BruxZir® 70-1182-BZE0555

GUDID D745701182BZE05552

BruxZir Esthetic GL Single Unit Block - D3

Prismatik Dentalcraft, Inc

Dental appliance fabrication material, ceramic

• Primary Device ID: D745701182BZE05552
• NIH Device Record Key: bdc0298a-5b16-44f1-9749-5c958c2a938b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: BruxZir®
• Version Model Number: 70-1182-BZE0555
• Catalog Number: 70-1182-BZE0555
• Company DUNS: 022761689
• Company Name: Prismatik Dentalcraft, Inc
• Device Count: 40
• 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

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D745701182BZE05550 [Primary]
HIBCC	D745701182BZE05552 [Unit of Use]

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: 2024-06-17
• Device Publish Date: 2024-06-07

On-Brand Devices [BruxZir®]

• D745701184RAD0048: BruxZir® Radiant - 400 22mm - GD
• D745701184RAD0047: BruxZir® Radiant - 400 20mm - GD
• D745701184RAD0046: BruxZir® Radiant - 400 16mm - GD
• D745701184RAD0045: BruxZir® Radiant - 400 14mm - GD
• D745701184RAD0044: BruxZir® Radiant - 300 22mm - GD
• D745701184RAD0043: BruxZir® Radiant - 300 20mm - GD
• D745701184RAD0042: BruxZir® Radiant - 300 16mm - GD
• D745701184RAD0041: BruxZir® Radiant - 300 14mm - GD
• D745701184RAD0040: BruxZir® Radiant - 200 22mm - GD
• D745701184RAD0039: BruxZir® Radiant - 200 20mm - GD
• D745701184RAD0038: BruxZir® Radiant - 200 16mm - GD
• D745701184RAD0037: BruxZir® Radiant - 200 14mm - GD
• D745701184RAD0036: BruxZir® Radiant - 100 22mm - GD
• D745701184RAD0035: BruxZir® Radiant - 100 20mm - GD
• D745701184RAD0034: BruxZir® Radiant - 100 16mm - GD
• D745701184RAD0033: BruxZir® Radiant - 100 14mm - GD
• D745701184RAD0032: BruxZir® Radiant - White 22mm - GD
• D745701184RAD0031: BruxZir® Radiant - White 20mm - GD
• D745701184RAD0030: BruxZir® Radiant - White 16mm - GD
• D745701184RAD0029: BruxZir® Radiant - White 14mm - GD
• D745701184RAD0028: BruxZir® Radiant - Brite 22mm - GD
• D745701184RAD0027: BruxZir® Radiant - Brite 20mm - GD
• D745701184RAD0026: BruxZir® Radiant - Brite 16mm - GD
• D745701184RAD0025: BruxZir® Radiant - Brite 14mm - GD
• D745701184RAD0024: BruxZir® Radiant - 400 22mm
• D745701184RAD0023: BruxZir® Radiant - 400 20mm
• D745701184RAD0022: BruxZir® Radiant - 400 16mm
• D745701184RAD0021: BruxZir® Radiant - 400 14mm
• D745701184RAD0020: BruxZir® Radiant - 300 22mm
• D745701184RAD0019: BruxZir® Radiant - 300 20mm
• D745701184RAD0018: BruxZir® Radiant - 300 16mm
• D745701184RAD0017: BruxZir® Radiant - 300 14mm
• D745701184RAD0016: BruxZir® Radiant - 200 22mm
• D745701184RAD0015: BruxZir® Radiant - 200 20mm
• D745701184RAD0014: BruxZir® Radiant - 200 16mm
• D745701184RAD0013: BruxZir® Radiant - 200 14mm
• D745701184RAD0012: BruxZir® Radiant - 100 22mm
• D745701184RAD0011: BruxZir® Radiant - 100 20mm
• D745701184RAD0010: BruxZir® Radiant - 100 16mm
• D745701184RAD0009: BruxZir® Radiant - 100 14mm
• D745701184RAD0008: BruxZir® Radiant - White 22mm
• D745701184RAD0007: BruxZir® Radiant - White 20mm
• D745701184RAD0006: BruxZir® Radiant - White 16mm
• D745701184RAD0005: BruxZir® Radiant - White 14mm
• D745701184RAD0004: BruxZir® Radiant - Brite 22mm
• D745701184RAD0003: BruxZir® Radiant - Brite 20mm
• D745701184RAD0002: BruxZir® Radiant - Brite 16mm
• D745701184RAD0001: BruxZir® Radiant - Brite 14mm
• D745701182BZE05582: BruxZir Esthetic GL Single Unit Block - White
• D745701182BZE05572: BruxZir Esthetic GL Single Unit Block - Bleach