AccessGUDID - DEVICE: Elements Gutta Percha Cartridge 10 PCS (08809455601730)

GUDID

Device Identifier (DI) Information

Brand Name: Elements Gutta Percha Cartridge 10 PCS
Version or Model: Gutta Percha, Light body 25 Gauge
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 972-2501
Company Name: META SYSTEMS CO., LTD.

Primary DI Number: 08809455601730
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687503532 *Terms of Use

Device Description: The Elements™ Gutta Percha Cartridge (The Gutta Percha Cartridge) is a device that contains gutta-percha material. It is used in conjunction with the Backfill Unit of elements™ IC obturation device or with the Extruder Handpiece of the elements Obturation Unit™. The gutta-percha material is heated and extruded from the cartridge to obturate the root canal as part of an endodontic treatment procedure. The Gutta Percha Cartridge is available in Light 25 gauge, and Medium, Heavy body in 23 gauge.

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:	Yes
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?
31872	Natural gutta-percha	A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EKM	Gutta-Percha

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: c263848b-54e0-47ad-a2e5-bb7464eb62fc
Public Version Date: January 07, 2025
Public Version Number: 1
DI Record Publish Date: December 30, 2024