Identity
- Trade Name
- ACL Series EUDAMEDX-CUBE FDA UDI
- Generic Name
- Dental power tool system, line-powered FDA UDI
- Device Name
- ACL Series EUDAMED'1:1, Contra Angle(Lever Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C FDA UDI
- Model / Reference
- X-CUBE EUDAMEDX-CUBE #2 FDA UDI
- Description
- '1:1, Contra Angle(Lever Type #1) X-CUBE(C/B)+X-CUBE(Foot Controller)+Forte 100αEI+ACL-01C FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809260470798 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809260470798 EUDAMED
- 510(k) Number
- K092758 FDA UDI
- FDA Product Code
- EBW 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
ACL Series by Saeshin Precision 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-08809260470798 | Class IIa | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIa | Pending data |
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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 (2)
- EUDAMED 9ea433f9-bc3b-4d7f-a97a-5ff9773f5946 61 fields · synced Jul 19, 2026
- FDA UDI 1922a3d5-19ef-4a9e-9184-07d022a3043d 34 fields · synced May 30, 2026