Identity
- Trade Name
- ACL Series EUDAMEDE-CUBE FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- ACL Series EUDAMEDControl Box FDA UDI
- Model / Reference
- E-CUBE EUDAMEDE-CUBE(C/B) FDA UDI
- Description
- Control Box FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260470477 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260470477 EUDAMED
- 510(k) Number
- K111616 FDA UDI
- FDA Product Code
- EKX FDA UDI
- EMDN Code
- L1899 ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER EUDAMED
- GMDN Term
- Dental power tool system, line-powered FDA UDI
Classification
- Device Class
- Class IIa EUDAMEDClass I FDA UDI
- Regulation Number
- 872.4200 FDA UDI
- Market of Registration
- Belgium 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
No
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
No
FDA UDI
Moist Heat or Steam Sterilization FDA UDI
Category: Electrical-only medical device connection cable, reusable
ACL Series by Saeshin Precision Co., Ltd. — Class IIa — FDA_510K, MDD — listed in EUDAMED, FDA GUDID, FDA 510(k) — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
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 | K111616 | Class IIa | Active |
| EUDAMED | European Union | CE/MDD | B-08809260470477 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Saeshin Precision Co., Ltd.
- EUDAMED SRN
- KR-MF-000016345
- Authorised Representative
- Meridius Medical Europe Limited IE-AR-000004258
Sources (3)
- EUDAMED 488aa78d-2085-45a4-bd03-c0491ea47eda 61 fields · synced Aug 3, 2026
- FDA UDI db0cfc0d-be49-4bf0-9aa8-1b866dba5675 34 fields · synced May 30, 2026
- FDA 510(k) K111616 1 fields · synced May 18, 2026