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Grandio blocs
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 6003Ref 6157Ref 6023Ref 6174Ref 6015Ref 6156Ref 6024Ref 6179Ref 6172Ref 6007Ref 6163Ref 6012Ref 6159Ref 6021Ref 6165Ref 6164Ref 6018Ref 6005Ref 6013Ref 6020Ref 6029Ref 6014Ref 6022Ref 6169Ref 6170Ref 6037Ref 6177Ref 6019Ref 6154
by VOCO GmbH
Identity
- Trade Name
- Grandio blocs EUDAMEDFDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Grandio blocs EUDAMED5x Gr. 14L A3 HT (HighTranslucent) FDA UDIA3 HT (High translucent) FDA UDIBL LT (Low translucent) FDA UDI5x Gr. 14L A1 HT (HighTranslucent) FDA UDIA3.5 HT (High translucent) FDA UDI5x Gr. 12 B1 LT (Low Translucent) FDA UDI5x Gr. 12 A3.5 LT (Low Translucent) FDA UDIA3 LT (Low Translucent) FDA UDI5x Gr. 14L BL LT (Low Translucent) FDA UDIA1 LT (Low translucent) FDA UDIB1 LT (Low translucent) FDA UDI5x Gr. 12 A3.5 HT (High Translucent) FDA UDIC2 LT (Low translucent) FDA UDI5x Gr. 12 BL LT (Low Translucent) FDA UDIA2 LT (Low translucent) FDA UDI5x Gr. 14L B1 LT (Low Translucent) FDA UDI5x Gr. 12 A2 LT (Low Translucent) FDA UDIA2 HT (High translucent) FDA UDI5x Gr. 12 A3 HT (High Translucent) FDA UDI5x Gr. 14L A2 LT (Low Translucent) FDA UDI5x Gr. 14L A3 LT (Low Translucent) FDA UDI5x Gr. 12 A2 HT (High Translucent) FDA UDIA1 HT (High translucent) FDA UDIA3.5 LT (Low translucent) FDA UDI
- Model / Reference
- 6003 EUDAMEDFDA UDI6179 EUDAMEDFDA UDI6029 EUDAMEDFDA UDI6024 EUDAMEDFDA UDI6177 EUDAMEDFDA UDI6015 EUDAMEDFDA UDI6157 EUDAMEDFDA UDI6156 EUDAMEDFDA UDI6005 EUDAMEDFDA UDI6174 EUDAMEDFDA UDI6018 EUDAMEDFDA UDI6022 EUDAMEDFDA UDI6165 EUDAMEDFDA UDI6023 EUDAMEDFDA UDI6159 EUDAMEDFDA UDI6019 EUDAMEDFDA UDI6172 EUDAMEDFDA UDI6154 EUDAMEDFDA UDI6013 EUDAMEDFDA UDI6164 EUDAMEDFDA UDI6169 EUDAMEDFDA UDI6170 EUDAMEDFDA UDI6163 EUDAMEDFDA UDI6014 EUDAMEDFDA UDI6012 EUDAMEDFDA UDI6020 EUDAMEDFDA UDI6021 EUDAMEDFDA UDI6007 EUDAMEDFDA UDI6037 EUDAMED
- Description
- 5x Gr. 14L A3 HT (HighTranslucent) FDA UDIA3 HT (High translucent) FDA UDIBL LT (Low translucent) FDA UDI5x Gr. 14L A1 HT (HighTranslucent) FDA UDIA3.5 HT (High translucent) FDA UDI5x Gr. 12 B1 LT (Low Translucent) FDA UDI5x Gr. 12 A3.5 LT (Low Translucent) FDA UDIA3 LT (Low Translucent) FDA UDI5x Gr. 14L BL LT (Low Translucent) FDA UDIA1 LT (Low translucent) FDA UDIB1 LT (Low translucent) FDA UDI5x Gr. 12 A3.5 HT (High Translucent) FDA UDIC2 LT (Low translucent) FDA UDI5x Gr. 12 BL LT (Low Translucent) FDA UDIA2 LT (Low translucent) FDA UDI5x Gr. 14L B1 LT (Low Translucent) FDA UDI5x Gr. 12 A2 LT (Low Translucent) FDA UDIA2 HT (High translucent) FDA UDI5x Gr. 12 A3 HT (High Translucent) FDA UDI5x Gr. 14L A2 LT (Low Translucent) FDA UDI5x Gr. 14L A3 LT (Low Translucent) FDA UDI5x Gr. 12 A2 HT (High Translucent) FDA UDIA1 HT (High translucent) FDA UDIA3.5 LT (Low translucent) FDA UDI
Identifiers
- Catalog Number
