Premier Universal Primer Sample

GUDID D6913001569

Primer Sample

PREMIER DENTAL PRODUCTS COMPANY

Dentine bonding agent/set

• Primary Device ID: D6913001569
• NIH Device Record Key: 9d7d4a11-22b0-4148-812b-373e90f737de
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Premier Universal Primer Sample
• 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: 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	D6913001569 [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

Devices Manufactured by PREMIER DENTAL PRODUCTS COMPANY

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• 00348783003536 - Cure-Thru Integra Post: 2024-09-27 Cure-Thru Integra Post (10)- Size 4.5
• 00348783003543 - Cure-Thru Integra Post: 2024-09-27 Cure-Thru Integra Post (10)- Size 5
• 00348783003550 - Cure-Thru Integra Post: 2024-09-27 Cure-Thru Integra Post (10)- Size 6
• 10348783005599 - Enamel Pro Varnish: 2024-09-27 EP Varnish Straw 'N Cream .40 ml (35)
• 10348783005605 - Enamel Pro Varnish: 2024-09-27 EP Varnish Bubblegum .40 ml (35)
• 10348783005612 - Enamel Pro Varnish: 2024-09-27 EP Varnish Bubblegum .25 ml (35)
• 10348783005629 - Enamel Pro Varnish: 2024-09-27 EP Varnish Straw 'N Cream .40 ml (200)