AccessGUDID - DEVICE: Vortex Gutta Percha Points (D716VXGP04151)

GUDID

Device Identifier (DI) Information

Brand Name: Vortex Gutta Percha Points
Version or Model: VXGP0415
Commercial Distribution Status: In Commercial Distribution
Catalog Number: VXGP0415
Company Name: TULSA DENTAL PRODUCTS LLC

Primary DI Number: D716VXGP04151
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 942778564 *Terms of Use

Device Description: Vortex Gp Points 04/15

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):	Yes
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	Yes
Prescription Use (Rx):	No
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: Yes

Sterilization Method [?]
Liquid Chemical

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: 2bf30d13-10d0-4c9b-8532-9281087278ca
Public Version Date: November 04, 2022
Public Version Number: 1
DI Record Publish Date: October 27, 2022