Identity
- Trade Name
- Vittra APS Caps DA0 EUDAMEDVittra APS FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Vittra APS EUDAMEDVittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. FDA UDI
- Model / Reference
- 4000021677 EUDAMEDDA0 0.2g - caps FDA UDI
- Description
- Vittra APS is a highly aesthetic light-curing composite resin recommended for restorations of all classes in anterior and posterior teeth. FDA UDI
Identifiers
- Catalog Number
- 4000021677 FDA UDI
- Primary DI / UDI-DI
- 07899633822362 EUDAMEDFDA UDI
- Basic UDI-DI
- 78996338RST008AE EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3690 FDA UDI
- Market of Registration
- Portugal EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
Yes
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
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
Vittra APS by Dentscare Ltda — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Dentscare Ltda
Sources (2)
- FDA UDI f895954d-4dc1-4721-b8b5-f0f8243600f8 34 fields · synced Jul 24, 2026
- EUDAMED b66a324e-0ade-45d7-86c3-54edcbfe97a6 61 fields · synced Jul 24, 2026