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Structur 2
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1310Ref 1482Ref 1492Ref 1491Ref 1478Ref 1312Ref 1486Ref 1311Ref 1499
by VOCO GmbH
Identity
- Trade Name
- Structur 2 EUDAMEDFDA UDIStructur 2 SC FDA UDI
- Generic Name
- Temporary dental crown/bridge FDA UDI
- Device Name
- Structur 2 EUDAMED
- Model / Reference
- 1310 EUDAMEDFDA UDI1312 EUDAMEDFDA UDI1499 EUDAMEDFDA UDI1311 EUDAMEDFDA UDI1491 EUDAMEDFDA UDI1478 EUDAMEDFDA UDI1482 EUDAMEDFDA UDI1486 EUDAMEDFDA UDI1492 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 1312 FDA UDI1499 FDA UDI1310 FDA UDI1311 FDA UDI1491 FDA UDI1478 FDA UDI1482 FDA UDI1486 FDA UDI1492 FDA UDI
- Primary DI / UDI-DI
- E22113101 EUDAMEDFDA UDIE22113121 EUDAMEDFDA UDIE22114991 EUDAMEDFDA UDIE22113111 EUDAMEDFDA UDIE22114911 EUDAMEDFDA UDIE22114781 EUDAMEDFDA UDIE22114821 EUDAMEDFDA UDIE22114861 EUDAMEDFDA UDIE22114921 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210425010000000DP EUDAMED++E2210425000000000D4 EUDAMED
- FDA Product Code
- EBG FDA UDI
- EMDN Code
- Q01020605 TEMPORARY DENTAL PROSTHESES EUDAMED
- GMDN Term
- Temporary dental crown/bridge FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3770 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
No
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 UDIFDA 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
Dimensions & Sizes
- Size
- Weight — 75 Gram FDA UDI
Category: Temporary dental crown/bridge
Structur 2 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 | K941124 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210425010000000DP | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (19)
- EUDAMED 0eefa50f-a423-4b9f-ad42-2a7546614a30 61 fields · synced Aug 4, 2026
- FDA UDI 5fabc2fc-d559-4e46-a695-bd9bf3f1b5ca 35 fields · synced May 29, 2026
- FDA UDI 11df6f97-0353-45c0-a02f-cdb7abe54c0e 35 fields · synced May 30, 2026
- FDA UDI 06e6a893-6a80-40e0-b8c4-3816d25ba942 35 fields · synced May 30, 2026
- FDA UDI cccc5ff2-5446-485e-84fd-301298db1586 35 fields · synced May 30, 2026
- FDA UDI 5a144039-8623-4911-be1a-eafb0f430135 35 fields · synced May 30, 2026
- FDA UDI 27b726da-3a54-4cbe-9309-ea89800ee22e 36 fields · synced May 30, 2026
- FDA UDI 53e3264c-49ff-4307-a9fe-026990716418 35 fields · synced May 30, 2026
- FDA UDI e647ffaa-0092-44f1-8b8c-3c04ff72e89f 35 fields · synced May 30, 2026
- FDA UDI 42dbfae6-3398-4f90-8d88-fe758291bbfd 35 fields · synced May 30, 2026
- EUDAMED 4cf74359-ef66-4ebc-af31-23207102562a 61 fields · synced Jul 8, 2026
- EUDAMED f759e6a2-6127-4ff3-9695-57139b910f56 61 fields · synced Jul 8, 2026
- EUDAMED 0173c591-5ed3-4ea0-8cc0-1538d32d25f9 61 fields · synced Jul 13, 2026
- EUDAMED a8a82e79-38bf-4d24-aa15-bab8950eb4c9 61 fields · synced Jul 18, 2026
- EUDAMED bec3fd38-2c2d-4104-b4a7-4dcefbe9c942 61 fields · synced Jul 20, 2026
- EUDAMED 0ccfe166-922a-4225-8eec-1fe6632d1991 61 fields · synced Jul 31, 2026
- EUDAMED 14f1b28c-1687-40e5-b3d4-f828edb3b7d9 61 fields · synced Aug 1, 2026
- EUDAMED 403379bb-653e-4f38-92d2-7451e3aaebd7 61 fields · synced Aug 4, 2026
- FDA 510(k) K941124 1 fields · synced May 18, 2026