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Air-Flow El-354#MX

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

Air-Flow El-354#MX is a Class I device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K190124 on 20 Oct 2019 and listed in FDA GUDID since 7 Jul 2025 (UDI-DI 07613353342074), 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

3 ongoing

Recall on shared 510(k) K190124; other models may be affected

Documents

510(k) K190124

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 Number07613353342074 UDI-DI Date7 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK190124 Date20 Oct 2019DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K190124 decided 20 Oct 2019 Active
  • FDA GUDID UDI-DI 07613353342074 listed 7 Jul 2025 Listed

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1686-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124
    • Ongoing Z-1687-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124
    • Ongoing Z-1688-2024 FDA Class II initiated 13 Mar 2024 on shared 510(k) K190124

    Received complaints that bottles assembled with one batch of bottle collars can be disassembled in two parts when used under pressure (during treatment or storage if the use is not releasing the pressure inside the bottles).

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

5 dated events

  1. Cleared FDA 510(k) K190124
  2. Recall initiated FDA recalls Z-1686-2024
  3. Recall initiated FDA recalls Z-1687-2024
  4. Recall initiated FDA recalls Z-1688-2024
  5. Listed FDA GUDID 07613353342074

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Air-Flow
Generic name
Chairside dental abrasive air jet system
Model / reference
EL-354#MX
Primary DI / UDI-DI
07613353342074
510(k) Number
FDA product code
EFB
GMDN term
Chairside dental abrasive air jet system
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Dental abrasive air jet system

Cleared under the same submission (K190124)

and 8 more cleared under K190124

Similar devices

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

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)