Vitacrilic® 9163-00

GUDID B7159163000

Soft Conditioner

FRICKE INTERNATIONAL, INC.

Dental appliance fabrication material, cured

• Primary Device ID: B7159163000
• NIH Device Record Key: 215c290c-66ae-4cc0-b44d-04bc9afe5737
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitacrilic®
• Version Model Number: 9163-00
• Catalog Number: 9163-00
• Company DUNS: 957630726
• Company Name: FRICKE INTERNATIONAL, INC.
• Device Count: 1
• DM Exempt: false
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 630-540-1900
• Email: customerservice@frickedental.c
• Phone: 630-540-1900
• Email: customerservice@frickedental.c
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com
• Phone: 630-540-1900
• Email: customerservice@frickedental.com

Device Dimensions

• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter
• Total Volume: 940 Milliliter

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B7159163000 [Primary]

FDA Product Code

• EBI: Resin, Denture, Relining, Repairing, Rebasing

Sterilization

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

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-03-28
• Device Publish Date: 2019-03-20

On-Brand Devices [Vitacrilic®]

• B71501040006P0: Special Fibered #49
• B71501040001P0: Special Fibered #49
• B7159163000: Soft Conditioner
• B7159162000: Soft Conditioner
• B7159161000: Soft Conditioner
• B7159143000: MSI Monomer
• B7159142000: MSI Monomer
• B7159141000: MSI Monomer
• B7159113000: Medium Soft Monomer
• B7159112000: Medium Soft Monomer
• B7159111000: Medium Soft Monomer
• B7159095000: Rapid Cure Monomer
• B7159094000: 9094-00
• B7159093020: Rapid Cure Monomer
• B7159093000: Rapid Cure Monomer
• B7159088000: Vitacrilic® Universal Blue Tint Monomer 940 mL
• B7159087000: Vitacrilic® Universal Blue Tint Monomer 470 mL
• B7159069000: Vitacrilic® Clear Self Curing Monomer
• B7159066000: Vitacrilic® Clear Self Curing Monomer
• B7159065000: Vitacrilic® Clear Self Curing Monomer
• B7159064000: Vitacrilic® Clear Self Curing Monomer
• B7159034000: Cross Link Colorstable Self Curing Monomer
• B7159033000: Cross Link Colorstable Self Curing Monomer
• B7159032000: Cross Link Colorstable Self Curing Monomer
• B7159031000: Cross Link Colorstable Self Curing Monomer
• B7159023000: Pour Monomer
• B7159021010: Pour Monomer
• B7159021000: Pour Monomer
• B7159013000: Cross Link Monomer
• B7159012000: Cross Link Monomer
• B7159011000: Cross Link Monomer
• B7159003000: Tray Monomer 235 mL
• B7159002000: Tray Monomer 470 mL
• B7159001000: Tray Monomer 940mL
• B715250160320: HI-JECT MONOMER #2
• B715240240480: Universal Clear
• B71524024006P0: Universal Clear
• B71524024001P0: Universal Clear
• B71524013006P0: Vitacrilic® Clear Self Curing
• B71524013001P0: Vitacrilic® Clear Self Curing
• B715240060700: Clear Soft Type I
• B715240060200: Clear Soft Type I
• B715240060060: Clear Soft Type I
• B715240030200: Clear Soft
• B715240030060: Clear Soft
• B715240030010: Clear Soft
• B71503023025P0: Special Grain #3 Short Fibered LW
• B71503023006P0: Special Grain #3 Short Fibered LW
• B71503015006P0: SPECIAL FIBERED #4 LW
• B71501053025P0: Fibered XL2