Identity
- Trade Name
- Grandio Seal EUDAMEDFDA 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
- 1061 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
- 1061 FDA UDI
- Primary DI / UDI-DI
- E22110611 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 unfilled resin sealant/coating
Grandio Seal by VOCO GmbH — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental unfilled resin sealant/coating.
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- UltraSeal XT Plus — ULTRADENT PRODUCTS, INC. · Class II
- ResinBlend LV Composite Blending Resin — Den-Mat Holdings, LLC · Class II
- Ribbon — TULSA DENTAL PRODUCTS LLC · Class II
- UltraSeal XT Hydro — ULTRADENT PRODUCTS, INC. · Class II
- Champ — CENTRIX, INC. · Class II
- OptiGuard — KERR CORPORATION · Class II
- OPTIGLAZE™ — Gc America Inc. · Class II
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
- VOCO GmbH
Sources (2)
- FDA UDI 1e87cf4a-f589-4146-bc8b-1ed7cda8db34 37 fields · synced Jun 19, 2026
- EUDAMED 192b93f2-e16d-4aaf-9a85-db8dfd3c3bc5 61 fields · synced Jun 19, 2026