T3

GUDID 00844868046752

T3 PRO Tapered Implant 4/3mm (D) X 8.5mm (L)

BIOMET 3I, LLC

Screw endosteal dental implant, two-piece

• Primary Device ID: 00844868046752
• NIH Device Record Key: db39a089-52ce-4995-8ee9-f9933eb086e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: T3
• Version Model Number: T3PT4385
• 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: true
• 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

Device Dimensions

• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0
• Length: 8.5 Millimeter
• Device Size Text, specify: 0

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844868046752 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213672

FDA Product Code

• DZE: Implant, Endosseous, Root-Form

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-06-13
• Device Publish Date: 2022-06-03

On-Brand Devices [T3]

• 00844868047056: T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 8.5mm (L)
• 00844868047049: T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 15mm (L)
• 00844868047032: T3 PRO Non-Platform Switched Implant 6mm (D) X 13mm (L)
• 00844868047025: T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 11.5mm (L)
• 00844868047018: T3 PRO Non-Platform Switched Tapered Implant 6mm (D) X 10mm (L)
• 00844868047001: T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 8.5mm (L)
• 00844868046998: T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 15mm (L)
• 00844868046981: T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 13mm (L)
• 00844868046974: T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 11.5mm (L)
• 00844868046967: T3 PRO Non-Platform Switched Tapered Implant 5mm (D) X 10mm (L)
• 00844868046950: T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 8.5mm (L)
• 00844868046943: T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 15mm (L)
• 00844868046936: T3 PRO Non-Platform Switched Implant 4mm (D) X 13mm (L)
• 00844868046929: T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 11.5mm (L)
• 00844868046912: T3 PRO Non-Platform Switched Tapered Implant 4mm (D) X 10mm (L)
• 00844868046851: T3 PRO Tapered Implant 6/5mm (D) X 8.5mm (L)
• 00844868046844: T3 PRO Tapered Implant 6/5mm (D) X 15mm (L)
• 00844868046837: T3 PRO Tapered Implant 6/5mm (D) X 13mm (L)
• 00844868046820: T3 PRO Tapered Implant 6/5mm (D) X 11.5mm (L)
• 00844868046813: T3 PRO Tapered Implant 6/5mm (D) X 10mm (L)
• 00844868046806: T3 PRO Tapered Implant 5/4mm (D) X 8.5mm (L)
• 00844868046790: T3 PRO Tapered Implant 5/4mm (D) X 15mm (L)
• 00844868046783: T3 PRO Tapered Implant 5/4mm (D) X 13mm (L)
• 00844868046776: T3 PRO Tapered Implant 5/4mm (D) X 11.5mm (L)
• 00844868046769: T3 PRO Tapered Implant 5/4mm (D) X 10mm (L)
• 00844868046752: T3 PRO Tapered Implant 4/3mm (D) X 8.5mm (L)
• 00844868046745: T3 PRO Tapered Implant 4/3mm (D) X 15mm (L)
• 00844868046738: T3 PRO Tapered Implant 4/3mm (D) X 13mm (L)
• 00844868046721: T3 PRO Tapered Implant 4/3mm (D) X 11.5mm (L)
• 00844868046714: T3 PRO Tapered Implant 4/3mm (D) X 10mm (L)
• 00844868046905: T3 PRO Non-Platform Switched Tapered Implant 3.25mm (D) X 8.5mm (L)
• 00844868046899: T3 PRO Non-Platform Switched Tapered Implant 3.25mm (D) X 15mm (L)
• 00844868046882: T3 PRO Non-Platform Switched Tapered Implant 3.25mm (D) X 13mm (L)
• 00844868046875: T3 PRO Non-Platform Switched Tapered Implant 3.25mm(D) X 11.5mm(L)
• 00844868046868: T3 PRO Non-Platform Switched Tapered Implant 3.25mm (D) X 10mm (L)