Flight Dental Systems Clave8+

• FDA 510(k) K243994 decided 6 Jun 2025 Active
• FDA GUDID UDI-DI D178CLAVE8 listed 18 Jul 2025 Listed

1. 6 Jun 2025 Cleared FDA 510(k) K243994
2. 18 Jul 2025 Listed FDA GUDID D178CLAVE8

Trade name

Flight Dental Systems

Generic name

Steam sterilizer

Model / Ref / Catalog

Clave8+

Primary DI / UDI-DI

D178CLAVE8

510(k) Number

K243994 ↗

FDA product code

FLE

GMDN term

Steam sterilizer

Device class

Class II

Regulation number

880.6880

GUDID distribution status

In Commercial Distribution

Category: Steam sterilizer

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

• AMSCO 400 Small Steam Sterilizers, AMSCO 400 Medium Steam Sterilizers by STERIS CORPORATION
• FRONT-LINE Field Sterilizer (FL135) by Fort Defiance Industries, Inc.
• CASTLE 400HC/500HC SERIES STEAM STERILIZER, MODELS 422HC, 433HC, 522HC, AND 533HC by Getinge/Castle, Inc.
• HARVARD/LTE BENCHTOP STEAM STERILIZER (AUTOCLAVE) by Harvard Apparatus, Inc.
• STERILIZER, SURG INSTR/DRESSING #6530-01-306-9510 by Dept. of the Army
• CRADLING SYSTEM by Medin Corp.
• MODIFICATION OF: MIDMARK M-11 ULTRACLAVE STEAM STERILIZER by Midmark Corporation
• PRESTIGE MEDICAL SERIES 2100 CLINICAL AUTOCLAVE by Prestige Medical
• ACCESS (POWERCLAVE) by Mdt Biologic Co.
• CLS-2000 UNIT by Dentsply Intl.

• Flight Dental Systems A6EP-102

  Class I

  FDA 510(k) K070196 Active Cleared 26 Jan 2007 GUDID on market

• Flight Dental Systems A6EP-100

  Class I

  FDA 510(k) K070196 Active Cleared 26 Jan 2007 GUDID on market

• Flight Dental Systems QC-165K

  Class I

  FDA 510(k) K181691 Active Cleared 26 May 2020 GUDID on market

• Flight Dental Systems A12H

  Class I

  GUDID on market

See all devices from Flight Dental Systems USA Inc. →