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Mta
EUDAMEDClass IIa (EU MDR)
Ref 650-07-6Model SILVER MTA 2mmRef 650-02-6Model RESIN MTA SEMI ROUND TYPE
Identity
- Trade Name
- MTA EUDAMED
- Model / Reference
- SILVER MTA 2mm EUDAMED650-07-6 EUDAMEDRESIN MTA SEMI ROUND TYPE EUDAMED650-02-6 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800033437215 EUDAMED08800033437178 EUDAMED
- Basic UDI-DI
- B-08800033437215 EUDAMEDB-08800033437178 EUDAMED
- EMDN Code
- Q010403 ORTHODONTIC BRACKETS AND BUTTONS EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Spain 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
Category: Orthodontic tube
Mta by Osstem Orthodontics Inc. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS
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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-08800033437215 | 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 (2)
- EUDAMED a9f7642f-131e-4444-b381-7d91facd4a5f 61 fields · synced Jul 11, 2026
- EUDAMED c1fd7e9b-1a10-4ca7-bc75-14823fb8f06b 61 fields · synced May 19, 2026