AccessGUDID - DEVICE: PRO3DURE GR-21 Try-In (EPRCD1001602)

GUDID

Device Identifier (DI) Information

Brand Name: PRO3DURE GR-21 Try-In
Version or Model: 1kg ; Color:A2
Commercial Distribution Status: In Commercial Distribution
Catalog Number: D1001602
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCD1001602
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: printodent GR-21 Try-In 1kg ; Color:A2

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?
34808	Dental base plate	A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EEA	Plate, Base, Shellac

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: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: b0334509-b547-4fd0-828e-5a9e9f375137
Public Version Date: September 20, 2022
Public Version Number: 1
DI Record Publish Date: September 12, 2022