Identity
- Trade Name
- GrandioSO x-tra FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Syringe 4g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterised by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDI
- Model / Reference
- 2596 FDA UDI
- Description
- Syringe 4g A1 GrandioSO x-tra is a light-curing, radiopaque nano-hybrid restorative material. It is characterised by an increased depth of cure while at the same time showing reduced shrinkage stress, which means that it can be cured in layers of 4 mm thickness. FDA UDI
Identifiers
- Catalog Number
- 2596 FDA UDI
- Primary DI / UDI-DI
- E22125961 FDA UDI
- 510(k) Number
- K181312 FDA UDI
- FDA Product Code
- EBF FDA UDI
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 872.3690 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 composite resin
GrandioSO x-tra by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Cleared under the same submission
K181312 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
- VOCO GmbH
Sources (1)
- FDA UDI ecaea973-800d-4146-bd31-c0f03873f574 36 fields · synced May 30, 2026