VINTAGE GUMMY SHADE GUIDE

Basic Information

• Brand Name: VINTAGE GUMMY SHADE GUIDE
• Primary DI: E23596220
• Version / Model: 9622
• Catalog Number: 9622
• Company Name: SHOFU DENTAL CORPORATION
• Labeler DUNS: 054618202
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2025-07-24
• Public Version: 1
• Public Version Date: 2025-08-01
• Public Version Status: New
• Public Device Record Key: 0e6865c3-c5f2-404f-ae37-0d8e5ca4d23f

Device Description

Dental Shade Guide

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: No
• Has Lot/Batch Number: Yes
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
EIH	Powder, Porcelain	Dental	872.6660	2

GMDN Terms

Code	Name	Definition	Implantable	Status
38651	Dental shade guide	A device used to determine the correct shade (colour) of filling materials, artificial crowns, and teeth to match the patient's dentition.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	E23596220	HIBCC

Customer Contacts

• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K093559	000