Premier Universal Primer

GUDID 00348783000634

Premier Universal Primer Sample

PREMIER DENTAL PRODUCTS COMPANY

Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent Dental prosthesis priming agent

• Primary Device ID: 00348783000634
• NIH Device Record Key: 9d7d4a11-22b0-4148-812b-373e90f737de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Universal Primer
• Version Model Number: 3001569
• 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: 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	00348783000634 [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: Update
• Device Record Status: Published
• Public Version Number: 2
• Public Version Date: 2023-10-17
• Device Publish Date: 2020-02-25

On-Brand Devices [Premier Universal Primer]

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