Enamel Pro Varnish

GUDID 10348783005612

EP Varnish Bubblegum .25 ml (35)

PREMIER DENTAL PRODUCTS COMPANY

Dental coating, tooth-desensitizing, professional

• Primary Device ID: 10348783005612
• NIH Device Record Key: 20ed4533-4c2b-4f9a-831e-992f7a80beeb
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamel Pro Varnish
• Version Model Number: 9007542
• 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	00348783005615 [Primary]
GS1	10348783005612 [Package]; Contains: 00348783005615; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062683

FDA Product Code

• LBH: Varnish, Cavity

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: 2024-09-27
• Device Publish Date: 2024-09-19

On-Brand Devices [Enamel Pro Varnish]

• 00348783005677: ENAMEL PRO VARNISH SAMPLE
• 10348783005667: HS GKAS EPV Bubblegum .40 ml (50 cups)
• 10348783005650: EP Varnish VanillaMint .40 ml (35)
• 10348783005643: EP Varnish VanillaMint .40 ml (200)
• 10348783005636: EP Varnish Bubblegum .40 ml (200)
• 10348783005629: EP Varnish Straw 'N Cream .40 ml (200)
• 10348783005612: EP Varnish Bubblegum .25 ml (35)
• 10348783005605: EP Varnish Bubblegum .40 ml (35)
• 10348783005599: EP Varnish Straw 'N Cream .40 ml (35)