BruxZir™ TintEFX Coloring Liquid 70-1123-BRX0028

GUDID D745701123BRX00280

BruxZir™ TintEFX Coloring Liquid - G3

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701123BRX00280
• NIH Device Record Key: 043bddbf-feb5-4c31-8ce1-44aa4e93deb4
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir™ TintEFX Coloring Liquid
• Version Model Number: 70-1123-BRX0028
• Catalog Number: 70-1123-BRX0028
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx
• Phone: +1(800)854-7256
• Email: xx@xx.xx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701123BRX00280 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231347

FDA Product Code

• EIH: POWDER, PORCELAIN

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: 2023-07-03
• Device Publish Date: 2023-06-23

On-Brand Devices [BruxZir™ TintEFX Coloring Liquid]

• D745701123BRX00410: BruxZir™ TintEFX Coloring Liquid - Yellow
• D745701123BRX00400: BruxZir™ TintEFX Coloring Liquid - Grey
• D745701123BRX00390: BruxZir™ TintEFX Coloring Liquid - Purple
• D745701123BRX00380: BruxZir™ TintEFX Coloring Liquid - Orange
• D745701123BRX00370: BruxZir™ TintEFX Coloring Liquid - Pink
• D745701123BRX00360: BruxZir™ TintEFX Coloring Liquid - Blue
• D745701123BRX00350: BruxZir™ TintEFX Coloring Liquid - Green
• D745701123BRX00340: BruxZir™ TintEFX Coloring Liquid - Brown
• D745701123BRX00300: BruxZir™ TintEFX Coloring Liquid - G5
• D745701123BRX00290: BruxZir™ TintEFX Coloring Liquid - G4
• D745701123BRX00280: BruxZir™ TintEFX Coloring Liquid - G3
• D745701123BRX00270: BruxZir™ TintEFX Coloring Liquid - G1
• D745701123BRX00260: BruxZir™ TintEFX Coloring Liquid - G0
• D745701123BRX00250: BruxZir™ TintEFX Coloring Liquid - G00