ChecQ (AC100)
FDA 510(k) K241065 · Dentis Co., Ltd.
510(k) numberK241065
Submission
- Device name
- ChecQ (AC100)
- Applicant
- Dentis Co., Ltd.
Daegu, KR - Received
- April 18, 2024
- Decision date
- March 21, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EKX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261987 | Reusable SmartPegEKX · Traditional | Osstell AB | 09/08/2026SE |
| K252223 | Alpha Endo Handpiece (Alpha Endo)EKX · Traditional | Shenzhen Superline Technology Co., Ltd. | 10/16/2025SE |
| K251597 | InnerView SystemEKX · Traditional | Perimetrics, Inc. | 09/18/2025SE |
| K243692 | EnDrive (EnDriveUS)EKX · Traditional | Advanced Technology Research (A.T.R.) S.R.L. | 08/22/2025SE |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO)EKX · Traditional | Shenzhen Rogin Medical Co., Ltd. | 04/24/2025SE |
| K243911 | HPR Cordless Hygiene HandpieceEKX · Traditional | Handpiece Headquarters | 12/20/2024SE |
| K222688 | The TrustEKX · Traditional | Genoss Co., Ltd. | 08/09/2024SE |
| K233865 | X-Smart Pro; X-Smart Pro+EKX · Traditional | Dentsply Sirona, Inc. | 07/24/2024SE |
| K232551 | EM-07 Cordless Endo MotorEKX · Traditional | Forum Engineering Technologies (96) , Ltd. | 07/09/2024SE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoitEKX · Traditional | Micro-Nx Co., Ltd. | 11/09/2023SE |
More from Micro-Nx Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K253493 | Dentis SQ-SL AXEL FixtureDZE · Traditional | 03/04/2026SE |
| K233921 | Luvis Chair (LC700C)KLC · Traditional | 09/06/2024SE |
| K241063 | s-Clean ScanHealing AbutmentNHA · Traditional | 07/25/2024SE |
| K240511 | Dentis s-Clean SQ-SL FixtureDZE · Traditional | 05/20/2024SE |
| K233544 | MesheetNXC · Traditional | 02/22/2024SE |
| K230126 | Dentis s-Clean Regular AbutmentNHA · Traditional | 08/04/2023SE |
| K230307 | Dentis i-Clean SystemNHA · Traditional | 07/11/2023SE |
| K230246 | Dentis s-Clean SQ-SL Narrow Implant SystemNHA · Traditional | 05/25/2023SE |
| K230523 | s-Clean Link Abutment NarrowNHA · Traditional | 05/24/2023SE |
| K230203 | Dentis I-FIX AbutmentNHA · Traditional | 05/03/2023SE |
Questions and answers
When was ChecQ (AC100) cleared by the FDA?
ChecQ (AC100) (K241065) received a 510(k) decision of Substantially Equivalent on March 21, 2025, 337 days after the submission was received.
What is the product code of K241065?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.