Ortho Technology®

Basic Information

• Brand Name: Ortho Technology®
• Primary DI: 00190707191177
• Version / Model: 15486
• Company Name: Ortho Organizers, Inc.
• Labeler DUNS: 062165188
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 200
• Record Status: Published
• Publish Date: 2025-10-23
• Public Version: 3
• Public Version Date: 2025-12-30
• Public Version Status: Update
• Public Device Record Key: c4c1da6f-88e9-4bc6-8bb7-af6ce00e687d

Device Description

Prophy Paste 200-2gm cups PROPHYPASTE

Device Characteristics

• Single Use: Yes
• 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: Yes
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• 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
45407	Professional dental abrasive material	A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied by a healthcare professional with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices (e.g., restorations). It has a wide variety of both prophylactic and treatment applications such as the removal of plaque and stains, cleaning fissures (above and below the gingiva), the preparation of a tooth surface prior to bonding, cleaning orthodontic appliances (bands and brackets), removing adhesive residue, and cleaning implants prior to loading. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Unit of Use	10190707191174	GS1
Primary	00190707191177	GS1