AccessGUDID - DEVICE: EVOFILL DUO (08806383554909)

GUDID

Device Identifier (DI) Information

Brand Name: EVOFILL DUO
Version or Model: HEATING CONDENSER (#F / #FM)
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 4005-2075
Company Name: DiaDent Group International

Primary DI Number: 08806383554909
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

Device Description: EvoFill Duo(Gutta percha obturation System) is an electrically powered dental device used for heating Gutta percha and placing the softened material in prepared root canals of teeth during root canal therapy.

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):	Yes
Over the Counter (OTC):	No
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?
45247	Endodontic obturation system	An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKR	Plugger, Root Canal, Endodontic

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: Yes
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between 0 and 40 Degrees Celsius
Storage Environment Humidity: between 30 and 85 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 54ed7027-3a96-44a0-8342-1123ce7f02be
Public Version Date: June 03, 2020
Public Version Number: 1
DI Record Publish Date: May 26, 2020