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Boost wireless pedal EK-404B

by E.M.S. Electro Medical Systems S.A.

Part of a family of 7 devices: see the family page

Ref EK-404B/D

Boost wireless pedal EK-404B (EK-404B/D) is a device classified as Class I in the EU and Class II in the US made by E.M.S. Electro Medical Systems S.A., registered in EUDAMED on 6 Nov 2026 (Basic UDI-DI 07613353042L6), cleared under FDA 510(k) K190124 on 20 Oct 2019 and listed in FDA GUDID since 14 Jul 2026 (UDI-DI 07613353311896), active as of 7 Nov 2026.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

3 ongoing

Recall on shared 510(k) K190124; other models may be affected

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K190124

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613353042L6 Basic UDI-DI 07613353311896UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613353311896 UDI-DI Date14 Jul 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK190124 Date20 Oct 2019DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07613353042L6 registered 6 Nov 2026 Active
  • FDA 510(k) K190124 decided 20 Oct 2019 Active
  • FDA GUDID UDI-DI 07613353311896 listed 14 Jul 2026 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1686-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124
    • Ongoing Z-1687-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124
    • Ongoing Z-1688-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

6 dated events

  1. Cleared FDA 510(k) K190124
  2. Recall initiated FDA recalls Z-1686-2024
  3. Recall initiated FDA recalls Z-1687-2024
  4. Recall initiated FDA recalls Z-1688-2024
  5. Listed FDA GUDID 07613353311896
  6. Registered EUDAMED 07613353042L6

Coverage

2 jurisdictions

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

Specification

EUDAMED · GUDID

Trade name
Boost wireless pedal
Generic name
Foot-switch, electrical
Device name
Dental Pedals
Model / Ref / Catalog
EK-404B/D, EK-404B
Primary DI / UDI-DI
07613353311896
Basic UDI-DI
07613353042L6
510(k) Number
FDA product code
KOJ
EMDN code
Z12119001 Tartar ablators
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.6080
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
EK-404B/D
GUDID
EK-404B
Device classEUDAMED
Class I
GUDID
Class II

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

Related devices

Cleared under the same submission (K190124)

and 8 more cleared under K190124

Similar devices in this category

Other devices filed under TARTAR ABLATORS.

Other devices from Electro Medical Systems (Ems Sa)

See all devices from Electro Medical Systems (Ems Sa) →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)