Flight Dental Systems LE11

• FDA 510(k) K032234 decided 2 Oct 2003 Active
• FDA GUDID UDI-DI D884LE1100 listed 27 Jan 2022 Listed

1. 2 Oct 2003 Cleared FDA 510(k) K032234
2. 27 Jan 2022 Listed FDA GUDID D884LE1100

Trade name

Flight Dental Systems

Generic name

Dental power tool system handpiece, pneumatic

Model / reference

LE11

Primary DI / UDI-DI

D884LE1100

510(k) Number

K032234 ↗

FDA product code

EFB

GMDN term

Dental power tool system handpiece, pneumatic

Device class

Class I

Regulation number

872.4200

GUDID distribution status

In Commercial Distribution

Sterilisation method

Moist Heat or Steam Sterilization

Category: Dental power tool system handpiece, pneumatic

Other devices filed under FDA product code EFB (Handpiece, Air-Powered, Dental).

• CHALLENGER/CLASSIC PUSH BUTTON HANDPIECE by Promident, LLC
• INTEGRITY LOW SPEED DENTAL AIR HANDPIECE AND ATTACHMENT, MODELS: MOTOR INT-E, MOTOR INT-D AND ATTACHMENT INT-SNC by OSSEO SCIENTIFIC, LLC
• CODENT LOW SPEED DENTAL HANDPIECES AND ACCESSORIES by CODENT TECHNICAL INDUSTRY CO.,LTD
• LYNX LOW-SPEED HANDPIECE by Air Motors Technologies
• Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece by Shenzhen Carejoy Technology Co., Ltd.
• MIDWEST 300 SE by Midwest Dental Products Corp.
• T2 LINE 6376201 by SIRONA Dental Systems GmbH
• TEK-LUBE by Clinical Technology Corp.
• I-SURGE by Satelec
• ALLRAP/SLIP-N-GRIP by Dental Disposables Intl., Inc.

• Flight Dental Systems F-411CA

  Class I

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

• Flight Dental Systems BI-2530K

  Class II

  FDA 510(k) K040396 Active Cleared 22 Apr 2004 GUDID on market

• Flight Dental Systems FMS-2530

  Class II

  FDA 510(k) K040396 Active Cleared 22 Apr 2004 GUDID on market

• Medidenta - Air Free 45 Titan AFT45

  Class I

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

See all devices from Flight Dental Systems →