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Piezon

by E.M.S. Electro Medical Systems S.A. 14 variants

Piezon (FT-224#HF/A/002) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K132445 on 6 Dec 2013 and listed in FDA GUDID since 14 Dec 2018 (UDI-DI 07613353172442), active as of 21 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 21 Oct 2026

Documents

510(k) K132445

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353172442 UDI-DI Date14 Dec 2018ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Special NumberK132445 Date6 Dec 2013DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132445 decided 6 Dec 2013 Active
  • FDA GUDID UDI-DI 07613353172442 listed 14 Dec 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132445
  2. Listed FDA GUDID 07613353172442

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Ultrasonic dental scaling/debridement system
Model / Ref / Catalog
E, FT-224#HF/A/002
Primary DI / UDI-DI
07613353172442
510(k) Number
FDA product code
ELC
GMDN term
Ultrasonic dental scaling/debridement system
Device class
Class II
Regulation number
872.4850
GUDID distribution status
In Commercial Distribution

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Other devices from Electro Medical Systems (Ems Sa)

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Properties

  • Prescription use
  • Serial number
Other properties (13, all answered No)