Enamel Pro® Prophy Paste

Basic Information

• Brand Name: Enamel Pro® Prophy Paste
• Primary DI: 00348783005301
• Version / Model: 9007611
• Company Name: PREMIER DENTAL PRODUCTS COMPANY
• Labeler DUNS: 014789663
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-16
• Public Version: 1
• Public Version Date: 2025-07-24
• Public Version Status: New
• Public Device Record Key: 2b333a13-815b-4a3d-8ebc-c3570742cc85

Device Description

Enamel Pro® Prophy Paste Grape-Medium

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: Yes
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EJR	Agent, Polishing, Abrasive, Oral Cavity	Dental	872.6030	1

GMDN Terms

Code	Name	Definition	Implantable	Status
11168	Dentifrice	A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	00348783012989	GS1	case	10	In Commercial Distribution
Primary	00348783005301	GS1

Premarket Submissions

Submission Number	Supplement Number
K062166	000