AccessGUDID - DEVICE: PRO3DURE GR-17.1 temporary lt (EPRCD1001625)

GUDID

Device Identifier (DI) Information

Brand Name: PRO3DURE GR-17.1 temporary lt
Version or Model: 500g - B2
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCD1001625
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: No description.

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?
38643	Resin artificial teeth	Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PZY	Additively Manufactured, Preformed, Resin Denture Tooth

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201827	000

Device Exempt from Premarket Submission: No 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 18 and 28 Degrees Celsius
Special Storage Condition, Specify: Keep away from sunlight

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 740b9f09-6bc1-49f0-b40a-83d0db5fc88c
Public Version Date: November 26, 2020
Public Version Number: 1
DI Record Publish Date: November 18, 2020