BruxZir Shaded 16 PLUS 70-1185-BXP0085

GUDID D745701185BXP00850

BruxZir Shaded 16 PLUS Milling Blank A3.5 GD 20mm Z

Prismatik Dentalcraft, Inc

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• Primary Device ID: D745701185BXP00850
• NIH Device Record Key: 85bfa83e-8ff6-46c1-ace6-85abe85ba942
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir Shaded 16 PLUS
• Version Model Number: 70-1185-BXP0085
• Catalog Number: 70-1185-BXP0085
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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: 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(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	D745701185BXP00850 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K130924

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: 2
• Public Version Date: 2023-08-22
• Device Publish Date: 2020-06-12

On-Brand Devices [BruxZir Shaded 16 PLUS]

• D745701185BXP03040: BruxZir Shaded 16 PLUS Milling Blank White 30mm Z
• D745701185BXP03030: BruxZir Shaded 16 PLUS Milling Blank White 25mm Z
• D745701185BXP03020: BruxZir Shaded 16 PLUS Milling Blank White 20mm Z
• D745701185BXP03010: BruxZir Shaded 16 PLUS Milling Blank White 16mm Z
• D745701185BXP03000: BruxZir Shaded 16 PLUS Milling Blank White 14mm Z
• D745701185BXP02990: BruxZir Shaded 16 PLUS Milling Blank White 12mm Z
• D745701185BXP02980: BruxZir Shaded 16 PLUS Milling Blank White 10mm Z
• D745701185BXP02970: BruxZir Shaded 16 PLUS Milling Blank White GD 30mm Z
• D745701185BXP02960: BruxZir Shaded 16 PLUS Milling Blank White GD 25mm Z
• D745701185BXP02950: BruxZir Shaded 16 PLUS Milling Blank White GD 20mm Z
• D745701185BXP02940: BruxZir Shaded 16 PLUS Milling Blank White GD 16mm Z
• D745701185BXP02930: BruxZir Shaded 16 PLUS Milling Blank White GD 14mm Z
• D745701185BXP02920: BruxZir Shaded 16 PLUS Milling Blank White GD 12mm Z
• D745701185BXP02910: BruxZir Shaded 16 PLUS Milling Blank White GD 10mm Z
• D745701185BXP02900: BruxZir Shaded 16 PLUS Milling Blank BL3 30mm Z
• D745701185BXP02890: BruxZir Shaded 16 PLUS Milling Blank BL3 25mm Z
• D745701185BXP02880: BruxZir Shaded 16 PLUS Milling Blank BL3 20mm Z
• D745701185BXP02870: BruxZir Shaded 16 PLUS Milling Blank BL3 16mm Z
• D745701185BXP02860: BruxZir Shaded 16 PLUS Milling Blank BL3 14mm Z
• D745701185BXP02850: BruxZir Shaded 16 PLUS Milling Blank BL3 12mm Z
• D745701185BXP02840: BruxZir Shaded 16 PLUS Milling Blank BL3 10mm Z
• D745701185BXP02830: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 30mm Z
• D745701185BXP02820: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 25mm Z
• D745701185BXP02810: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 20mm Z
• D745701185BXP02800: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 16mm Z
• D745701185BXP02790: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 14mm Z
• D745701185BXP02780: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 12mm Z
• D745701185BXP02770: BruxZir Shaded 16 PLUS Milling Blank BL3 GD 10mm Z
• D745701185BXP02760: BruxZir Shaded 16 PLUS Milling Blank BL1 30mm Z
• D745701185BXP02750: BruxZir Shaded 16 PLUS Milling Blank BL1 25mm Z
• D745701185BXP02740: BruxZir Shaded 16 PLUS Milling Blank BL1 20mm Z
• D745701185BXP02730: BruxZir Shaded 16 PLUS Milling Blank BL1 16mm Z
• D745701185BXP02720: BruxZir Shaded 16 PLUS Milling Blank BL1 14mm Z
• D745701185BXP02710: BruxZir Shaded 16 PLUS Milling Blank BL1 12mm Z
• D745701185BXP02700: BruxZir Shaded 16 PLUS Milling Blank BL1 10mm Z
• D745701185BXP02690: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 30mm Z
• D745701185BXP02680: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 25mm Z
• D745701185BXP02670: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 20mm Z
• D745701185BXP02660: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 16mm Z
• D745701185BXP02650: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 14mm Z
• D745701185BXP02640: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 12mm Z
• D745701185BXP02630: BruxZir Shaded 16 PLUS Milling Blank BL1 GD 10mm Z
• D745701185BXP02620: BruxZir Shaded 16 PLUS Milling Blank D4 30mm Z
• D745701185BXP02610: BruxZir Shaded 16 PLUS Milling Blank D4 25mm Z
• D745701185BXP02600: BruxZir Shaded 16 PLUS Milling Blank D4 20mm Z
• D745701185BXP02590: BruxZir Shaded 16 PLUS Milling Blank D4 16mm Z
• D745701185BXP02580: BruxZir Shaded 16 PLUS Milling Blank D4 14mm Z
• D745701185BXP02570: BruxZir Shaded 16 PLUS Milling Blank D4 12mm Z
• D745701185BXP02560: BruxZir Shaded 16 PLUS Milling Blank D4 10mm Z
• D745701185BXP02550: BruxZir Shaded 16 PLUS Milling Blank D4 GD 30mm Z