Identity
- Trade Name
- VINTAGE PRO POWD OPAQ W2O 15G FDA UDI
- Generic Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Device Name
- VINTAGE PRO POWD OPAQ W2O 15G FDA UDI
- Model / Reference
- P0050 FDA UDI
- Description
- VINTAGE PRO POWD OPAQ W2O 15G FDA UDI
Identifiers
- Catalog Number
- P0050 FDA UDI
- Primary DI / UDI-DI
- E235P00500 FDA UDI
- 510(k) Number
- K181496 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
The VINTAGE PRO POWD OPAQ W2O 15G dental porcelain/ceramic restoration kit is a reusable device used in the production of artificial teeth, crowns, and bridges. This device is designed for use in the dental laboratory and features a collection of containers with different shades of porcelain.
Similar devices
Also classified as Dental porcelain/ceramic restoration kit.
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Cleared under the same submission
K181496 also covers:
- VINTAGE PRO A3 PASTE OPAQUE SE — SHOFU DENTAL CORP.
- VINTAGE PRO BODY A1B 50G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY A4B 15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY B1B 50G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY B2B 50G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY B3B 15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY B3B 50G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY D2B 15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY D4B15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY W1B 15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY W3B 15G — SHOFU DENTAL CORP.
- VINTAGE PRO BODY W3B 50G — 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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Shofu Dental Corp.
Sources (1)
- FDA UDI f8187cf7-ecc7-472c-9454-70c706bf4600 36 fields · synced Jul 31, 2026