AccessGUDID - DEVICE: CORiTEC PMMA Disc (D70952500598217)

GUDID

Device Identifier (DI) Information

Brand Name: CORiTEC PMMA Disc
Version or Model: CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL2, with notch
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 52500598217
Company Name: Merz Dental GmbH

Primary DI Number: D70952500598217
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 324914910 *Terms of Use

Device Description: CORiTEC PMMA Disc thickness 20mm, diameter 98,5mm, shade BL2, with notch

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?
31783	Temporary dental crown/bridge	A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EBG	Crown And Bridge, Temporary, Resin

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K071548	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
Outer Diameter: 98.5 Millimeter
Height: 20 Millimeter

Device Record Status

Public Device Record Key: 14fa322e-8d17-448b-a669-7bb527a29d78
Public Version Date: January 27, 2025
Public Version Number: 5
DI Record Publish Date: September 30, 2017