BruxZir™ Basic Shade Coloring Liquid 70-1123-BRX0011

GUDID D745701123BRX00110

BruxZir™ Basic Shade Coloring Liquid - B2

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701123BRX00110
• NIH Device Record Key: 9733e5e5-ffd2-45d3-9768-3c82c1174986
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir™ Basic Shade Coloring Liquid
• Version Model Number: 70-1123-BRX0011
• Catalog Number: 70-1123-BRX0011
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701123BRX00110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K220960

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: 2022-10-19
• Device Publish Date: 2022-10-11

On-Brand Devices [BruxZir™ Basic Shade Coloring Liquid]

• D745701123BRX00240: BruxZir™ Basic Shade Coloring Liquid - 0M1
• D745701123BRX00230: BruxZir™ Basic Shade Coloring Liquid - C4
• D745701123BRX00220: BruxZir™ Basic Shade Coloring Liquid - A4
• D745701123BRX00210: BruxZir™ Basic Shade Coloring Liquid - Dilute
• D745701123BRX00200: BruxZir™ Basic Shade Coloring Liquid - 0M3
• D745701123BRX00190: BruxZir™ Basic Shade Coloring Liquid - D4
• D745701123BRX00180: BruxZir™ Basic Shade Coloring Liquid - D3
• D745701123BRX00170: BruxZir™ Basic Shade Coloring Liquid - D2
• D745701123BRX00160: BruxZir™ Basic Shade Coloring Liquid - C3
• D745701123BRX00150: BruxZir™ Basic Shade Coloring Liquid - C2
• D745701123BRX00140: BruxZir™ Basic Shade Coloring Liquid - C1
• D745701123BRX00130: BruxZir™ Basic Shade Coloring Liquid - B4
• D745701123BRX00120: BruxZir™ Basic Shade Coloring Liquid - B3
• D745701123BRX00110: BruxZir™ Basic Shade Coloring Liquid - B2
• D745701123BRX00100: BruxZir™ Basic Shade Coloring Liquid - B1
• D745701123BRX00090: BruxZir™ Basic Shade Coloring Liquid - A3.5
• D745701123BRX00080: BruxZir™ Basic Shade Coloring Liquid - A3
• D745701123BRX00070: BruxZir™ Basic Shade Coloring Liquid - A2
• D745701123BRX00060: BruxZir™ Basic Shade Coloring Liquid - A1