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Air-Flow

by E.M.S. Electro Medical Systems S.A. 64 variants

Air-Flow (EL-541A/A) is a dental abrasive air jet system handpiece (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K132478 on 11 Apr 2014 and listed in FDA GUDID since 25 Oct 2022 (UDI-DI 07613353180591), active as of 31 May 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 31 May 2026

Documents

510(k) K132478

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 31 May 2026.

Regulatory status

as of registry sync 31 May 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353180591 UDI-DI Date25 Oct 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK132478 Date11 Apr 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K132478 decided 11 Apr 2014 Active
  • FDA GUDID UDI-DI 07613353180591 listed 25 Oct 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132478
  2. Listed FDA GUDID 07613353180591

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Dental abrasive air jet system handpiece
Model / Ref / Catalog
F, EL-541A/A
Primary DI / UDI-DI
07613353180591
510(k) Number
FDA product code
EFB
GMDN term
Dental abrasive air jet system handpiece
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental abrasive air jet system handpiece

Cleared under the same submission (K132478)

and 8 more cleared under K132478

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

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)