Zfx™

GUDID 00889024344464

BIOMET 3I, LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: 00889024344464
• NIH Device Record Key: 04313f02-48d3-44ca-a8df-786bbd442b45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Zfx™
• Version Model Number: ZFX01000288
• Company DUNS: 186127825
• Company Name: BIOMET 3I, LLC
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: MR Conditional
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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

Customer Support Contacts

• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com
• Phone: +1(800)342-5454
• Email: 3iPBG-CS@biomet.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	00889024344464 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K142572

FDA Product Code

• NHA: ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS

Sterilization

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

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

[00889024344464]

Moist Heat or Steam Sterilization

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2019-11-08
• Device Publish Date: 2016-03-03

Devices Manufactured by BIOMET 3I, LLC

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• 00844868047827 - BellatTEK Abutment: 2024-08-16 BellatTEK Abutment EZ/TSX 2.9MM
• 00844868047063 - Ratchet Hex Driver with GemLock Retention 2.5mm (D) X 17mm (L): 2024-02-23
• 00844868047070 - Latch-Lock Hex Driver with GemLock Retention 2.5mm (D) X 21mm (L): 2024-02-23
• 00844868047087 - Ratchet Hex Driver with GemLock Retention 2.5mm (D) X 28mm (L): 2024-02-23
• 00844868047094 - Latch-Lock Hex Driver Tip with GemLock Retention 1.2mm (D) X 24mm (L): 2024-02-23
• 00844868047100 - Latch-Lock Hex Driver Tip with GemLock Retention 1.2mm (D) X 30mm (L): 2024-02-23
• 00844868047117 - Latch-Lock Hex Driver with GemLock Retention 2.5mm (D) X 30mm (L): 2024-02-23