- 6179 FDA UDI6029 FDA UDI6024 FDA UDI6177 FDA UDI6015 FDA UDI6157 FDA UDI6156 FDA UDI6005 FDA UDI6174 FDA UDI6018 FDA UDI6022 FDA UDI6165 FDA UDI6023 FDA UDI6159 FDA UDI6019 FDA UDI6003 FDA UDI6172 FDA UDI6154 FDA UDI6013 FDA UDI6164 FDA UDI6169 FDA UDI6170 FDA UDI6163 FDA UDI6014 FDA UDI6012 FDA UDI6020 FDA UDI6021 FDA UDI6007 FDA UDI
- Primary DI / UDI-DI
- E22160031 EUDAMEDFDA UDIE22161791 EUDAMEDFDA UDIE22160291 EUDAMEDFDA UDIE22160241 EUDAMEDFDA UDIE22161771 EUDAMEDFDA UDIE22160151 EUDAMEDFDA UDIE22161571 EUDAMEDFDA UDIE22161561 EUDAMEDFDA UDIE22160051 EUDAMEDFDA UDIE22161741 EUDAMEDFDA UDIE22160181 EUDAMEDFDA UDIE22160221 EUDAMEDFDA UDIE22161651 EUDAMEDFDA UDIE22160231 EUDAMEDFDA UDIE22161591 EUDAMEDFDA UDIE22160191 EUDAMEDFDA UDIE22161721 EUDAMEDFDA UDIE22160131 EUDAMEDFDA UDIE22161641 EUDAMEDFDA UDIE22161691 EUDAMEDFDA UDIE22161701 EUDAMEDFDA UDIE22161631 EUDAMEDFDA UDIE22160141 EUDAMEDFDA UDIE22160121 EUDAMEDFDA UDIE22160201 EUDAMEDFDA UDIE22160211 EUDAMEDFDA UDIE22160071 EUDAMEDFDA UDIE22160371 EUDAMEDE22161541 EUDAMEDE2216154 FDA UDI
- Basic UDI-DI
- ++E2210169000000000H5 EUDAMED++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 IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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 | K051867 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K030915 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K171200 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210169000000000H5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (58)
- EUDAMED f19eef12-2005-4e42-aa7a-415d09597f47 61 fields · synced Sep 18, 2026
- FDA UDI 3837d35c-e853-446c-9bdf-0ac96684dbb7 36 fields · synced May 27, 2026
- FDA UDI e9ba6ac2-32a4-4ca8-bfcb-9e27d9a0b4c7 36 fields · synced May 27, 2026
- FDA UDI edd90fac-bb12-4cf1-b111-8959a9e1f12e 36 fields · synced May 27, 2026
- FDA UDI b36ce2c5-e54b-43ae-ab5d-61309526e704 36 fields · synced May 29, 2026
- FDA UDI 70032b4f-b0ee-4340-a7d6-a0fc7b93e040 36 fields · synced May 29, 2026
- FDA UDI 2eeb0d17-3184-4ef0-8ef1-9720f50b2415 36 fields · synced May 29, 2026
- FDA UDI a242e746-6dc4-4ebf-bc4f-6f6759c4b1be 36 fields · synced May 30, 2026
- FDA UDI 7987512e-9ec1-4096-aa9a-e1b9f1e09bc4 36 fields · synced May 30, 2026
- FDA UDI fe1acef4-2391-4acc-bad8-72560cf6deb1 36 fields · synced May 30, 2026
- FDA UDI d0b3d287-ac5c-4f70-ae5e-fe936e8471c8 36 fields · synced May 30, 2026
- FDA UDI d0c7b11c-c632-46c2-96b2-bbee1ded4532 36 fields · synced May 30, 2026
- FDA UDI f364438f-2d68-4d9f-9cf7-614b1686a2ca 36 fields · synced May 30, 2026
- FDA UDI bb0a8d98-1ad6-464a-a930-f739513ab3cf 36 fields · synced May 30, 2026
- FDA UDI 136eb047-5b68-4b60-a0ec-667fa108b610 36 fields · synced May 30, 2026
- FDA UDI c7abe3c8-0128-4b25-86e3-c8d08d698c70 36 fields · synced May 30, 2026
- FDA UDI dd73572d-bf7f-4f71-b768-8bc5124a55b0 36 fields · synced May 30, 2026
- FDA UDI ce65e9f4-63e7-4a02-9e1c-7e09f70254dd 36 fields · synced May 30, 2026
- FDA UDI 4daaa89b-4bc7-4288-a781-b110d49e55b4 36 fields · synced May 30, 2026
- FDA UDI 38412e25-fbbd-4f12-99be-ffaf5672751a 36 fields · synced May 30, 2026
