Identity
- Trade Name
- GrandioSO Flow EUDAMEDGrandio SO Flow FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- GrandioSO Flow EUDAMEDFlowable universal nano-hybrid restorative material FDA UDI
- Model / Reference
- 2724 EUDAMEDFDA UDI
- Description
- Flowable universal nano-hybrid restorative material FDA UDI
Identifiers
- Catalog Number
- 2724 FDA UDI
- Primary DI / UDI-DI
- E22127241 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210157000000000EC EUDAMED
- 510(k) Number
- K103580 FDA UDI
- 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
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
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
No
FDA UDI
Grandio SO Flow by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Cleared under the same submission
K103580 also covers:
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
- Grandio SO Flow — VOCO GmbH
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 (2)
- FDA UDI 4aa87757-cc50-4369-89a1-fe99c36d2317 37 fields · synced Oct 7, 2026
- EUDAMED deb04b65-4698-4d28-8ca0-eff9ecb84349 61 fields · synced Jul 13, 2026