BruxZir Shaded 16 PLUS 70-1186-BXP0057

GUDID D745701186BXP00570

BruxZir Shaded 16 PLUS Milling Blank A2 GD 20mm Z

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701186BXP00570
• NIH Device Record Key: d4cd1503-01d6-4a44-ae6b-9c8dfb92e14c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir Shaded 16 PLUS
• Version Model Number: 70-1186-BXP0057
• Catalog Number: 70-1186-BXP0057
• 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
• 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	D745701186BXP00570 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2021-09-02
• Device Publish Date: 2021-08-25

On-Brand Devices [BruxZir Shaded 16 PLUS]

• D745701186BXP00660: BruxZir Shaded 16 PLUS Milling Blank A2 30mm Z
• D745701186BXP00650: BruxZir Shaded 16 PLUS Milling Blank A2 25mm Z
• D745701186BXP00640: BruxZir Shaded 16 PLUS Milling Blank A2 20mm Z
• D745701186BXP00630: BruxZir Shaded 16 PLUS Milling Blank A2 16mm Z
• D745701186BXP00620: BruxZir Shaded 16 PLUS Milling Blank A2 14mm Z
• D745701186BXP00610: BruxZir Shaded 16 PLUS Milling Blank A2 12mm Z
• D745701186BXP00600: BruxZir Shaded 16 PLUS Milling Blank A2 10mm Z
• D745701186BXP00590: BruxZir Shaded 16 PLUS Milling Blank A2 GD 30mm Z
• D745701186BXP00580: BruxZir Shaded 16 PLUS Milling Blank A2 GD 25mm Z
• D745701186BXP00570: BruxZir Shaded 16 PLUS Milling Blank A2 GD 20mm Z
• D745701186BXP00560: BruxZir Shaded 16 PLUS Milling Blank A2 GD 16mm Z
• D745701186BXP00550: BruxZir Shaded 16 PLUS Milling Blank A2 GD 14mm Z
• D745701186BXP00540: BruxZir Shaded 16 PLUS Milling Blank A2 GD 12mm Z
• D745701186BXP00530: BruxZir Shaded 16 PLUS Milling Blank A2 GD 10mm Z
• D745701186BXP00250: BruxZir Shaded 16 PLUS GL Bridge Block - B1
• D745701186BXP00210: BruxZir Shaded 16 PLUS GL Bridge Block - A2
• D745701186BXP00060: BruxZir Shaded 16 PLUS GL Single Unit Block - B1
• D745701186BXP00020: BruxZir Shaded 16 PLUS GL Single Unit Block - A2
• D745701186BXP01220: BruxZir Shaded 16 PLUS Milling Blank B1 30mm Z
• D745701186BXP01210: BruxZir Shaded 16 PLUS Milling Blank B1 25mm Z
• D745701186BXP01200: BruxZir Shaded 16 PLUS Milling Blank B1 20mm Z
• D745701186BXP01190: BruxZir Shaded 16 PLUS Milling Blank B1 16mm Z
• D745701186BXP01180: BruxZir Shaded 16 PLUS Milling Blank B1 14mm Z
• D745701186BXP01170: BruxZir Shaded 16 PLUS Milling Blank B1 12mm Z
• D745701186BXP01160: BruxZir Shaded 16 PLUS Milling Blank B1 10mm Z
• D745701186BXP01150: BruxZir Shaded 16 PLUS Milling Blank B1 GD 30mm Z
• D745701186BXP01140: BruxZir Shaded 16 PLUS Milling Blank B1 GD 25mm Z
• D745701186BXP01130: BruxZir Shaded 16 PLUS Milling Blank B1 GD 20mm Z
• D745701186BXP01120: BruxZir Shaded 16 PLUS Milling Blank B1 GD 16mm Z
• D745701186BXP01110: BruxZir Shaded 16 PLUS Milling Blank B1 GD 14mm Z
• D745701186BXP01100: BruxZir Shaded 16 PLUS Milling Blank B1 GD 12mm Z
• D745701186BXP01090: BruxZir Shaded 16 PLUS Milling Blank B1 GD 10mm Z