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x-tra base
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 1790Ref 1795Ref 1798Ref 1791Ref 1794
by VOCO GmbH
Identity
- Trade Name
- x-tra base EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- x-tra base EUDAMEDFlowable light-curing base composite. 4 mm restorarion base in one simple step. Perfect furface affinity for outstanding adaption. Low shrinkage stress. High radiocapacity (350 %Al). Self-levelling. Can be combined with any methacrylates-based bonding or composite. The non-dripping NDT-syringe or convenient Flow-Caps with bendable metal cannualae ensure a reliable, precisely accurate application. FDA UDI
- Model / Reference
- 1790 EUDAMEDFDA UDI1791 EUDAMEDFDA UDI1798 EUDAMEDFDA UDI1795 EUDAMEDFDA UDI1794 EUDAMEDFDA UDI
- Description
- Flowable light-curing base composite. 4 mm restorarion base in one simple step. Perfect furface affinity for outstanding adaption. Low shrinkage stress. High radiocapacity (350 %Al). Self-levelling. Can be combined with any methacrylates-based bonding or composite. The non-dripping NDT-syringe or convenient Flow-Caps with bendable metal cannualae ensure a reliable, precisely accurate application. FDA UDI
Identifiers
- Catalog Number
- 1791 FDA UDI1798 FDA UDI1795 FDA UDI1790 FDA UDI1794 FDA UDI
- Primary DI / UDI-DI
- E22117901 EUDAMEDFDA UDIE22117911 EUDAMEDFDA UDIE22117981 EUDAMEDFDA UDIE22117951 EUDAMEDFDA UDIE22117941 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210575000000000K4 EUDAMED
- FDA Product Code
- EJK FDA UDIEBF FDA UDI
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
- GMDN Term
- Dental composite resin FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3250 FDA UDI872.3690 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
Category: Dental composite resin
x-tra base 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
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 | K112374 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K123773 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210575000000000K4 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (11)
- EUDAMED 49fb0ab8-f6d9-4302-9b32-672b123ecd0e 61 fields · synced Jul 26, 2026
- FDA UDI 1b40dad6-5b91-4b63-838f-d0747ae7ffcd 36 fields · synced May 30, 2026
- FDA UDI 4165023d-f22a-4852-9e09-735290aaf6ef 36 fields · synced May 30, 2026
- FDA UDI 4c92d116-f805-4672-9fbc-77d4e0e2f530 36 fields · synced May 30, 2026
- FDA UDI 6e4eb09b-3b1a-4ab8-9916-edadf63a0922 36 fields · synced May 30, 2026
- FDA UDI 98919ac0-af71-4671-96c5-1ab52b31da23 36 fields · synced May 30, 2026
- EUDAMED c7e43e4c-b6c9-4114-a1c9-2fd211daeb1b 61 fields · synced Jun 20, 2026
- EUDAMED 6086634a-69b8-48b8-8024-d2008a2a4e22 61 fields · synced Jul 13, 2026
- EUDAMED 9cfb052b-b276-4041-b190-cdd7334a8634 61 fields · synced Jul 24, 2026
- EUDAMED 14360fd3-dc3b-47c5-bbdd-88d9332f6c71 61 fields · synced Jul 26, 2026
- FDA 510(k) K112374 1 fields · synced May 18, 2026