Monolith Prophy Paste SENSO "Spearmint" Tube

Basic Information

• Brand Name: Monolith Prophy Paste SENSO "Spearmint" Tube
• Primary DI: 04064896000151
• Version / Model: M501
• Company Name: PRISMAN INC.
• Labeler DUNS: 117569946
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-10-10
• Public Version: 1
• Public Version Date: 2021-10-18
• Public Version Status: New
• Public Device Record Key: 278ef930-887c-4e55-8ec4-fc30969adb2d

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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	Dental abrasive powder	A dental material made from various base substances having some abrasive qualities [e.g., treated sodium bicarbonate (NaHCO3) or aluminium oxide (Al2O3)] and applied with an appropriate device (e.g., a dental abrasive air jet system) to the surface of teeth or dental devices. 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, the cleaning of orthodontic appliances (bands and brackets), the removal of adhesive residue, and the cleaning of 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
Primary	04064896000151	GS1