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PIEZON c

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

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

Ref EK-128

PIEZON c (EK-128) 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) K132445 on 6 Dec 2013 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07613353002350), 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

None found

in data synced 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132445

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 07613353002350UDI-DIDate6 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613353002350 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK132445 Date6 Dec 2013DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 07613353042L6 registered 6 Nov 2026 Active
  • FDA 510(k) K132445 decided 6 Dec 2013 Active
  • FDA GUDID UDI-DI 07613353002350 listed 1 Sep 2016 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132445
  2. Listed FDA GUDID 07613353002350
  3. 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  • Withdrawn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
Foot pedal EUDAMED
Piezon GUDID
Generic name
Foot-switch, electrical
Device name
Dental Pedals
Model / Ref / Catalog
EK-128, c
Primary DI / UDI-DI
07613353002350
Basic UDI-DI
07613353042L6
510(k) Number
FDA product code
ELC
EMDN code
Z12119001 Tartar ablators
GMDN term
Foot-switch, electrical
Device class
Class I EUDAMED
Class II GUDID
Regulation number
872.4850
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-128
GUDID
c
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

Category: Foot-switch, electrical

Cleared under the same submission (K132445)

and 8 more cleared under K132445

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
  • Lot / batch number
Other properties (23, all answered No)