I-FIX O-Ring Type Fixture

GUDID 08806169104281

Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L10.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, one-piece

• Primary Device ID: 08806169104281
• NIH Device Record Key: b52cb752-bcf7-4f29-82e0-ec3958620191
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX O-Ring Type Fixture
• Version Model Number: DMOF3010L
• 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	08806169104281 [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: 5
• Public Version Date: 2019-05-08
• Device Publish Date: 2015-07-31

On-Brand Devices [I-FIX O-Ring Type Fixture]

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• 08806169104298: Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L13.0mm
• 08806169104281: Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L10.0mm
• 08806169104274: Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L16.0mm
• 08806169104267: Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L13.0mm
• 08806169104250: Dental Implant System / I-FIX O-Ring Type Fixture D3.0mm X L10.0mm
• 08806169104243: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L16.0mm
• 08806169104236: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L13.0mm
• 08806169104229: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L10.0mm
• 08806169104212: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L16.0mm
• 08806169104205: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L13.0mm
• 08806169104199: Dental Implant System / I-FIX O-Ring Type Fixture D2.5mm X L10.0mm
• 08806169104182: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L16.0mm
• 08806169104175: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L13.0mm
• 08806169104168: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L10.0mm
• 08806169104151: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L16.0mm
• 08806169104144: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L13.0mm
• 08806169104137: Dental Implant System / I-FIX O-Ring Type Fixture D2.0mm X L10.0mm