Identity
- Trade Name
- OK-Handpiece EUDAMED
- Device Name
- Low Speed Dental Handpiece, pneumatic EUDAMEDOK-Handpiece EUDAMED
- Model / Reference
- OKH4 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08800115200010 EUDAMED
- Basic UDI-DI
- 88001152H-0001PL EUDAMEDB-08800115200010 EUDAMED
- EMDN Code
- Z12110199 INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Poland EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMED
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
OK-Handpiece by Jaintek Co., Ltd. — Class IIa — FDA_510K, MDD, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDD
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K221814 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | 88001152H-0001PL | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 88001152H-0001PL | Class IIa | Active |
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Manufacturer
- Manufacturer
- Jaintek Co., Ltd.
- EUDAMED SRN
- KR-MF-000045113
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (3)
- EUDAMED bc33a06a-0037-4302-8717-531edd3c828c 61 fields · synced Jul 8, 2026
- EUDAMED 8f5222a3-c6b1-43a5-abae-c2cc8bd0f517 61 fields · synced May 18, 2026
- FDA 510(k) K221814 1 fields · synced May 18, 2026