AccessGUDID - DEVICE: GUTTA PERCHA POINTS (08806383576475)

GUDID

Device Identifier (DI) Information

Brand Name: GUTTA PERCHA POINTS
Version or Model: DIA-45m/m ASST 15/25
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 121-191
Company Name: DiaDent Group International

Primary DI Number: 08806383576475
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 687789453 *Terms of Use

Device Description: Gutta Percha Points is used to root canal filing material.

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?
45081	Synthetic gutta-percha	A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. 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
Storage Environment Temperature: between 2 and 27 Degrees Celsius
Special Storage Condition, Specify: Keep away from flammable and combustible materials and heat
Special Storage Condition, Specify: Keep Dry and away from Sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: acf88d4f-2c50-43fe-9a05-200817b6dbea
Public Version Date: July 05, 2023
Public Version Number: 1
DI Record Publish Date: June 27, 2023