Enamel Pro® Prophy Paste

GUDID 00348783005196

Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free

PREMIER DENTAL PRODUCTS COMPANY

Dentifrice

• Primary Device ID: 00348783005196
• NIH Device Record Key: 257bf33e-520a-4ac2-ae91-5a469fdef5fe
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Enamel Pro® Prophy Paste
• Version Model Number: 9007613
• 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	00348783005196 [Primary]
GS1	00348783013009 [Package]; Package: case [10 Units]; In Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K062166

FDA Product Code

• EJR: Agent, Polishing, Abrasive, Oral Cavity

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: 2025-07-17
• Device Publish Date: 2022-06-29

On-Brand Devices [Enamel Pro® Prophy Paste]

• 00348783005400: Enamel Pro® Prophy Paste Mixed Berry-Coarse
• 00348783005394: Enamel Pro® Prophy Paste Mixed Berry-Medium
• 00348783005387: Enamel Pro® Prophy Paste Mixed Berry-Fine
• 00348783005370: Enamel Pro® Prophy Paste Cinnamon-Coarse
• 00348783005363: Enamel Pro® Prophy Paste Cinnamon-Medium
• 00348783005356: Enamel Pro® Prophy Paste Cinnamon-Fine
• 00348783005349: Enamel Pro® Prophy Paste Strawberry-Coarse
• 00348783005332: Enamel Pro® Prophy Paste Strawberry-Medium
• 00348783005325: Enamel Pro® Prophy Paste Strawberry-Fine
• 00348783005318: Enamel Pro® Prophy Paste Grape-Coarse
• 00348783005295: Enamel Pro® Prophy Paste Grape-Fine
• 00348783005288: Enamel Pro® Prophy Paste Bubblegum-Coarse
• 00348783005271: Enamel Pro® Prophy Paste Bubblegum-Medium
• 00348783005264: Enamel Pro® Prophy Paste Bubblegum-Fine
• 00348783005257: Enamel Pro® Prophy Paste Raspberry Mint-Coarse (Box of 200)
• 00348783005240: Enamel Pro® Prophy Paste Raspberry Mint-Medium
• 00348783005233: Enamel Pro® Prophy Paste Raspberry Mint-Fine
• 00348783005226: Enamel Pro® Prophy Paste Vanilla mint-Coarse
• 00348783005219: Enamel Pro® Prophy Paste Vanilla mint-Medium
• 00348783005202: Enamel Pro® Prophy Paste Vanilla mint-Fine
• 00348783005196: Enamel Pro® Prophy Paste Mint-Coarse-Fluoride free
• 00348783005189: Enamel Pro® Prophy Paste Mint-Extra Coarse
• 00348783005172: Enamel Pro® Prophy Paste Mint-Coarse
• 00348783005165: Enamel Pro® Prophy Paste Mint-Medium
• 00348783005158: Enamel Pro® Prophy Paste Mint-Fine (Box of 200)
• 00348783012989: Enamel Pro® Prophy Paste Grape-Medium