BruxZir 70-1175-BZA0016

GUDID D745701175BZA00161

BruxZir Anterior-16 GL Single Unit D4

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701175BZA00161
• NIH Device Record Key: 15425ae8-1005-4949-8f0e-67c0e8204a72
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir
• Version Model Number: 70-1175-BZA0016
• Catalog Number: 70-1175-BZA0016
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 40
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• 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

Customer Support Contacts

• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com
• Phone: +1(949)440-2629
• Email: Shelly.Harris@glidewelldental.com

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701175BZA00160 [Unit of Use]
HIBCC	D745701175BZA00161 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K143330

FDA Product Code

• EIH: POWDER, PORCELAIN

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 5
• Public Version Date: 2023-08-22
• Device Publish Date: 2016-09-23

On-Brand Devices [BruxZir]

• D745701182BZE05581: BruxZir Esthetic GL Single Unit - White
• D745701182BZE05571: BruxZir Esthetic GL Single Unit - Bleach
• D745701182BZE05561: BruxZir Esthetic GL Single Unit - D4
• D745701182BZE05551: BruxZir Esthetic GL Single Unit - D3
• D745701182BZE05541: BruxZir Esthetic GL Single Unit - D2
• D745701182BZE05531: BruxZir Esthetic GL Single Unit - C4
• D745701182BZE05521: BruxZir Esthetic GL Single Unit - C3
• D745701182BZE05511: BruxZir Esthetic GL Single Unit - C2
• D745701182BZE05501: BruxZir Esthetic GL Single Unit - C1
• D745701182BZE05491: BruxZir Esthetic GL Single Unit - B4
• D745701182BZE05481: BruxZir Esthetic GL Single Unit - B3
• D745701182BZE05471: BruxZir Esthetic GL Single Unit - B2
• D745701182BZE05461: BruxZir Esthetic GL Single Unit - B1
• D745701182BZE05451: BruxZir Esthetic GL Single Unit - A4
• D745701182BZE05441: BruxZir Esthetic GL Single Unit - A3.5
• D745701182BZE05431: BruxZir Esthetic GL Single Unit - A3
• D745701182BZE05421: BruxZir Esthetic GL Single Unit - A2
• D745701182BZE05411: BruxZir Esthetic GL Single Unit - A1
• D745701182BZE01800: BruxZir Esthetic White 25mm Z
• D745701182BZE01790: BruxZir Esthetic White 20mm Z
• D745701182BZE01780: BruxZir Esthetic White 16mm Z
• D745701182BZE01770: BruxZir Esthetic White 14mm Z
• D745701182BZE01760: BruxZir Esthetic White 12mm Z
• D745701182BZE01750: BruxZir Esthetic Bleach 25mm Z
• D745701182BZE01740: BruxZir Esthetic Bleach 20mm Z
• D745701182BZE01730: BruxZir Esthetic Bleach 16mm Z
• D745701182BZE01720: BruxZir Esthetic Bleach 14mm Z
• D745701182BZE01710: BruxZir Esthetic Bleach 12mm Z
• D745701182BZE01700: BruxZir Esthetic D4 25mm Z
• D745701182BZE01690: BruxZir Esthetic D4 20mm Z
• D745701182BZE01680: BruxZir Esthetic D4 16mm Z
• D745701182BZE01670: BruxZir Esthetic D4 14mm Z
• D745701182BZE01660: BruxZir Esthetic D4 12mm Z
• D745701182BZE01650: BruxZir Esthetic D3 25mm Z
• D745701182BZE01640: BruxZir Esthetic D3 20mm Z
• D745701182BZE01630: BruxZir Esthetic D3 16mm Z
• D745701182BZE01620: BruxZir Esthetic D3 14mm Z
• D745701182BZE01610: BruxZir Esthetic D3 12mm Z
• D745701182BZE01600: BruxZir Esthetic D2 25mm Z
• D745701182BZE01590: BruxZir Esthetic D2 20mm Z
• D745701182BZE01580: BruxZir Esthetic D2 16mm Z
• D745701182BZE01570: BruxZir Esthetic D2 14mm Z
• D745701182BZE01560: BruxZir Esthetic D2 12mm Z
• D745701182BZE01550: BruxZir Esthetic C4 25mm Z
• D745701182BZE01540: BruxZir Esthetic C4 20mm Z
• D745701182BZE01530: BruxZir Esthetic C4 16mm Z
• D745701182BZE01520: BruxZir Esthetic C4 14mm Z
• D745701182BZE01510: BruxZir Esthetic C4 12mm Z
• D745701182BZE01500: BruxZir Esthetic C3 25mm Z
• D745701182BZE01490: BruxZir Esthetic C3 20mm Z