AccessGUDID - DEVICE: Vericore ZR Pro ML (D040745201)

GUDID

Device Identifier (DI) Information

Brand Name: Vericore ZR Pro ML
Version or Model: 74520
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 74520
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040745201
Issuing Agency: HIBCC
Commercial Distribution End Date: February 25, 2021
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines. Vericore zirconia blanks are biocompatible and designed to fabricate; - Zirconia Substructures - Restorations (Including inlays, onlays, and veneers) - Crown Framework in the Anterior and Posterior regions - Bridge Framework in the Anterior and Posterior regions

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?
38594	Custom-made dental crown, ceramic	A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	Powder, Porcelain

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
Width: 22 Millimeter

Device Record Status

Public Device Record Key: cc25d942-3404-4a20-aae7-42a4b3214498
Public Version Date: August 26, 2021
Public Version Number: 3
DI Record Publish Date: May 03, 2019