Identity
- Trade Name
- MDK HANDPIECES EUDAMEDAir-Driven Dental Handpieces FDA UDI
- Generic Name
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
- Device Name
- ELECTRICAL AIR DRIVEN DENTAL HAND PIECE EUDAMED
- Model / Reference
- MOKO 760K LED EUDAMEDFDA UDI
Identifiers
- Primary DI / UDI-DI
- 08800027300013 EUDAMED00880027300013 FDA UDI
- Basic UDI-DI
- B-08800027300013 EUDAMED
- 510(k) Number
- K141886 FDA UDI
- FDA Product Code
- EFB FDA UDI
- EMDN Code
- L030199 GENERAL SURGERY SURGICAL CANNULAS AND HANDPIECES, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental surgical power tool motorized handpiece/set, pneumatic FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Germany EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Mdk Handpieces by Mdk Co., Ltd. — Class IIa — MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08800027300013 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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Manufacturer
- Manufacturer
- Mdk Co., Ltd.
- EUDAMED SRN
- KR-MF-000042246
- Authorised Representative
- KTR Europe GmbH DE-AR-000005685
Sources (2)
- EUDAMED 8bfa4d06-9ba3-4377-a48d-0115e12b0ac0 61 fields · synced May 31, 2026
- FDA UDI cbd97a14-ab0d-479c-b3f5-b7d95e106c7a 33 fields · synced May 29, 2026