TSX Implants

GUDID 00844868045243

TSX™ IMPLANT, 5.4MMD, 16MML

BIOMET 3I, LLC

Screw endosteal dental implant, two-piece

• Primary Device ID: 00844868045243
• NIH Device Record Key: a0101bc4-7ea4-44b7-a01a-3fd51875e5a5
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TSX Implants
• Version Model Number: TSX54B16
• 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: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com
• Phone: +1(800)342-5454
• Email: DentalCS@zimvie.com

Device Dimensions

• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter
• Device Size Text, specify: 0
• Balloon Length: 16 Millimeter

Device Identifiers

Device Issuing Agency	Device ID
GS1	00844868045243 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220978

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: 2022-10-04
• Device Publish Date: 2022-09-26

On-Brand Devices [TSX Implants]

• 00844868045328: TSX™ IMPLANT, 6.0MMD, 8MML
• 00844868045304: TSX™ IMPLANT, 6.0MMD, 16MML
• 00844868045298: TSX™ IMPLANT, 6.0MMD, 13MML
• 00844868045281: TSX™ IMPLANT, 6.0MMD, 11.5MML
• 00844868045274: TSX™ IMPLANT, 6.0MMD, 10MML
• 00844868045267: TSX™ IMPLANT, 5.4MMD, 8MML
• 00844868045243: TSX™ IMPLANT, 5.4MMD, 16MML
• 00844868045236: TSX™ IMPLANT, 5.4MMD, 13MML
• 00844868045229: TSX™ IMPLANT, 5.4MMD, 11.5MML
• 00844868045212: TSX™ IMPLANT, 5.4MMD, 10MML
• 00844868045205: TSX™ IMPLANT, 4.7MMD, 8MML
• 00844868045182: TSX™ IMPLANT, 4.7MMD, 16MML
• 00844868045175: TSX™ IMPLANT, 4.7MMD, 13MML
• 00844868045168: TSX™ IMPLANT, 4.7MMD, 11.5MML
• 00844868045151: TSX™ IMPLANT, 4.7MMD, 10MML
• 00844868045144: TSX™ IMPLANT, 4.1MMD, 8MML
• 00844868045120: TSX™ IMPLANT, 4.1MMD, 16MML
• 00844868045113: TSX™ IMPLANT, 4.1MMD, 13MML
• 00844868045106: TSX™ IMPLANT, 4.1MMD, 11.5MML
• 00844868045090: TSX™ IMPLANT, 4.1MMD, 10MML
• 00844868045083: TSX™ IMPLANT, 3.7MMD, 8MML
• 00844868045076: TSX™ IMPLANT, 3.7MMD, 16MML
• 00844868045069: TSX™ IMPLANT, 3.7MMD, 13MML
• 00844868045052: TSX™ IMPLANT, 3.7MMD, 11.5MML
• 00844868045045: TSX™ IMPLANT, 3.7MMD, 10MML
• 00844868045038: TSX™ IMPLANT, 3.1MMD, 8MML
• 00844868045021: TSX™ IMPLANT, 3.1MMD, 16MML
• 00844868045014: TSX™ IMPLANT, 3.1MMD, 13MML
• 00844868045007: TSX™ IMPLANT, 3.1MMD, 11.5MML
• 00844868044994: TSX™ IMPLANT, 3.1MMD, 10MML