BruxZir NOW 70-1184-NOW0003

GUDID D745701184NOW00031

BruxZir NOW Anterior - A3

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701184NOW00031
• NIH Device Record Key: 64934655-a53c-4b5a-9b03-3ee661509bee
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir NOW
• Version Model Number: 70-1184-NOW0003
• Catalog Number: 70-1184-NOW0003
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, 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: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx
• Phone: +1(800)854-7256
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701184NOW00030 [Unit of Use]
HIBCC	D745701184NOW00031 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-08-22
• Device Publish Date: 2019-07-18

On-Brand Devices [BruxZir NOW]

• D745701184NOW00101: BruxZir NOW Anterior - D3
• D745701184NOW00091: BruxZir NOW Anterior - D2
• D745701184NOW00081: BruxZir NOW Anterior - C2
• D745701184NOW00071: BruxZir NOW Anterior - C1
• D745701184NOW00061: BruxZir NOW Anterior - B2
• D745701184NOW00051: BruxZir NOW Anterior - B1
• D745701184NOW00041: BruxZir NOW Anterior - A3.5
• D745701184NOW00031: BruxZir NOW Anterior - A3
• D745701184NOW00021: BruxZir NOW Anterior - A2
• D745701184NOW00011: BruxZir NOW Anterior - A1
• D745701167NOW01050: BruxZir NOW - Bleach White
• D745701167NOW01040: BruxZir NOW - Bleach 3
• D745701167NOW01030: BruxZir NOW - Bleach 1
• D745701167NOW01020: BruxZir NOW - D4
• D745701167NOW01010: BruxZir NOW - D3
• D745701167NOW01000: BruxZir NOW - D2
• D745701167NOW00990: BruxZir NOW - C4
• D745701167NOW00980: BruxZir NOW - C3
• D745701167NOW00970: BruxZir NOW - C2
• D745701167NOW00960: BruxZir NOW - C1
• D745701167NOW00950: BruxZir NOW - B4
• D745701167NOW00940: BruxZir NOW - B3
• D745701167NOW00930: BruxZir NOW - B2
• D745701167NOW00920: BruxZir NOW - B1
• D745701167NOW00910: BruxZir NOW - A4
• D745701167NOW00900: BruxZir NOW - A3.5
• D745701167NOW00890: BruxZir NOW - A3
• D745701167NOW00880: BruxZir NOW - A2
• D745701167NOW00870: BruxZir NOW - A1