Skip to content

Piezon B

by E.M.S. Electro Medical Systems S.A. 2 variants

Ref FT-224

Piezon B (FT-224#C/009) is a device classified as Class IIa in the EU and Class II in the US made by E.M.S. Electro Medical Systems S.A., registered in EUDAMED on 6 Jul 2026 (Basic UDI-DI 07613353030KX), cleared under FDA 510(k) K132445 on 6 Dec 2013 and listed in FDA GUDID since 28 Apr 2022 (UDI-DI 07613353222710), active as of 23 Oct 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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132445

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number07613353030KX Basic UDI-DI Date6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number07613353222710 UDI-DI Date28 Apr 2022ListedStatusListed 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 07613353030KX registered 6 Jul 2026 Active
  • FDA 510(k) K132445 decided 6 Dec 2013 Active
  • FDA GUDID UDI-DI 07613353222710 listed 28 Apr 2022 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K132445
  2. Listed FDA GUDID 07613353222710
  3. Registered EUDAMED 07613353030KX

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  • Withdrawn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
Piezon 250 EUDAMED
Piezon GUDID
Generic name
Ultrasonic dental scaling/debridement system
Model / Ref / Catalog
FT-224 EUDAMED
B GUDID
FT-224#C/009 GUDID
Primary DI / UDI-DI
07613353222710, 07613353257040
Basic UDI-DI
07613353030KX
510(k) Number
FDA product code
ELC
EMDN code
Z12119001 Tartar ablators
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class IIa 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
FT-224
GUDID
B
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa 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: Ultrasonic dental scaling/debridement system

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
  • Serial number
Other properties (23, all answered No)