Identity
- Trade Name
- Grandio blocs EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Grandio blocs EUDAMED5x Gr. 12 A3 HT (High Translucent) FDA UDI
- Model / Reference
- 6164 EUDAMEDFDA UDI
- Description
- 5x Gr. 12 A3 HT (High Translucent) FDA UDI
Identifiers
- Catalog Number
- 6164 FDA UDI
- Primary DI / UDI-DI
- E22161641 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210174000000000DK EUDAMED
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q010699 MATERIALS FOR THE PREPARATION OF CUSTOM-MADE DENTAL DEVICES - OTHER EUDAMED
- GMDN Term
- Temporary dental crown/bridge 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 blocs by VOCO GmbH — Class II — FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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 |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- VOCO GmbH
Sources (2)
- FDA UDI 4a624f3b-fd3a-4263-998c-8e47bd9c6871 36 fields · synced Oct 8, 2026
- EUDAMED 6404b224-72fa-48a5-912f-fc3af1220ead 61 fields · synced Jul 17, 2026