Young INFINITY Cordless Handpiece System
FDA 510(k) K171377 · Young Dental Manufacturing Co. 1, LLC
510(k) numberK171377
Submission
- Device name
- Young INFINITY Cordless Handpiece System
- Applicant
- Young Dental Manufacturing Co. 1, LLC
Earth City, MO, US - Received
- May 10, 2017
- Decision date
- August 20, 2018
- 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 |
| K241065 | ChecQ (AC100)EKX · Traditional | Dentis Co., Ltd. | 03/21/2025SE |
| 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 |
More from Forum Engineering Technologies (96) , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K241041 | Silver Fluoride Hypersensitivity VarnishPHR · Traditional | 02/28/2025SE |
| K201127 | DEFEND Ear-loop Face MasksFXX · Abbreviated | 04/14/2021SE |
| K153334 | Oral-B 5% Sodium Fluoride VarnishLBH · Traditional | 05/20/2016SE |
| K932255 | Young D'GranulatorKMW · Traditional | 04/15/1994SE |
| K903284 | Young Prophy System, PS UnitKOJ · Traditional | 12/17/1990SE |
| K875340 | Jetpolisher(Tm)KOJ · Traditional | 06/10/1988SE |
| K875339 | Jetpolisher Airpolishing PowderEJR · Traditional | 04/18/1988SE |
| K821484 | Dawn Low Speed Handpiece SystemEFB · Traditional | 06/09/1982SE |
| K790723 | Prophylaxis Cups and PolishersEHK · Traditional | 06/15/1979SE |
| K790722 | Prophylaxis AngleEGS · Traditional | 06/15/1979SE |
Questions and answers
When was Young INFINITY Cordless Handpiece System cleared by the FDA?
Young INFINITY Cordless Handpiece System (K171377) received a 510(k) decision of Substantially Equivalent on August 20, 2018, 467 days after the submission was received.
What is the product code of K171377?
The FDA product code is EKX – Handpiece, Direct Drive, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 872.4200.