Denta-Cool

Basic Information

• Brand Name: Denta-Cool
• Primary DI: 10860001416722
• Version / Model: 100-0005
• Company Name: CHEMOMOUTHPIECE, LLC
• Labeler DUNS: 116840035
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2024-05-22
• Public Version: 1
• Public Version Date: 2024-05-30
• Public Version Status: New
• Public Device Record Key: a3705a28-194c-470e-b0d6-1e798b0438d2
• Distribution End Date: 2024-05-22

Device Description

Intraoral Cryotherapy Device

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
KYR	Bag, Ice	General Hospital	880.6050	1

GMDN Terms

Code	Name	Definition	Implantable	Status
46266	Dental cryoanaesthesia mouthpiece	A dental brace-like device designed to be chilled to freezing/subfreezing temperatures and then applied to the labial sulci (gums) in a patient's mouth for a period to provide a cold anaesthesia to reduce pain during a dental procedure. It is typically made of a thermoplastic elastomer (TPE) and cryogenic materials. This is a single-use device.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	10860001416722	GS1
Package	20860001416729	GS1	Box	8	Not in Commercial Distribution	2024-01-01
Package	30860001416726	GS1	Box	1	Not in Commercial Distribution	2024-01-01

Customer Contacts

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