ZANTEX AR01

GUDID D916AR011

ZANTEX METAL-FREE SUPRASTRUCTURE ARCH CONFIGURATION COMPOSITE MATERIAL

BIOFUNCTIONAL MATERIALS LLC

Dental implant suprastructure, permanent, preformed

• Primary Device ID: D916AR011
• NIH Device Record Key: 114fff23-4929-4c9c-89b5-14755a1ceeb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZANTEX
• Version Model Number: AR01
• Catalog Number: AR01
• Company DUNS: 117102295
• Company Name: BIOFUNCTIONAL MATERIALS LLC
• Device Count: 1
• DM Exempt: true
• Pre-market Exempt: true
• 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: 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D916AR011 [Primary]

FDA Product Code

• NDP: Accessories, Implant, Dental, Endosseous

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2019-11-08
• Device Publish Date: 2019-06-19

On-Brand Devices [ZANTEX]

• D916DC010: ZANTEX METAL-FREE SUPRASTRUCTURE DISK CONFIGURATION COMPOSITE MATERIAL
• D916AR011: ZANTEX METAL-FREE SUPRASTRUCTURE ARCH CONFIGURATION COMPOSITE MATERIAL
• D916DC03161: DISK CONFIGURATION DIA95X16MM, NOTCHES, COMPOSITE MATERIAL
• D916DC03141: DISK CONFIGURATION DIA95X14MM, NOTCHES, COMPOSITE MATERIAL
• D916DC02161: DISK CONFIGURATION DIA98X16MM, TRIANGULAR, COMPOSITE MATERIAL
• D916DC02141: DISK CONFIGURATION DIA98X14MM, TRIANGULAR, COMPOSITE MATERIAL
• D916DC02101: DISK CONFIGURATION DIA98X10MM, TRIANGULAR, COMPOSITE MATERIAL
• D916DC01171: DISK CONFIGURATION DIA98X17MM, COMPOSITE MATERIAL
• D916DC01161: DISK CONFIGURATION DIA98X16MM, COMPOSITE MATERIAL
• D916DC01141: DISK CONFIGURATION DIA98X14MM, COMPOSITE MATERIAL