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MK-dent PRIME LINE

by MK-Dent GmbH 3 variants

Ref HC8021K

MK-dent PRIME LINE (HC8021K) is a device classified as Class IIa in the EU and Class I in the US made by MK-Dent GmbH, registered in EUDAMED on 16 Sep 2026 (Basic UDI-DI B-+E490HC8021K10), cleared under FDA 510(k) K032234 on 2 Oct 2003 and listed in FDA GUDID since 14 Oct 2024 (UDI-DI +E490HC8021K10), active as of 23 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K032234

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-+E490HC8021K10 Basic UDI-DI +E490HC8021K10UDI-DIDate16 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number+E490HC8021K10 UDI-DI Date14 Oct 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK032234 Date2 Oct 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-+E490HC8021K10 registered 16 Sep 2026 Active
  • FDA 510(k) K032234 decided 2 Oct 2003 Active
  • FDA GUDID UDI-DI +E490HC8021K10 listed 14 Oct 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K032234
  2. Listed FDA GUDID +E490HC8021K10
  3. Registered EUDAMED B-+E490HC8021K10

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Turbine EUDAMED
MK-dent GUDID
Generic name
Dental power tool handpiece motorless component
Device name
PRIME LINE High Speed Handpiece
Model / Ref / Catalog
HC8021K, PRIME LINE
Primary DI / UDI-DI
+E490HC8021K10 EUDAMED
E490HC8021K1 GUDID
Basic UDI-DI
B-+E490HC8021K10
510(k) Number
FDA product code
EFB
EMDN code
Q010199 Conservative dentistry and endodontics devices - other
GMDN term
Dental power tool handpiece motorless component
Device class
Class IIa EUDAMED
Class I GUDID
Regulation number
872.4200
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
HC8021K
GUDID
PRIME LINE
Primary DI / UDI-DIEUDAMED
+E490HC8021K10
GUDID
E490HC8021K1
Device classEUDAMED
Class IIa
GUDID
Class I

The registries describe this device under different primary UDI-DIs (EUDAMED lists +E490HC8021K10; FDA GUDID lists E490HC8021K1), so their flags are not compared. Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class I in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental power tool handpiece motorless component

Cleared under the same submission (K032234)

and 8 more cleared under K032234

Similar devices in this category

Other devices filed under CONSERVATIVE DENTISTRY AND ENDODONTICS DEVICES - OTHER.

Other devices from MK-Dent GmbH

See all devices from MK-Dent GmbH →

Properties

  • Sterilise before use
  • Over-the-counter
  • Serial number
  • Manufacturing date
Other properties (19, all answered No)