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AIR-FLOW c

by E.M.S. Electro Medical Systems S.A. 56 variants

AIR-FLOW c (EL-354/B) is a Class I device made by E.M.S. Electro Medical Systems S.A., cleared under FDA 510(k) K110173 on 7 Apr 2011 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 07613353065331), 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) K110173

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 Number07613353065331 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK110173 Date7 Apr 2011DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K110173 decided 7 Apr 2011 Active
  • FDA GUDID UDI-DI 07613353065331 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K110173
  2. Listed FDA GUDID 07613353065331

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  • Withdrawn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 / Ref / Catalog
c, EL-354/B
Primary DI / UDI-DI
07613353065331
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

Other devices from Electro Medical Systems (Ems Sa)

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

Properties

  • Sterilise before use
  • Prescription use
  • Lot / batch number
Other properties (12, all answered No)