e-Clean tapered Fixture

GUDID 08806169141446

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

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169141446
• NIH Device Record Key: a63a5014-6ffa-4363-8a35-b827adfc2ec5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: e-Clean tapered Fixture
• Version Model Number: DEFR4114M
• 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	08806169141446 [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: 2019-06-20
• Device Publish Date: 2019-06-12

On-Brand Devices [e-Clean tapered Fixture]

• 08806169102829: Dental Implant System / e-Clean tapered Fixture D5.1mm X L14.0mm
• 08806169102812: Dental Implant System / e-Clean tapered Fixture D5.1mm X L12.0mm
• 08806169102805: Dental Implant System / e-Clean tapered Fixture D5.1mm X L10.0mm
• 08806169102799: Dental Implant System / e-Clean tapered Fixture D5.1mm X L8.0mm
• 08806169102782: Dental Implant System / e-Clean tapered Fixture D4.1mm X L14.0mm
• 08806169102775: Dental Implant System / e-Clean tapered Fixture D4.1mm X L12.0mm
• 08806169102768: Dental Implant System / e-Clean tapered Fixture D4.1mm X L10.0mm
• 08806169102751: Dental Implant System / e-Clean tapered Fixture D4.1mm X L8.0mm
• 08806169102744: Dental Implant System / e-Clean tapered Fixture D3.5mm X L14.0mm
• 08806169102737: Dental Implant System / e-Clean tapered Fixture D3.5mm X L12.0mm
• 08806169102720: Dental Implant System / e-Clean tapered Fixture D3.5mm X L10.0mm
• 08806169102713: Dental Implant System / e-Clean tapered Fixture D3.5mm X L8.0mm
• 08806169141477: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141460: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141453: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141446: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141439: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141422: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141415: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141408: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141392: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141385: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141378: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Mount + Cover Screw + Mount Screw
• 08806169141231: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141224: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141132: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141101: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141095: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141088: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141071: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141064: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141057: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141040: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)
• 08806169141033: Dental Implant System / e-Clean tapered Fixture Set (Fixture + Cover Screw)