Identity
- Trade Name
- VINT ART UNIV 50G GLAZE FLUO FDA UDI
- Generic Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Device Name
- VINT ART UNIV 50G GLAZE FLUO FDA UDI
- Model / Reference
- P0694 FDA UDI
- Description
- VINT ART UNIV 50G GLAZE FLUO FDA UDI
Identifiers
- Catalog Number
- P0694 FDA UDI
- Primary DI / UDI-DI
- E235P06940 FDA UDI
- 510(k) Number
- K191794 FDA UDI
- FDA Product Code
- EIH FDA UDI
- GMDN Term
- Dental porcelain/ceramic restoration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.6660 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Dental porcelain/ceramic restoration kit
Vint Art Univ 50g Glaze Fluo by Shofu Dental Corp. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Dental porcelain/ceramic restoration kit.
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Cleared under the same submission
K191794 also covers:
- VINT ART UNIV 15G GLAZE FLUO — SHOFU DENTAL CORP.
- VINT ART UNIV BASIC COLOR SET — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G BLACK — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G BLUE — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G BROWN — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G GREEN — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G GREY — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G KHAKI — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G ORANGE — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G PINK — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G VANILLA — SHOFU DENTAL CORP.
- VINT ART UNIV STAIN 2G VIOLET — SHOFU DENTAL CORP.
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA UDI 85f1f307-7595-4571-9579-a8e1dbcf612d 36 fields · synced Jun 8, 2026