EBW — Controller, Foot, Handpiece And Cord Class I
FDA product code EBW covers "Controller, Foot, Handpiece And Cord", a Class I medical device regulated under 21 CFR 872.4200. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- EBW
- Device Class
- Class I
- Regulation Number
- 872.4200
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K251407 | saeshin precision co | Motor Handpiece and Control Unit (SDI10) | January 30, 2026 |
| K251701 | dentalez, inc., stardental division | Star E900 Electric System | January 12, 2026 |
| K251811 | dentsply sirona | Motor and Apex Module (MaAM) | August 25, 2025 |
| K231562 | micro-nx co | ELEC ENGINE (Model: ISE-170L) | July 18, 2025 |
| K242646 | guilin aesthedent medical instruments co | Dental Implant Unit | April 11, 2025 |
| K233288 | nakanishi | NLZ Built-In Motor System | June 24, 2024 |
| K233117 | nakanishi | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) | June 20, 2024 |
| K230895 | cefla s.c | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 | April 1, 2024 |
| K231864 | codent technical industry co | Fiber Optic Brushless Electronic Micromotor, model: iM100 | March 11, 2024 |
| K211358 | guilin woodpecker medical instrument co | Implanter incl. Accessories | November 21, 2022 |
| K220831 | foshan coxo medical instrument co | Dental Implantation Systems, Dental Electrical Motors | September 27, 2022 |
| K213022 | cefla s.c | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMs, i-XR3, i-XR3 L, i-XS4, handy PO | May 9, 2022 |
| K202075 | foshan cicada dental instrument co | Dental Electric Motor | March 11, 2022 |
| K201191 | micro-nx co | ELEC-LED | February 7, 2022 |
| K203706 | guilin woodpecker medical instrument co | Dental Electric Motor | January 13, 2022 |
| K201192 | micro-nx co | Impla-NX (Model: ISE-270M) | May 21, 2021 |
| K201292 | saeshin precision co | TRAUS SIP20 | February 11, 2021 |
| K193341 | dentium co | iCTmotor (WL-1) | September 4, 2020 |
| K180845 | handpiece headquarters - hpr | Maxima Electric System | July 25, 2019 |
| K181858 | w and h dentalwerk buermoos | Electric Handpiece Motor | March 26, 2019 |