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Piezon En-049#B/001

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

Piezon En-049#B/001 is a dental ultrasonic surgical system handpiece (FDA Class II; FDA product code DZI, Drill, Bone, Powered) 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 9 Jul 2020 (UDI-DI 07613353048754), 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) K072146

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 Number07613353048754 UDI-DI Date9 Jul 2020ListedStatusListed 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 07613353048754 listed 9 Jul 2020 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K072146
  2. Listed FDA GUDID 07613353048754

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Piezon
Generic name
Dental ultrasonic surgical system handpiece
Model / reference
EN-049#B/001
Primary DI / UDI-DI
07613353048754
510(k) Number
FDA product code
DZI
GMDN term
Dental ultrasonic surgical system handpiece
Device class
Class II
Regulation number
872.4120
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 (K072146)

and 8 more cleared under K072146

Similar devices

Other devices filed under FDA product code DZI (Drill, Bone, Powered).

Other devices from Electro Medical Systems (Ems Sa)

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

Properties

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