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MK-dent ACCESSORIES

by MK-Dent GmbH 19 variants

MK-dent ACCESSORIES (QC4014W) is a Class I device made by MK-Dent GmbH, cleared under FDA 510(k) K032234 on 2 Oct 2003 and listed in FDA GUDID since 14 Oct 2024 (UDI-DI E490QC4014W1), 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) K032234

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 NumberE490QC4014W1 UDI-DI Date14 Oct 2024ListedStatusListed 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 E490QC4014W1 listed 14 Oct 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K032234
  2. Listed FDA GUDID E490QC4014W1

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
MK-dent
Generic name
Pneumatic dental handpiece coupler
Model / Ref / Catalog
ACCESSORIES, QC4014W
Primary DI / UDI-DI
E490QC4014W1
510(k) Number
FDA product code
EFB
GMDN term
Pneumatic dental handpiece coupler
Device class
Class I
Regulation number
872.4200
GUDID distribution status
In Commercial Distribution

Related devices

Category: Pneumatic dental handpiece coupler

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 MK-Dent GmbH

See all devices from MK-Dent GmbH →

Properties

  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (12, all answered No)