BruxZir Esthetic 70-1183-BEP0053

GUDID D745701183BEP00530

BruxZir Esthetic Milling Blank A2 20mm Z

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701183BEP00530
• NIH Device Record Key: cbecae98-54a9-4705-a046-8dd0dc554c99
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir Esthetic
• Version Model Number: 70-1183-BEP0053
• Catalog Number: 70-1183-BEP0053
• 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: 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
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• Phone: +1(800)854-7256
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• 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
• 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	D745701183BEP00530 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K213425

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: 2021-12-30
• Device Publish Date: 2021-12-22

On-Brand Devices [BruxZir Esthetic]

• D745701183BEP01900: BruxZir Esthetic Milling Blank White 25mm Z
• D745701183BEP01890: BruxZir Esthetic Milling Blank White 20mm Z
• D745701183BEP01880: BruxZir Esthetic Milling Blank White 16mm Z
• D745701183BEP01870: BruxZir Esthetic Milling Blank White 14mm Z
• D745701183BEP01860: BruxZir Esthetic Milling Blank White GD 25mm Z
• D745701183BEP01850: BruxZir Esthetic Milling Blank White GD 20mm Z
• D745701183BEP01840: BruxZir Esthetic Milling Blank White GD 16mm Z
• D745701183BEP01830: BruxZir Esthetic Milling Blank White GD 14mm Z
• D745701183BEP01820: BruxZir Esthetic Milling Blank BL3 25mm Z
• D745701183BEP01810: BruxZir Esthetic Milling Blank BL3 20mm Z
• D745701183BEP01800: BruxZir Esthetic Milling Blank BL3 16mm Z
• D745701183BEP01790: BruxZir Esthetic Milling Blank BL3 14mm Z
• D745701183BEP01780: BruxZir Esthetic Milling Blank BL3 GD 25mm Z
• D745701183BEP01770: BruxZir Esthetic Milling Blank BL3 GD 20mm Z
• D745701183BEP01760: BruxZir Esthetic Milling Blank BL3 GD 16mm Z
• D745701183BEP01750: BruxZir Esthetic Milling Blank BL3 GD 14mm Z
• D745701183BEP01740: BruxZir Esthetic Milling Blank BL1 25mm Z
• D745701183BEP01730: BruxZir Esthetic Milling Blank BL1 20mm Z
• D745701183BEP01720: BruxZir Esthetic Milling Blank BL1 16mm Z
• D745701183BEP01710: BruxZir Esthetic Milling Blank BL1 14mm Z
• D745701183BEP01700: BruxZir Esthetic Milling Blank BL1 GD 25mm Z
• D745701183BEP01690: BruxZir Esthetic Milling Blank BL1 GD 20mm Z
• D745701183BEP01680: BruxZir Esthetic Milling Blank BL1 GD 16mm Z
• D745701183BEP01670: BruxZir Esthetic Milling Blank BL1 GD 14mm Z
• D745701183BEP01660: BruxZir Esthetic Milling Blank D4 25mm Z
• D745701183BEP01650: BruxZir Esthetic Milling Blank D4 20mm Z
• D745701183BEP01640: BruxZir Esthetic Milling Blank D4 16mm Z
• D745701183BEP01630: BruxZir Esthetic Milling Blank D4 14mm Z
• D745701183BEP01620: BruxZir Esthetic Milling Blank D4 GD 25mm Z
• D745701183BEP01610: BruxZir Esthetic Milling Blank D4 GD 20mm Z
• D745701183BEP01600: BruxZir Esthetic Milling Blank D4 GD 16mm Z
• D745701183BEP01590: BruxZir Esthetic Milling Blank D4 GD 14mm Z
• D745701183BEP01580: BruxZir Esthetic Milling Blank D3 25mm Z
• D745701183BEP01570: BruxZir Esthetic Milling Blank D3 20mm Z
• D745701183BEP01560: BruxZir Esthetic Milling Blank D3 16mm Z
• D745701183BEP01550: BruxZir Esthetic Milling Blank D3 14mm Z
• D745701183BEP01540: BruxZir Esthetic Milling Blank D3 GD 25mm Z
• D745701183BEP01530: BruxZir Esthetic Milling Blank D3 GD 20mm Z
• D745701183BEP01520: BruxZir Esthetic Milling Blank D3 GD 16mm Z
• D745701183BEP01510: BruxZir Esthetic Milling Blank D3 GD 14mm Z
• D745701183BEP01500: BruxZir Esthetic Milling Blank D2 25mm Z
• D745701183BEP01490: BruxZir Esthetic Milling Blank D2 20mm Z
• D745701183BEP01480: BruxZir Esthetic Milling Blank D2 16mm Z
• D745701183BEP01470: BruxZir Esthetic Milling Blank D2 14mm Z
• D745701183BEP01460: BruxZir Esthetic Milling Blank D2 GD 25mm Z
• D745701183BEP01450: BruxZir Esthetic Milling Blank D2 GD 20mm Z
• D745701183BEP01440: BruxZir Esthetic Milling Blank D2 GD 16mm Z
• D745701183BEP01430: BruxZir Esthetic Milling Blank D2 GD 14mm Z
• D745701183BEP01420: BruxZir Esthetic Milling Blank C4 25mm Z
• D745701183BEP01410: BruxZir Esthetic Milling Blank C4 20mm Z