AccessGUDID - DEVICE: Durabase

GUDID

Device Identifier (DI) Information

Brand Name: Durabase - Pink
Version or Model: 1401
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: Reliance Dental Manufacturing Co Inc

Primary DI Number: D9471401
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 005139159 *Terms of Use

Device Description: Denture relining material/4 OZ. POWDER / 4 OZ. LIQUID / 8.5 cc Liquid (113 GR POWDER / 118 ML LIQUID)

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):	No
Over the Counter (OTC):	No
Kit:	Yes
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?
58106	Dental impression tray material	A material intended to be used to create a custom impression tray intended for filling with dental impression materials; it is not intended for the fabrication of a patient-worn dental appliance. The tray is typically made by applying the material to a preliminary plaster or stone model of the patient's teeth and gums. The material is used in cases in which a preformed impression tray is not suitable. This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBH	Material, Impression Tray, Resin

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: 4c0c07eb-fc75-48ee-b4d6-8977f67c088d
Public Version Date: January 23, 2023
Public Version Number: 1
DI Record Publish Date: January 13, 2023