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ChecQ AC100

by Dentis Co., Ltd

Model AC100

ChecQ AC100 is a medical device (EU MDR Class I; FDA Class I; FDA product code EKX, Handpiece, Direct Drive, Ac-Powered; EMDN category odontology devices) made by Dentis Co., Ltd, registered in EUDAMED on 5 Jun 2026 (Basic UDI-DI 88000530DISAKB), cleared under FDA 510(k) K241065 on 21 Mar 2025 and listed in FDA GUDID since 31 Mar 2025 (UDI-DI 08800053084123), active as of 23 Oct 2026.

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

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 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K241065

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/MDR EUDAMED Number88000530DISAKB Basic UDI-DI 08800053084123UDI-DIDate5 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800053084123 UDI-DI Date31 Mar 2025ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK241065 Date21 Mar 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 88000530DISAKB registered 5 Jun 2026 Active
  • FDA 510(k) K241065 decided 21 Mar 2025 Active
  • FDA GUDID UDI-DI 08800053084123 listed 31 Mar 2025 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K241065
  2. Listed FDA GUDID 08800053084123
  3. Registered EUDAMED 88000530DISAKB

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
ChecQ
Generic name
Dental implant stability resonance frequency analysis unit
Model / reference
AC100
Primary DI / UDI-DI
08800053084123
Basic UDI-DI
88000530DISAKB
Direct marketing DI
08800053084123
510(k) Number
FDA product code
EKX
EMDN code
Q0199 Odontology devices - other
GMDN term
Dental implant stability resonance frequency analysis unit
Device class
Class I
Regulation number
872.4200
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Dental implant stability resonance frequency analysis unit

Cleared under the same submission (K241065)

Similar devices in this category

Other devices filed under ODONTOLOGY DEVICES - OTHER.

Other devices from Dentis Co., Ltd

See all devices from Dentis Co., Ltd →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)