I-FIX Free Abutment

GUDID 08806169104359

Dental Implant System / I-FIX Free Abutment D4.0mm X L12.0mm / Hex

DENTIS CO., LTD.

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• Primary Device ID: 08806169104359
• NIH Device Record Key: 1f95c13d-52e7-46ce-804f-404b11b38514
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: I-FIX Free Abutment
• Version Model Number: DMFAH
• 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: false
• 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	08806169104359 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K083586

FDA Product Code

• NHA: Abutment, Implant, Dental, Endosseous

Sterilization

• Steralize Prior To Use: true
• Device Is Sterile: false

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

[08806169104359]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 6
• Public Version Date: 2019-11-08
• Device Publish Date: 2015-09-01

On-Brand Devices [I-FIX Free Abutment]

• 08806169104366: Dental Implant System / I-FIX Free Abutment D4.0mm X L12.0mm / Non-Hex
• 08806169104359: Dental Implant System / I-FIX Free Abutment D4.0mm X L12.0mm / Hex