I-FIX Post Type Fixture

GUDID 08806169104021

Dental Implant System / I-FIX Post Type Fixture D2.5mm X L13.0mm

DENTIS CO., LTD.

Screw endosteal dental implant, one-piece

• Primary Device ID: 08806169104021
• NIH Device Record Key: d3503d0f-dbd9-4827-b46e-022290b5700f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX Post Type Fixture
• Version Model Number: DMPF2513S
• 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	08806169104021 [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 Post Type Fixture]

• 08806169104120: Dental Implant System / I-FIX Post Type Fixture D3.0mm X L16.0mm
• 08806169104106: Dental Implant System / I-FIX Post Type Fixture D3.0mm X L10.0mm
• 08806169104090: Dental Implant System / I-FIX Post Type Fixture D3.0mm X L16.0mm
• 08806169104083: Dental Implant System / I-FIX Post Type Fixture D3.0mm X L13.0mm
• 08806169104076: Dental Implant System / I-FIX Post Type Fixture D3.0mm X L10.0mm
• 08806169104069: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L16.0mm
• 08806169104052: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L13.0mm
• 08806169104045: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L10.0mm
• 08806169104038: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L16.0mm
• 08806169104021: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L13.0mm
• 08806169104014: Dental Implant System / I-FIX Post Type Fixture D2.5mm X L10.0mm
• 08806169104007: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L16.0mm
• 08806169103994: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L13.0mm
• 08806169103987: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L10.0mm
• 08806169103970: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L16.0mm
• 08806169103963: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L13.0mm
• 08806169103956: Dental Implant System / I-FIX Post Type Fixture D2.0mm X L10.0mm
• 08806169104113: Ø3.0x13mm