AccessGUDID - DEVICE: PRO3DURE THERMEO Blank (EPRCD1010127)

GUDID

Device Identifier (DI) Information

Brand Name: PRO3DURE THERMEO Blank
Version or Model: color A3, height 20 mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: pro3dure medical GmbH

Primary DI Number: EPRCD1010127
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 312947842 *Terms of Use

Device Description: THERMEO Blank, diameter 98.5 mm, height 20 mm

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):	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?
38620	Custom-made mouthguard	A custom-made oral device designed to protect the teeth, bones, and tissues of the mouth from damage due to impact/trauma typically during contact sports, and/or to prevent teeth grinding/clenching (bruxism). It is custom-made for a specified patient from impressions of the dental arch. Some types are referred to as nightguards or bite raising appliances. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
MQC	Mouthguard, Prescription

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K212017	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
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 6d9d02df-0011-4b98-a8ff-c7a562a6f729
Public Version Date: April 21, 2022
Public Version Number: 1
DI Record Publish Date: April 13, 2022