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Mectron Ps Medical + Handpiece

by Mectron SpA

Mectron Ps Medical + Handpiece (03120219-001) is a Class I device made by Mectron SpA, cleared under FDA 510(k) K153743 on 25 May 2016 and listed in FDA GUDID since 23 Sep 2016 (UDI-DI E322031202190010), active as of 23 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 23 Oct 2026

Documents

510(k) K153743

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberE322031202190010 UDI-DI Date23 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) from GUDID NumberK153743 Date25 May 2016IssuedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K153743 decided 25 May 2016 Active
  • FDA GUDID UDI-DI E322031202190010 listed 23 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K153743
  2. Listed FDA GUDID E322031202190010

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Mectron
Generic name
Dental ultrasonic surgical system handpiece
Model / Ref / Catalog
PS MEDICAL + HANDPIECE, 03120219-001
Primary DI / UDI-DI
E322031202190010
510(k) Number
FDA product code
HWE, HBE, ERL, DZI, JDX
GMDN term
Dental ultrasonic surgical system handpiece
Device class
Class I
Regulation number
878.4820, 882.4310, 874.4250, 872.4120, 888.4580
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental ultrasonic surgical system handpiece

Cleared under the same submission (K153743)

and 8 more cleared under K153743

Similar devices

Other devices filed under FDA product code HWE (Instrument, Surgical, Orthopedic, Ac-Powered Motor And Accessory/Attachment).

Other devices from Mectron SpA

  • Mectron OP1125

    Class II

  • Mectron OP1225

    Class II

  • Mectron EX0410

    Class II

  • Mectron EX0510

    Class II

See all devices from Mectron SpA →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (11, all answered No)