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Flight Dental Systems LCH11

by Flight Dental Systems

Flight Dental Systems LCH11 is a dental power tool system handpiece (FDA Class I; FDA product code EFB, Handpiece, Air-Powered, Dental) made by Flight Dental Systems, cleared under FDA 510(k) K032234 on 2 Oct 2003 and listed in FDA GUDID since 27 Jan 2022 (UDI-DI D884LCH1100), 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) K032234

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 NumberD884LCH1100 UDI-DI Date27 Jan 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK032234 Date2 Oct 2003DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K032234 decided 2 Oct 2003 Active
  • FDA GUDID UDI-DI D884LCH1100 listed 27 Jan 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032234
  2. Listed FDA GUDID D884LCH1100

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  • Withdrawn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
Dental power tool system handpiece, pneumatic
Model / reference
LCH11
Primary DI / UDI-DI
D884LCH1100
510(k) Number
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

Related devices

Category: Dental power tool system handpiece, pneumatic

Cleared under the same submission (K032234)

and 8 more cleared under K032234

Similar devices

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

Other devices from Flight Dental Systems

See all devices from Flight Dental Systems →

Properties

  • Sterilise before use
  • Serial number
Other properties (13, all answered No)