AccessGUDID - DEVICE: PEEK BioSolution (D7091018950)

GUDID

Device Identifier (DI) Information

Brand Name: PEEK BioSolution
Version or Model: PEEK BioSolution white diameter 95mm, thickness 10mm
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1018950
Company Name: Merz Dental GmbH

Primary DI Number: D7091018950
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324914910 *Terms of Use

Device Description: PEEK BioSolution white diameter 95mm, thickness 10mm

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:	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?
61718	Preformed dental crown, permanent	A prefabricated prosthetic device designed to function as a permanent artificial covering to partially or fully replace the damaged crown of a tooth. It is made of ceramic and polymer materials and may require minimal fashioning in situ during restorative work. It is available as a single prosthesis or multiple prostheses of various shapes and sizes, and may include one or more try-in prosthesis replicas and other devices intended to assist the restoration procedure (e.g. disposable prosthesis gauge).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBF	Material, Tooth Shade, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

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
Outer Diameter: 95 Millimeter
Height: 10 Millimeter

Device Record Status

Public Device Record Key: 28a8de81-a45f-46c4-99b3-682f292f8b4a
Public Version Date: January 27, 2025
Public Version Number: 3
DI Record Publish Date: February 20, 2018