Zen

Basic Information

• Brand Name: Zen
• Primary DI: D813ZENCPMT61
• Version / Model: ZENCPMT6
• Catalog Number: ZENCPMT6
• Company Name: DEN-MAT HOLDINGS, LLC
• Labeler DUNS: 809857704
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 6
• Record Status: Published
• Publish Date: 2022-09-22
• Public Version: 1
• Public Version Date: 2022-09-30
• Public Version Status: New
• Public Device Record Key: 0594d7f7-753a-4415-9207-aac65dc8ece4

Device Description

ZEN MINT GEL 6pc

Device Characteristics

• Single Use: Yes
• Prescription Use (Rx): No
• Over the Counter (OTC): Yes
• 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
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
Unit of Use	D813ZENCPMT60	HIBCC
Primary	D813ZENCPMT61	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]