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Dental polishing grinding head
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref OW-01-WModel OW-01-W OW-02-W OW-20-1 OW-20-2 OW-20-3 OW-20-4 OW-20-5 OW-20-6 OW-HP-3-A OW-HP-3-B OW-HP-3-C OW-HP-3-D OW-HP-3-E OW-HP-3-F OW-SR-1-A OW-SR-1- B OW-SR-1-C OW-SR-1-D OW-SR-1-E OW-SR-1-F etc510(k) K051719
Identity
- Device Name
- Dental polishing grinding head EUDAMED
- Model / Reference
- OW-01-W OW-02-W OW-20-1 OW-20-2 OW-20-3 OW-20-4 OW-20-5 OW-20-6 OW-HP-3-A OW-HP-3-B OW-HP-3-C OW-HP-3-D OW-HP-3-E OW-HP-3-F OW-SR-1-A OW-SR-1- B OW-SR-1-C OW-SR-1-D OW-SR-1-E OW-SR-1-F etc EUDAMEDOW-01-W EUDAMED
Identifiers
- Primary DI / UDI-DI
- 06975702481065 EUDAMED
- Basic UDI-DI
- 697570248DPGH01M7 EUDAMED
- EMDN Code
- Q01010403 DENTAL ABRASIVE AND POLISHING MATERIALS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
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
Dental polishing grinding head by Dongguan Ouwen Medical Device Technology Co., Ltd — Class I — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K051719 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 697570248DPGH01M7 | Class I | Active |
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Manufacturer
- Manufacturer
- Dongguan Ouwen Medical Device Technology Co., Ltd
- EUDAMED SRN
- CN-MF-000013171
- FDA Applicant
- A.B. Dental Devices , Ltd.
- Authorised Representative
- SUNGO Europe B.V. NL-AR-000000247
Sources (2)
- EUDAMED 182062fb-338b-482b-8844-4b5d50db1131 85 fields · synced Jun 18, 2026
- FDA 510(k) K051719 1 fields · synced May 18, 2026