Dentek

Basic Information

• Brand Name: Dentek
• Primary DI: 00050428373262
• Version / Model: 00015101203I2
• Company Name: DenTek Oral Care, Inc.
• Labeler DUNS: 153818646
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2020-08-07
• Public Version: 3
• Public Version Date: 2023-11-29
• Public Version Status: Update
• Public Device Record Key: 67789d48-77b9-4a89-b6b6-396caad01755

Device Description

DNTL GRD SUPERIOR CMF NO BOIL 2CT CVS 12

Device Characteristics

• Single Use: No
• 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: No
• Has Serial Number: Yes
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBR	Mouthguard, Over-The-Counter	Unknown		U

GMDN Terms

Code	Name	Definition	Implantable	Status
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Package	30050428373263	GS1	Single	1	In Commercial Distribution
Primary	00050428373262	GS1

Customer Contacts

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