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Admira Fusion 5
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 6225510(k) K150784Ref 6237Ref 6238Ref 6243Ref 6244Ref 6235Ref 6229
by VOCO GmbH
Identity
- Trade Name
- Admira Fusion 5 EUDAMEDFDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Admira Fusion 5 EUDAMEDAdmira Fusion 5 is a light-curing, radiopaque nano-hybrid ORMOCER® restorative material. Admira Fusion 5 contains 83% by weight inorganic fillers and is applied with a dentin enamel bond. It is available in screw syringes and caps for direct application. The simplified shade system of Admira Fusion 5 with its five Cluster-Shades covers all 16 VITA® classical shades. FDA UDI
- Model / Reference
- 6225 EUDAMEDFDA UDI6238 EUDAMEDFDA UDI6235 EUDAMEDFDA UDI6229 EUDAMEDFDA UDI6243 EUDAMEDFDA UDI6237 EUDAMEDFDA UDI6244 EUDAMED
- Description
- Admira Fusion 5 is a light-curing, radiopaque nano-hybrid ORMOCER® restorative material. Admira Fusion 5 contains 83% by weight inorganic fillers and is applied with a dentin enamel bond. It is available in screw syringes and caps for direct application. The simplified shade system of Admira Fusion 5 with its five Cluster-Shades covers all 16 VITA® classical shades. FDA UDI
Identifiers
- Catalog Number
- 6238 FDA UDI6225 FDA UDI6235 FDA UDI6229 FDA UDI6243 FDA UDI6237 FDA UDI
- Primary DI / UDI-DI
- E22162251 EUDAMEDFDA UDIE22162381 EUDAMEDFDA UDIE22162351 EUDAMEDFDA UDIE22162291 EUDAMEDFDA UDIE22162431 EUDAMEDFDA UDIE22162371 EUDAMEDFDA UDIE22162441 EUDAMED
- Basic UDI-DI
- ++E2210089000000000HW EUDAMED
- 510(k) Number
- K230877 FDA UDI
- FDA Product Code
- EBF 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
- 872.3690 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
Admira Fusion 5 by VOCO GmbH — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Also classified as Dental composite resin.
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- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
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 | K230877 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K150784 | Class IIa | Active |
| FDA 510(k) | United States | FDA_510K | K994056 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210089000000000HW | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (14)
- EUDAMED 671d835e-9456-411b-b98b-50c5c73ef713 85 fields · synced Jul 30, 2026
- FDA UDI 0434826c-daa1-41a9-be41-79669147d2dc 37 fields · synced May 29, 2026
- FDA UDI 44af2ed5-cc9f-4210-b8e3-87caedbefa53 37 fields · synced May 30, 2026
- FDA UDI 68a35f91-d00d-44ff-a2c9-fd34c96dafd5 37 fields · synced May 30, 2026
- FDA UDI 66e58098-2d57-4726-873d-0bc756a36653 37 fields · synced May 30, 2026
- FDA UDI 4cd061aa-3e38-42f0-aac4-ed93bc0f0525 37 fields · synced May 30, 2026
- FDA UDI 6515dd2e-6fa5-4c98-a913-7a3d4b034d98 37 fields · synced May 30, 2026
- EUDAMED f4c2e248-2123-472e-96f7-f3369b6aa17c 61 fields · synced Jul 8, 2026
- EUDAMED 754c43b6-91e2-4a58-89cc-a066fa1bf681 61 fields · synced Jul 9, 2026
- EUDAMED 5f1fb86c-11d7-46e5-a515-155e34ce1483 61 fields · synced Jul 15, 2026
- EUDAMED 02cca9e4-3c05-442f-b766-a71e5d1ad734 61 fields · synced Jul 15, 2026
- EUDAMED 6f79ead6-3064-4b11-8efb-265e55fcce7e 61 fields · synced Jul 26, 2026
- EUDAMED 2c7d55ea-8579-4189-8631-9ebce6dfaad1 61 fields · synced Jul 30, 2026
- FDA 510(k) K230877 1 fields · synced May 18, 2026