- FDA UDI 4a624f3b-fd3a-4263-998c-8e47bd9c6871 36 fields · synced May 30, 2026
- FDA UDI beca106e-781c-4dd6-beec-e167a2e80df0 36 fields · synced May 30, 2026
- FDA UDI 899ba962-2074-4a20-a76d-aa50edfbf3c0 36 fields · synced May 30, 2026
- FDA UDI c2f4a03a-ca00-4681-9f90-0c9c2d892f51 36 fields · synced May 30, 2026
- FDA UDI 682250fc-9c58-491c-b8d2-872173435b7c 36 fields · synced May 30, 2026
- FDA UDI adf924a2-fc32-4881-b1d8-3f1db04aa6c7 36 fields · synced May 30, 2026
- FDA UDI 02c54642-a38e-477b-823f-5d7637d5c4e6 36 fields · synced May 30, 2026
- FDA UDI 0dfe6330-e571-4e16-b17d-268e434d2226 36 fields · synced May 30, 2026
- FDA UDI 90dc0cfc-cf2e-4c9d-8c75-5a560ddd5164 36 fields · synced May 30, 2026
- EUDAMED 62f99796-da04-4480-a325-f30ed655f4de 61 fields · synced Jun 20, 2026
- EUDAMED 3f91e05f-6ae5-4cdc-a791-3fff777f1298 61 fields · synced Jul 9, 2026
- EUDAMED 8614b9d2-7765-4ffe-9d6e-07f8657e3756 61 fields · synced Jul 9, 2026
- EUDAMED ab70e06b-ba85-42e4-8c92-1803972e74bc 61 fields · synced Jul 10, 2026
- EUDAMED 927946cb-673b-44b4-99bd-becdea77ca2f 61 fields · synced Jul 11, 2026
- EUDAMED a73ae84a-e3cb-4c1e-9fa0-6735ac65cdcf 61 fields · synced Jul 12, 2026
- EUDAMED 82efb820-c0dc-4834-9506-34b838c06725 61 fields · synced Jul 14, 2026
- EUDAMED de0fddbb-284c-4f40-9733-1b57fd5979e2 61 fields · synced Jul 14, 2026
- EUDAMED 37afd433-14cb-433f-816c-93a3dbd1cbfd 61 fields · synced Jul 14, 2026
- EUDAMED 7d492fda-2dca-4ebc-a1b6-061dca13a134 61 fields · synced Jul 15, 2026
- EUDAMED 7da9babc-c38a-4486-a863-5790e381b211 61 fields · synced Jul 15, 2026
- EUDAMED e3fa34d9-11ef-46d0-97f3-2e2b580c2316 61 fields · synced Jul 15, 2026
- EUDAMED 35e02183-16e5-4078-8912-e3df2637aed5 61 fields · synced Jul 15, 2026
- EUDAMED 5a0d9d40-e003-46d5-957b-44b25c6ab055 61 fields · synced Jul 17, 2026
- EUDAMED 6404b224-72fa-48a5-912f-fc3af1220ead 61 fields · synced Jul 17, 2026
- EUDAMED 9fa1be61-e455-46d6-a377-6bd88a307a7f 61 fields · synced Jul 18, 2026
- EUDAMED 944e7b81-27fb-468e-915e-d39ff327d988 61 fields · synced Jul 20, 2026
- EUDAMED c9237e46-f316-4738-8c25-41099c6a9fd6 61 fields · synced Jul 22, 2026
- EUDAMED 29d92f7c-8218-4fb7-ac45-e0a06eaf2536 61 fields · synced Jul 24, 2026
- EUDAMED 1e16b8d2-ed08-49cf-b830-95d686440c02 61 fields · synced Jul 26, 2026
- EUDAMED bdcf205c-e71c-458f-b347-9f07d2e9b46f 61 fields · synced Jul 26, 2026
- EUDAMED cd405c6b-600e-4b8d-a6c6-34f65faac65e 61 fields · synced Jul 27, 2026
- EUDAMED e45fca89-2924-429d-8e1b-aa5f80f43dcb 61 fields · synced Jul 28, 2026
- EUDAMED 5f3b3c14-8a85-4080-9954-b9fbb0a316c7 61 fields · synced Jul 30, 2026
- EUDAMED 3e599179-e556-44ee-9721-15c13e3e1238 61 fields · synced Jul 31, 2026
- EUDAMED 06c26cdf-acaa-4047-bfd3-6714965ef646 61 fields · synced Jul 31, 2026
- EUDAMED 5b8c923b-327b-40f6-b17f-ce7070cfd25c 61 fields · synced Aug 4, 2026
- EUDAMED a66dbf7a-fad0-4d46-a9d2-560a4baaff70 61 fields · synced Sep 18, 2026
- FDA 510(k) K051867 1 fields · synced May 18, 2026