Identity
- Trade Name
- Prevue® FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Prevue® Grey Light, Syringe 2.5g FDA UDI
- Model / Reference
- 604104 FDA UDI
- Description
- Prevue® Grey Light, Syringe 2.5g FDA UDI
Identifiers
- Catalog Number
- 604104 FDA UDI
- Primary DI / UDI-DI
- EDEL6041040 FDA UDI
- 510(k) Number
- K894477 FDA UDI
- FDA Product Code
- EMA FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3275 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
Yes
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
Yes
FDA UDI
Category: Dental composite resin
Prevue® by DeltaMed GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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- Llis — Dentscare Ltda · Class II
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Cleared under the same submission
K894477 also covers:
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
- DeltaMed GmbH
Sources (1)
- FDA UDI a8c46d0b-8c3f-433b-a3f5-408b523401e4 36 fields · synced May 30, 2026