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Flight Dental Systems Clave23+

by Flight Dental Systems USA Inc.

Flight Dental Systems Clave23+ is a steam sterilizer (FDA Class II; FDA product code FLE, Sterilizer, Steam) made by Flight Dental Systems USA Inc., cleared under FDA 510(k) K243994 on 6 Jun 2025 and listed in FDA GUDID since 18 Jul 2025 (UDI-DI D178CLAVE23), active as of 22 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 22 Oct 2026

Documents

510(k) K243994

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD178CLAVE23 UDI-DI Date18 Jul 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK243994 Date6 Jun 2025DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K243994 decided 6 Jun 2025 Active
  • FDA GUDID UDI-DI D178CLAVE23 listed 18 Jul 2025 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K243994
  2. Listed FDA GUDID D178CLAVE23

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Flight Dental Systems
Generic name
Steam sterilizer
Model / Ref / Catalog
Clave23+
Primary DI / UDI-DI
D178CLAVE23
510(k) Number
FDA product code
FLE
GMDN term
Steam sterilizer
Device class
Class II
Regulation number
880.6880
GUDID distribution status
In Commercial Distribution

Related devices

Category: Steam sterilizer

Cleared under the same submission (K243994)

Similar devices

Other devices filed under FDA product code FLE (Sterilizer, Steam).

Other devices from Flight Dental Systems USA Inc.

See all devices from Flight Dental Systems USA Inc. →

Properties

  • Serial number
  • Manufacturing date
Other properties (13, all answered No)