BruxZir NOW 70-1182-NOW0020

GUDID D745701182NOW00200

BruxZir NOW Bridge Block - A2

James R. Glidewell, Dental Ceramics, Inc.

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701182NOW00200
• NIH Device Record Key: befe5548-511c-4537-bf60-e1e1364cadf2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir NOW
• Version Model Number: 70-1182-NOW0020
• Catalog Number: 70-1182-NOW0020
• 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: 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
• 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	D745701182NOW00200 [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: 2021-12-22
• Device Publish Date: 2021-12-10

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