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MTA Wire
EUDAMEDClass IIa (EU MDR)
Ref 753-01Model MTA WIRE 45℃ 0.012"Ref 751-01Model MTA WIRE 35℃ 0.012"Ref 750-01Model MTA WIRE 0.012" NiTi StandardRef 750-03Model MTA WIRE 0.012" NiTi Less roundRef 750-02Model MTA WIRE 0.014" NiTi Standard
Identity
- Trade Name
- MTA Wire EUDAMED
- Model / Reference
- MTA WIRE 45℃ 0.012" EUDAMED753-01 EUDAMEDMTA WIRE 35℃ 0.012" EUDAMED751-01 EUDAMEDMTA WIRE 0.012" NiTi Standard EUDAMED750-01 EUDAMEDMTA WIRE 0.012" NiTi Less round EUDAMED750-03 EUDAMEDMTA WIRE 0.014" NiTi Standard EUDAMED750-02 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033437413 EUDAMED08800033469209 EUDAMED08800033437369 EUDAMED08800033437383 EUDAMED08800033437376 EUDAMED
- Basic UDI-DI
- B-08800033437413 EUDAMEDB-08800033469209 EUDAMEDB-08800033437369 EUDAMEDB-08800033437383 EUDAMEDB-08800033437376 EUDAMED
- EMDN Code
- Q010405 ORTHODONTIC WIRES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Italy EUDAMEDSpain EUDAMEDTürkiye EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
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
MTA Wire by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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-08800033437413 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Osstem Orthodontics Inc.
- EUDAMED SRN
- KR-MF-000021559
- Authorised Representative
- AR Experts B.V. NL-AR-000023989
Sources (5)
- EUDAMED 952f69ec-6223-4fac-9305-c7463a136971 61 fields · synced Jul 25, 2026
- EUDAMED 353e6253-ec4b-44a5-bbcf-4d17a9f08fd4 61 fields · synced May 17, 2026
- EUDAMED d9e1f54d-1839-4a8d-b889-2ff1c0f0c290 61 fields · synced May 17, 2026
- EUDAMED 22bef9d6-891c-446f-9117-ced3681ca43d 61 fields · synced May 18, 2026
- EUDAMED c06c04ba-8d53-4c65-b719-5d95d126bcf7 61 fields · synced May 18, 2026