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AIR-FLOW-PIEZON FT-229Default

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

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

3 ongoing

This device is named in the recall

Documents

None

No authorization documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353257224 UDI-DI Date20 Oct 2025ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · 3 ongoing · FDA

  • 3 recalls, same reason

    • Ongoing Z-1686-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1687-2024 FDA Class II initiated 13 Mar 2024
    • Ongoing Z-1688-2024 FDA Class II initiated 13 Mar 2024

    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).

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Air-Flow-Piezon
Generic Name
Chairside dental abrasive air jet system
Model / Reference
FT-229Default
Primary DI / UDI-DI
07613353257224
510(k) Number
FDA Product Code
ELC
GMDN Term
Chairside dental abrasive air jet system
Device Class
Class II
Regulation Number
872.4850
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Cleared under the same submission (K190124)

Show all (12)

Other devices from Electro Medical Systems (Ems Sa)

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

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No