AccessGUDID - DEVICE: EASE-IT (05713513001000)

GUDID

Device Identifier (DI) Information

Brand Name: EASE-IT
Version or Model: 20020
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Rønvig Dental Manufacturing A/S

Primary DI Number: 05713513001000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 307549241 *Terms of Use

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

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	Yes
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EEG	Heat Source For Bleaching Teeth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 5a9e8d81-f70d-45c8-8361-d040db3c3ed0
Public Version Date: October 06, 2022
Public Version Number: 1
DI Record Publish Date: September 28, 2022