AccessGUDID - DEVICE: VINTAGE PRO MARGIN CC 50G (E235P01170)

GUDID

Device Identifier (DI) Information

Brand Name: VINTAGE PRO MARGIN CC 50G
Version or Model: P0117
Commercial Distribution Status: In Commercial Distribution
Catalog Number: P0117
Company Name: SHOFU DENTAL CORPORATION

Primary DI Number: E235P01170
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 054618202 *Terms of Use

Device Description: VINTAGE PRO MARGIN CC 50G

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?
44727	Dental porcelain/ceramic restoration kit	A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
EIH	POWDER, PORCELAIN

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K181496	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
No Device Sizes

Device Record Status

Public Device Record Key: 05af0499-50f1-4c5d-9b98-a8eaa033a89d
Public Version Date: February 11, 2021
Public Version Number: 1
DI Record Publish Date: February 03, 2021