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ACL Series

by Saeshin Precision Co., Ltd. 41 variants

Ref X-CUBE

ACL Series (X-CUBE) is a device classified as Class IIa in the EU and Class I in the US made by Saeshin Precision Co., Ltd., registered in EUDAMED on 12 May 2023 (Basic UDI-DI B-08809260470286), cleared under FDA 510(k) K092758 on 21 Sep 2009 and listed in FDA GUDID since 22 Jan 2020 (UDI-DI 08809260470286), active as of 22 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K092758

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809260470286 Basic UDI-DI 08809260470286UDI-DIDate12 May 2023RegisteredStatusActive
United StatesGUDID listing GUDID Number08809260470286 UDI-DI Date22 Jan 2020ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK092758 Date21 Sep 2009IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-08809260470286 registered 12 May 2023 Active
  • FDA 510(k) K092758 decided 21 Sep 2009 Active
  • FDA GUDID UDI-DI 08809260470286 listed 22 Jan 2020 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K092758
  2. Listed FDA GUDID 08809260470286
  3. Registered EUDAMED B-08809260470286

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
ACL Series EUDAMED
X-Cube GUDID
Generic name
Dental power tool system, line-powered
Model / reference
X-CUBE
Primary DI / UDI-DI
08809260470286
Basic UDI-DI
B-08809260470286
510(k) Number
FDA product code
EBW
EMDN code
L1899 Electrosurgery instruments, reusable - other
GMDN term
Dental power tool system, line-powered
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
System or procedure pack
System which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Belgium
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class I

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Manufacturer details

EUDAMED SRN
KR-MF-000016345
Authorised representative
Meridius Medical Europe Limited IE-AR-000004258

Related devices

Category: Electrical-only medical device connection cable, reusable

Similar devices in this category

Other devices filed under ELECTROSURGERY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Saeshin Precision Co., Ltd.

See all devices from Saeshin Precision Co., Ltd. →

Properties

  • Reusable
  • Serial number
Other properties (21, all answered No)