ZR-Cem

GUDID 00348783000580

ZR-Cem Shade A2

PREMIER DENTAL PRODUCTS COMPANY

Dental composite resin

• Primary Device ID: 00348783000580
• NIH Device Record Key: 3449589e-3c51-40e3-a6ad-62479ef752c7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: ZR-Cem
• Version Model Number: 3001561
• Company DUNS: 014789663
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• 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: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: true
• 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
GS1	00348783000580 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150601

FDA Product Code

• EMA: Cement, Dental

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: 2023-10-24
• Device Publish Date: 2023-10-16

On-Brand Devices [ZR-Cem]

• 00348783000610: ZR-Cem Shade Translucent Sample
• 00348783000597: ZR-Cem Shade Translucent
• 00348783000580: ZR-Cem Shade A2
• 00348783000573: ZR-Cem Shade White