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IonoStar Molar
EUDAMEDFDA UDIFDA 510(k)Class IIa (EU MDR)
Ref 2520Ref 2532Ref 2534Ref 2533Ref 2526Ref 2527
by VOCO GmbH
Identity
- Trade Name
- IonoStar Molar EUDAMEDFDA UDI
- Generic Name
- Glass ionomer dental cement FDA UDI
- Device Name
- IonoStar Molar EUDAMEDGlas ionomer restorative material. FDA UDIGlas ionomer restorative material in three different shades. FDA UDI
- Model / Reference
- 2520 EUDAMEDFDA UDI2526 EUDAMEDFDA UDI2532 EUDAMEDFDA UDI2533 EUDAMEDFDA UDI2534 EUDAMED2527 EUDAMED
- Description
- Glas ionomer restorative material. FDA UDIGlas ionomer restorative material in three different shades. FDA UDI
Identifiers
- Catalog Number
- 2526 FDA UDI2520 FDA UDI2532 FDA UDI2533 FDA UDI
- Primary DI / UDI-DI
- E22125201 EUDAMEDFDA UDIE22125261 EUDAMEDFDA UDIE22125321 EUDAMEDFDA UDIE22125331 EUDAMEDFDA UDIE22125341 EUDAMEDE22125271 EUDAMED
- Basic UDI-DI
- ++E221021100000000067 EUDAMED
- FDA Product Code
- EMA FDA UDI
- EMDN Code
- Q01010106 DENTAL RESTORATION GLASS IONOMERS EUDAMED
- GMDN Term
- Glass ionomer dental cement FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA UDI
- Regulation Number
- 872.3275 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 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
Category: Glass ionomer dental cement
IonoStar Molar 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 | K140993 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E221021100000000067 | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (11)
- EUDAMED 1863a188-b4ae-40ef-9f6b-939c715bf8a7 61 fields · synced Sep 18, 2026
- FDA UDI 4946b4ee-e51e-442b-b7d4-49db8a51e802 36 fields · synced May 30, 2026
- FDA UDI 1d1ba92b-6663-4140-bb00-9373a8480d78 36 fields · synced May 30, 2026
- FDA UDI 62075cf2-cc51-485a-80ab-e846c6a49b96 36 fields · synced May 30, 2026
- FDA UDI cab887ce-b4e5-481a-bf81-3760d5be855c 36 fields · synced May 30, 2026
- EUDAMED 0ecfae01-8bbc-40d6-b5ff-fbd7cedd982d 61 fields · synced Jul 9, 2026
- EUDAMED 58780146-2fde-4898-b41f-68e5523443c6 61 fields · synced Jul 10, 2026
- EUDAMED 601f9587-8c74-42e7-a15d-cb31c635a8f0 61 fields · synced Jul 17, 2026
- EUDAMED cd45753f-a26a-427c-9ebc-d81271b7f1de 61 fields · synced Jul 21, 2026
- EUDAMED d980bca6-a5f8-407d-9706-46923315a45c 61 fields · synced Sep 18, 2026
- FDA 510(k) K140993 1 fields · synced May 18, 2026