510(k) K201703
- Device
- PROXEO Twist Cordless Polishing System PL-40 H
- Applicant
- W&H Dentalwerk Buermoos GmbH
- 510(k) number
- K201703
- Product code
- EKX
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2021-02-24
- Date received
- 2020-06-22
- Regulation
- 872.4200
- Classification name
- Handpiece, Direct Drive, Ac-powered
- Medical specialty
- Dental
- Review panel
- Dental
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- Johann Georg Scharl
- Address
- Ignaz Glaser Strasse 53 Buermoos AT AT - 5111 AT - 5111
FDA Registration Numbers#
- 3025599428
- 2243757
- 3002807636
- 3009727738
- 3006540014
- 2086043
- 2433629
- 3017399129
- 3004431266
- 3017604
- 3033509587
- 3007279848
- 3008770655
- 3003637274
- 3004884150
- 2024949
- 3019381139
- 2511556
- 2424472
- 8010468
- 3038718579
- 8044015
- 3001082453
- 3010373494
- 3004443656
- 3014330970
- 3008249935
- 3011300255
- 3006444232
- 3005581016
- 3009431661
- 2520265
- 3003610374
- 3008544850
- 3007126709
- 3011276344
- 3007007357
- 2416455
- 3039642990
- 3015729
- 8043962
- 1032227
- 3015136927
- 1422375
- 3011944170
- 9614977
- 3007663058
- 3017618678
- 3030126955
- 3004070020
- 3014953747
- 3008590661
- 3005972890
- 2832
- 3011824442
- 3008559295
- 3013206323
- 2183301
- 9611253
- 1718912
- 2127132
- 3007958831
- 3000219976
- 1054713
- 1941138
- 1419489
- 3018783058
- 3005481202
- 3016875543
- 9681479
- 9614866
- 3025764223
- 3009768364
- 1223843
- 2020943
- 3019741877
- 3008812251
- 3006223010
- 3014683120
- 3007345485
Source Documents#
Other 510(k) Records For Product Code EKX #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252223 | Alpha Endo Handpiece (Alpha Endo) | SHENZHEN SUPERLINE TECHNOLOGY CO., LTD. | 2025-10-16 |
| K251597 | InnerView System | Perimetrics, Inc. | 2025-09-18 |
| K243692 | EnDrive (EnDriveUS) | Advanced Technology Research (A.T.R.) S.R.L. | 2025-08-22 |
| K242514 | Endo Motor (E-LITE MAX, E-LITE PRO, E-LITE INO) | Shenzhen Rogin Medical Co., Ltd. | 2025-04-24 |
| K241065 | ChecQ (AC100) | Dentis Co., Ltd. | 2025-03-21 |
| K243911 | HPR Cordless Hygiene Handpiece | Handpiece Headquarters | 2024-12-20 |
| K222688 | The Trust | Genoss Co., Ltd. | 2024-08-09 |
| K233865 | X-Smart Pro; X-Smart Pro+ | Dentsply Sirona, Inc. | 2024-07-24 |
| K232551 | EM-07 Cordless Endo Motor | Forum Engineering Technologies (96) , Ltd. | 2024-07-09 |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoit | Micro-Nx Co., Ltd. | 2023-11-09 |
| K232657 | InnerView LC | Perimetrics, Inc. | 2023-09-01 |
| K220829 | Endo Motor | Foshan Coxo Medical Instrument Co., Ltd. | 2023-05-18 |
| K222548 | Endo Motor | Shenzhen Perfect Medical Instruments Co., Ltd. | 2023-04-26 |
| K210475 | EQ-M | Meta Systems Co., Ltd. | 2022-09-21 |
| K213897 | Pro M Class | Saeyang Microtech Co., Ltd. | 2022-09-19 |
Legacy Summary#
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FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases