I-FIX Angled Type Fixture

GUDID 08806169104434

Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L16.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, two-piece

• Primary Device ID: 08806169104434
• NIH Device Record Key: f76cc5e7-85fa-428f-9f15-e323bac8e653
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX Angled Type Fixture
• Version Model Number: DMAF2016L
• 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	08806169104434 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083586

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

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: 2019-05-03
• Device Publish Date: 2015-07-31

On-Brand Devices [I-FIX Angled Type Fixture]

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• 08806169104526: Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L16.0mm
• 08806169104519: Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L13.0mm
• 08806169104502: Dental Implant System / I-FIX Angled Type Fixture D3.0mm X L10.0mm
• 08806169104496: Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L16.0mm
• 08806169104489: Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L13.0mm
• 08806169104472: Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L10.0mm
• 08806169104465: Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L16.0mm
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• 08806169104441: Dental Implant System / I-FIX Angled Type Fixture D2.5mm X L10.0mm
• 08806169104434: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L16.0mm
• 08806169104427: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L13.0mm
• 08806169104410: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L10.0mm
• 08806169104403: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L16.0mm
• 08806169104397: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L13.0mm
• 08806169104380: Dental Implant System / I-FIX Angled Type Fixture D2.0mm X L10.0mm