PractiPro Mint TCP Prophy Paste Coarse

Basic Information

• Brand Name: PractiPro Mint TCP Prophy Paste Coarse
• Primary DI: 00723896021262
• Version / Model: 7159810 coa
• Catalog Number: 7159810 coa
• Company Name: PRACTICON, INC.
• Labeler DUNS: 119193803
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-05-27
• Public Version: 1
• Public Version Date: 2022-06-06
• Public Version Status: New
• Public Device Record Key: fce73b8a-72e3-47a6-a08d-4c6bcf207916

Device Description

Coarse Grit Mint Prophy Paste with TCP

Device Characteristics

• Single Use: Yes
• 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: 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
38785	Dental bleaching agent	A dental liquid solution or a paste used to whiten teeth for therapeutic or cosmetic purposes. 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	00723896021279	GS1	case	5	In Commercial Distribution
Primary	00723896021262	GS1

Premarket Submissions

Submission Number	Supplement Number
K062166	000