Premier Universal Primer

GUDID D6913001568

Primer

PREMIER DENTAL PRODUCTS COMPANY

Dentine bonding agent/set

• Primary Device ID: D6913001568
• NIH Device Record Key: c1b848ff-9113-4ef1-aca3-dc53082585fa
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Universal Primer
• Version Model Number: 3001568
• 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: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• 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
HIBCC	D6913001568 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131212

FDA Product Code

• KLE: Agent, Tooth Bonding, Resin

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: 2020-03-04
• Device Publish Date: 2020-02-25

On-Brand Devices [Premier Universal Primer]

• D6913001568: Primer
• 00348783000634: Premier Universal Primer Sample
• 00348783000627: Premier Universal Primer