Zfx™

GUDID 00889024344464

BIOMET 3I, LLC

Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed Dental implant suprastructure, permanent, preformed 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

• 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
• 00844868044321 - Driva™ Gold Series Drills: 2023-11-07 Dríva ™ Gold Series Drills Tapered Pilot Drill, Single Patient, 2.1/1.6mm(D) X 8mm - 11.5mm(L)
• 00844868044338 - Driva™ Gold Series Drills: 2023-11-07 Dríva ™ Gold Series Drills Round Bur, 2.0mm