Identity
- Trade Name
- Grandio Flow FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Grandio Flow EUDAMEDExcellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material. Contains: Shade A1, A2, A3, A3.5, B1, BL, WO shade guide FDA UDI
- Model / Reference
- 1860 EUDAMEDFDA UDI
- Description
- Excellent physical properties for long-lasting restorations. Significantly lower polymerisation shrinkae than conventional composites. High filler content of 87 % w/w. Extremely high abrasion resistance. High transverse strength. Smooth consistency for convenient handling. Shade guide made from original material. Contains: Shade A1, A2, A3, A3.5, B1, BL, WO shade guide FDA UDI
Identifiers
- Catalog Number
- 1860 FDA UDI
- Primary DI / UDI-DI
- E22118601 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210164000000000CL 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
- 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
Yes
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
Grandio Flow by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051868 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K033117 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K101213 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210164000000000CL | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED 2150ec36-2f3a-4c3c-8cfd-91e0792c0976 61 fields · synced Jul 17, 2026
- FDA UDI 0cc7bc47-7086-4fbc-8f68-7767bae380b7 36 fields · synced May 30, 2026
- FDA 510(k) K051868 1 fields · synced May 18, 2026