EASE-IT

Basic Information

• Brand Name: EASE-IT
• Primary DI: 05713513001000
• Version / Model: 20020
• Company Name: Rønvig Dental Manufacturing A/S
• Labeler DUNS: 307549241
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2022-09-28
• Public Version: 1
• Public Version Date: 2022-10-06
• Public Version Status: New
• Public Device Record Key: 5a9e8d81-f70d-45c8-8361-d040db3c3ed0

Device Description

Heating Unit with electronic temperature control, 40° - 60°C / 104°- 140°F, designed for warming up dental composite materials.

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: Yes
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• 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
EEG	Heat Source For Bleaching Teeth	Dental	872.6475	1

GMDN Terms

Code	Name	Definition	Implantable	Status
65223	Dental material heater	An electrically-powered device designed to be used to heat, through conduction, a variety of materials/substances (e.g., composite resin, root canal cleaning solution, local anaesthetic agent) to facilitate application of the material (e.g., optimum performance, patient comfort) during a dental procedure. It consists of a heating element with a temperature controller and a heater plate.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05713513001000	GS1