AccessGUDID - DEVICE: WaveOne Gold Conform Fit (D716WGGPCP1)

GUDID

Device Identifier (DI) Information

Brand Name: WaveOne Gold Conform Fit
Version or Model: WGGPCP
Commercial Distribution Status: In Commercial Distribution
Catalog Number: WGGPCP
Company Name: TULSA DENTAL PRODUCTS LLC

Primary DI Number: D716WGGPCP1
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 60
Labeler D-U-N-S® Number*: 942778564 *Terms of Use

Device Description: Conform Fit Gutta Percha Points for Waveone Gold Endodontic Files

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):	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: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Special Storage Condition, Specify: less than 30 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight. Keep dry.

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 29b19fa8-e504-4b2f-855f-8fce2a53e14d
Public Version Date: October 31, 2022
Public Version Number: 2
DI Record Publish Date: June 30, 2021