BruxZir Esthetic NOW 70-1182-NOW0011

GUDID D745701182NOW00110

BruxZir Esthetic NOW - C2

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701182NOW00110
• NIH Device Record Key: 5e1c860e-bb71-416e-8da1-a8934469b2a0
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir Esthetic NOW
• Version Model Number: 70-1182-NOW0011
• Catalog Number: 70-1182-NOW0011
• 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: 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(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	D745701182NOW00110 [Unit of Use]
HIBCC	D745701182NOW00111 [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: 2020-04-20
• Device Publish Date: 2020-04-10

On-Brand Devices [BruxZir Esthetic NOW]

• D745701182NOW00180: BruxZir Esthetic NOW - Bleach White
• D745701182NOW00170: BruxZir Esthetic NOW - Bleach 1
• D745701182NOW00160: BruxZir Esthetic NOW - D4
• D745701182NOW00150: BruxZir Esthetic NOW - D3
• D745701182NOW00140: BruxZir Esthetic NOW - D2
• D745701182NOW00130: BruxZir Esthetic NOW - C4
• D745701182NOW00120: BruxZir Esthetic NOW - C3
• D745701182NOW00110: BruxZir Esthetic NOW - C2
• D745701182NOW00100: BruxZir Esthetic NOW - C1
• D745701182NOW00090: BruxZir Esthetic NOW - B4
• D745701182NOW00080: BruxZir Esthetic NOW - B3
• D745701182NOW00070: BruxZir Esthetic NOW - B2
• D745701182NOW00060: BruxZir Esthetic NOW - B1
• D745701182NOW00050: BruxZir Esthetic NOW - A4
• D745701182NOW00040: BruxZir Esthetic NOW - A3.5
• D745701182NOW00030: BruxZir Esthetic NOW - A3
• D745701182NOW00020: BruxZir Esthetic NOW - A2
• D745701182NOW00010: BruxZir Esthetic NOW - A1