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Grandio Seal
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1060510(k) K062344
by VOCO GmbH
Identity
- Trade Name
- Grandio Seal FDA UDI
- Generic Name
- Dental unfilled resin sealant/coating FDA UDI
- Device Name
- Grandio Seal EUDAMEDGrandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties. FDA UDI
- Model / Reference
- 1060 EUDAMEDFDA UDI
- Description
- Grandio® Seal is a light-curing, highly filled, fluoride-containing nanohybrid fissure sealant with outstanding mechanical properties. FDA UDI
Identifiers
- Catalog Number
- 1060 FDA UDI
- Primary DI / UDI-DI
- E22110601 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210163000000000BP EUDAMED
- 510(k) Number
- K062344 FDA UDI
- FDA Product Code
- EBC FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental unfilled resin sealant/coating FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3765 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
Category: Dental composite resin
Grandio Seal by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K062344 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210163000000000BP | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED 48cce33b-e6be-456f-ae29-4eb813e6366d 85 fields · synced Jun 18, 2026
- FDA UDI e6b24c94-586b-4031-9946-91a5fade0478 37 fields · synced May 30, 2026
- FDA 510(k) K062344 1 fields · synced May 18, 2026