AccessGUDID - DEVICE: Profibase (E22121141)

GUDID

Device Identifier (DI) Information

Brand Name: Profibase
Version or Model: 2114
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 2114
Company Name: VOCO GmbH

Primary DI Number: E22121141
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 2
Labeler D-U-N-S® Number*: 316699578 *Terms of Use

Device Description: Profibase is a light-curing resin in pre-contoured plates for maxillae and mandibles for the fabrication of individual impression and functional trays for use in crown, bridge and total prosthetic technique to be used for the fabrication of bases of bite patterns as well as for dimensionally stable base plates for wax contouring in the total prosthetic technique. The material is ready for use and easy to handle.

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?
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
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: 1485a637-6368-4ebd-b7d6-8a714e4fd57c
Public Version Date: June 14, 2019
Public Version Number: 1
DI Record Publish Date: June 06, 2019