BruxZir NOW 70-1167-NOW0085

GUDID D745701167NOW00850

BruxZir NOW - Bleach 3

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701167NOW00850
• NIH Device Record Key: 4d749f93-8e42-447f-afc7-0a73f8364d1c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir NOW
• Version Model Number: 70-1167-NOW0085
• Catalog Number: 70-1167-NOW0085
• Company DUNS: 021228671
• Company Name: James R. Glidewell, Dental Ceramics, Inc.
• Device Count: 3
• 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
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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
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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
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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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701167NOW00850 [Unit of Use]
HIBCC	D745701167NOW00851 [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: 2020-12-07
• Device Publish Date: 2020-11-27

On-Brand Devices [BruxZir NOW]

• D74570116NOW00661: BruxZir NOW Milling Blocks Bleach White for GL Electric Mills (3-pack)
• D745701167NOW00860: BruxZir NOW - Bleach White
• D745701167NOW00850: BruxZir NOW - Bleach 3
• D745701167NOW00840: BruxZir NOW - Bleach 1
• D745701167NOW00830: BruxZir NOW - D4
• D745701167NOW00820: BruxZir NOW - D3
• D745701167NOW00810: BruxZir NOW - D2
• D745701167NOW00800: BruxZir NOW - C4
• D745701167NOW00790: BruxZir NOW - C3
• D745701167NOW00780: BruxZir NOW - C2
• D745701167NOW00770: BruxZir NOW - C1
• D745701167NOW00760: BruxZir NOW - B4
• D745701167NOW00750: BruxZir NOW - B3
• D745701167NOW00740: BruxZir NOW - B2
• D745701167NOW00730: BruxZir NOW - B1
• D745701167NOW00720: BruxZir NOW - A4
• D745701167NOW00710: BruxZir NOW - A3.5
• D745701167NOW00700: BruxZir NOW - A3
• D745701167NOW00690: BruxZir NOW - A2
• D745701167NOW00680: BruxZir NOW - A1
• D745701182NOW00240: BruxZir NOW Bridge Block - D2
• D745701182NOW00230: BruxZir NOW Bridge Block - C2
• D745701182NOW00220: BruxZir NOW Bridge Block - B1
• D745701182NOW00210: BruxZir NOW Bridge Block - A3
• D745701182NOW00200: BruxZir NOW Bridge Block - A2
• D745701182NOW00190: BruxZir NOW Bridge Block - A1