AccessGUDID - DEVICE: Vericore Gradient Temp (D040724781)

GUDID

Device Identifier (DI) Information

Brand Name: Vericore Gradient Temp
Version or Model: A3 Shade
Commercial Distribution Status: Not in Commercial Distribution
Catalog Number: 72478
Company Name: WHIP-MIX CORPORATION

Primary DI Number: D040724781
Issuing Agency: HIBCC
Commercial Distribution End Date: May 31, 2019
Device Count: 1
Labeler D-U-N-S® Number*: 006385173 *Terms of Use

Device Description: Vericore ® Gradient Temporary discs is a device made from Polymethylmethacrlate. It is used to mill/fabricate temporary crown or bridge for use in the oral cavity for up to six (6) months while awaiting a permanent restoration. Restorations are designed virtually by a dental professional/technician then manufactured (milled) using CAD technology

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?
45236	Temporary dental crown/bridge resin	A material [e.g., polymethylmethacrylate (PMMA)] intended to make a temporary crown or bridge prosthesis for use until a permanent restoration is fabricated.	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 [?]
K132937	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
Device Size Text, specify: 12mm X 98mm

Device Record Status

Public Device Record Key: 1749494b-b32a-46d9-aa52-ccaabe77d829
Public Version Date: October 29, 2021
Public Version Number: 5
DI Record Publish Date: August 29, 2016