← Back to catalogue
T Core
EUDAMEDClass IIa (EU MDR)
Ref FP1004A3Model T Core A3Ref FP1004TLModel T Core TLRef FP1004BLModel T Core BlueRef FP1004WTModel T Core WT
Identity
- Device Name
- T Core EUDAMED
- Model / Reference
- T Core A3 EUDAMEDFP1004A3 EUDAMEDT Core TL EUDAMEDFP1004TL EUDAMEDT Core Blue EUDAMEDFP1004BL EUDAMEDT Core WT EUDAMEDFP1004WT EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800032401651 EUDAMED08800032401668 EUDAMED08800032401675 EUDAMED08800032401682 EUDAMED
- Basic UDI-DI
- B-08800032401651 EUDAMEDB-08800032401668 EUDAMEDB-08800032401675 EUDAMEDB-08800032401682 EUDAMED
- EMDN Code
- Q01010103 DENTAL RESTORATIVE COMPOSITES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Türkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
Yes
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Dental composite resin
T Core by Nexobio Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Dental composite resin.
- Name: Light Curing Composite Model: Flow — Micerium S.p.A. · Class IIa
- Forma S — ULTRADENT PRODUCTS, INC. · Class II
- NovaPro Fill — NANOVA BIOMATERIALS INC · Class II
- SimpliShade — KERR CORPORATION · Class II
- Bright Flow Core DC 5ml Dentine — DMP Dental Industry S.A. · Class IIa
- Llis — Dentscare Ltda · Class II
- Capo Universal, 6 g — Schütz Dental GmbH · Class II
- OMNICHROMA — TOKUYAMA DENTAL CORPORATION · Class II
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800032401651 | Class IIa | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Nexobio Co., Ltd.
- EUDAMED SRN
- KR-MF-000043543
- Authorised Representative
- Mega Diş Deposu /Mustafa Soydan-Mete Yılmaz TR-AR-000040213
Sources (4)
- EUDAMED 4855d818-da25-4041-8858-baeddf6c2a7e 61 fields · synced Jul 30, 2026
- EUDAMED afdac82b-4e19-4472-b48b-c074b7716e2b 61 fields · synced May 16, 2026
- EUDAMED b8e3ac91-0e34-4e94-8fe8-aa24992f39cd 61 fields · synced May 18, 2026
- EUDAMED aea97eb0-15d4-4bf2-8ba2-b09d95c8c42d 61 fields · synced May 19, 2026