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Piezon Master Surgery

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

Piezon Master Surgery (DS-101) is a Class II device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K072146 on 18 Dec 2007 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07613353002640), 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) K072146

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 Number07613353002640 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK072146 Date18 Dec 2007DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K072146 decided 18 Dec 2007 Active
  • FDA GUDID UDI-DI 07613353002640 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072146
  2. Listed FDA GUDID 07613353002640

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental ultrasonic surgical system handpiece tip
Model / Ref / Catalog
e, DS-101
Primary DI / UDI-DI
07613353002640
510(k) Number
FDA product code
DZI
GMDN term
Dental ultrasonic surgical system handpiece tip
Device class
Class II
Regulation number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Other devices from Electro Medical Systems (Ems Sa)

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

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)