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OK-Handpiece

by Jaintek Co., Ltd.

Ref OKH4

OK-Handpiece (OKH4) is a medical device (EU MDR Class IIa; EMDN category instruments for dental treatment units) made by Jaintek Co., Ltd., registered in EUDAMED on 9 May 2025 (Basic UDI-DI 88001152H-0001PL) and cleared under FDA 510(k) K221814 on 15 Jul 2022, active as of 24 Oct 2026.

Active European Union and United States

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K221814↗

FDA record

Trust

Unverified

Source EUDAMED, FDA 510(k), synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88001152H-0001PL Basic UDI-DI 08800115200010UDI-DIDate9 May 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK221814 Date15 Jul 2022IssuedStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88001152H-0001PL registered 9 May 2025 Active
  • FDA 510(k) K221814 decided 15 Jul 2022 Active

Timeline

2 dated events

  1. Cleared FDA 510(k) K221814
  2. Registered EUDAMED 88001152H-0001PL

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Device name
Low Speed Dental Handpiece, pneumatic
Model / reference
OKH4
Primary DI / UDI-DI
08800115200010
Basic UDI-DI
88001152H-0001PL, B-08800115200010
EMDN code
Z12110199 Instruments for dental treatment units - other
Device class
Class IIa
EU registration type
Standard device
Legacy device (under a directive)
EU market of registration
Poland

Manufacturer details

EUDAMED SRN
KR-MF-000045113
Authorised representative
KTR Europe GmbH DE-AR-000005685

Similar devices in this category

Other devices filed under INSTRUMENTS FOR DENTAL TREATMENT UNITS - OTHER.

Other devices from Jaintek Co., Ltd.

See all devices from Jaintek Co., Ltd. →

Properties

  • Supplied sterile
  • Sterilise before use
  • Reusable
Other properties (11, all answered No)