Identity
- Trade Name
- VINTAGE OPAL FDA UDI
- Generic Name
- Dental porcelain/ceramic restoration kit FDA UDI
- Device Name
- VINTAGE OPAL STARTER KIT B3 FDA UDI
- Model / Reference
- 6904 FDA UDI
- Description
- VINTAGE OPAL STARTER KIT B3 FDA UDI
Identifiers
- Catalog Number
- 6904 FDA UDI
- Primary DI / UDI-DI
- E23569040 FDA UDI
- 510(k) Number
- K884214 FDA UDI
- FDA Product Code
- ELL FDA UDI
- GMDN Term
- Dental porcelain/ceramic restoration kit FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3920 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
Vintage Opal 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
K884214 also covers:
- Lamina Porcelain — SHOFU DENTAL CORP.
- Lamina Porcelain — SHOFU DENTAL CORP.
- VINTAGE OPAL — SHOFU DENTAL CORP.
- VINTAGE OPAL — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — SHOFU DENTAL CORP.
- Vintage — 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 0b0314bb-37f7-448b-96b7-365f5d31172d 36 fields · synced May 30, 2026