clean tapered Fixture D4.7mm X L14.0mm
• 08806169124197: Dental Implant System / i-Clean tapered Fixture D4.7mm X L12.0mm
• 08806169124180: Dental Implant System / i-Clean tapered Fixture D4.7mm X L10.0mm
• 08806169124173: Dental Implant System / i-Clean tapered Fixture D4.7mm X L8.0mm
• 08806169124135: Dental Implant System / i-Clean tapered Fixture D4.1mm X L14.0mm
• 08806169124128: Dental Implant System / i-Clean tapered Fixture D4.1mm X L12.0mm
• 08806169124111: Dental Implant System / i-Clean tapered Fixture D4.1mm X L10.0mm
• 08806169124104: Dental Implant System / i-Clean tapered Fixture D4.1mm X L8.0mm
• 08806169146748: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146632: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146625: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146618: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146601: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146595: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146496: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146489: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146472: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169146465: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145819: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145802: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145796: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145772: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145765: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145758: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145741: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145734: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145659: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169145642: Dental Implant System / i-Clean tapered Fixture Set (Fixture + Cover Screw)