Identity
- Trade Name
- Twinky Star FDA UDI
- Generic Name
- Dental composite resin FDA UDI
- Device Name
- Twinky Star EUDAMEDColoured light-curing compmer restorative material with glitter effect. This kit contains 40 caps (5 of each shade) and a shade guide. FDA UDI
- Model / Reference
- 1680 EUDAMEDFDA UDI
- Description
- Coloured light-curing compmer restorative material with glitter effect. This kit contains 40 caps (5 of each shade) and a shade guide. FDA UDI
Identifiers
- Catalog Number
- 1680 FDA UDI
- Primary DI / UDI-DI
- E22116801 EUDAMEDFDA UDI
- Basic UDI-DI
- ++E2210465000000000GY EUDAMED
- 510(k) Number
- K022797 FDA UDI
- FDA Product Code
- EBF FDA UDI
- EMDN Code
- Q01010105 DENTAL RESTORATION COMPOMERS 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
Yes
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
Twinky Star 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
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K022797 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | ++E2210465000000000GY | Class IIa | Active |
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Manufacturer
- Manufacturer
- VOCO GmbH
- EUDAMED SRN
- DE-MF-000008601
Sources (3)
- EUDAMED 3ed9a144-0a0a-4316-aa55-46d2c15d782e 61 fields · synced Jul 15, 2026
- FDA UDI 97fe58a0-003a-44e2-ac08-3349bc4489b0 37 fields · synced May 30, 2026
- FDA 510(k) K022797 1 fields · synced May 18, 2026