FDA UDI In Commercial Distribution 🇺🇸 United States

VINTAGE Art Universal

DI: 04548162267337 · Model: P0704 · SHOFU DENTAL CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
2
Pkg Device Count
1

Basic Information

Brand Name
VINTAGE Art Universal
Primary DI
04548162267337
Version / Model
P0704
Catalog Number
P0704
Company Name
SHOFU DENTAL CORPORATION
Labeler DUNS
054618202
Distribution Status
In Commercial Distribution
Device Count in Pkg
1
Record Status
Published
Publish Date
2026-04-10
Public Version
1
Public Version Date
2026-04-20
Public Version Status
New
Public Device Record Key
01bbb105-c634-44e0-8dc9-2c201c119a09

Device Description

VINTAGE Art Universal 2g O

Device Characteristics

Single Use
No
Prescription Use (Rx)
Yes
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
Yes
Has Expiration Date
Yes
Has Donation ID
No

Sterilization

Is Sterile
No
Sterilization Prior Use
No

Product Codes

Code Name
EIH POWDER, PORCELAIN

GMDN Terms

Code Name
44727 Dental porcelain/ceramic restoration kit

Identifiers

Type ID
Direct Marking 84548162267333
Primary 04548162267337

Customer Contacts

Premarket Submissions

Submission Number Supplement Number
K191794 000

Storage Conditions

Type
Storage Environment Temperature
Temperature Range
1 – 30 Degrees Celsius