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IH Cement Abutment
EUDAMEDFDA 510(k)Class IIb (EU MDR)
Ref AIHCARN5525MCModel IH IMPLANT SYSTEM 510(k) K153521
Identity
- Trade Name
- IH Cement Abutment EUDAMED
- Device Name
- IH Cement Abutment EUDAMED
- Model / Reference
- IH IMPLANT SYSTEM EUDAMEDAIHCARN5525MC EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800041323579 EUDAMED
- Basic UDI-DI
- B-08800041323579 EUDAMED
- EMDN Code
- P01020101 DENTAL IMPLANTS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Poland 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
IH Cement Abutment by SEWONMEDIX Inc. — Class IIb — FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
United States Active
FDA_510K
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K222707 | Class IIb | Active |
| FDA 510(k) | United States | FDA_510K | K153521 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08800041323579 | Class IIb | Active |
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Manufacturer
- Manufacturer
- SEWONMEDIX Inc.
- EUDAMED SRN
- KR-MF-000016194
- FDA Applicant
- Sewonmedix, Inc.
- Authorised Representative
- Advena Limited MT-AR-000000234
Sources (2)
- EUDAMED 7039aa9a-196c-4df4-bb02-fd064822e9e9 85 fields · synced Jun 18, 2026
- FDA 510(k) K222707 1 fields · synced May 18, 2026