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Air-Flow

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

Air-Flow (EL-541E/HF) 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 1 Sep 2018 (UDI-DI 07613353046798), active as of 1 Jun 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 1 Jun 2026

Documents

510(k) K132478

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 1 Jun 2026.

Regulatory status

as of registry sync 1 Jun 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07613353046798 UDI-DI Date1 Sep 2018ListedStatusListed 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 07613353046798 listed 1 Sep 2018 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K132478
  2. Listed FDA GUDID 07613353046798

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  • Withdrawn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
a, EL-541E/HF
Primary DI / UDI-DI
07613353046798
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
Other properties (13, all answered No)