KI-20
FDA 510(k) K141482 · Saeyang Microtech Co., Ltd.
510(k) numberK141482
Submission
- Device name
- KI-20
- Applicant
- Saeyang Microtech Co., Ltd.
Fullerton, CA, US - Received
- June 4, 2014
- Decision date
- April 24, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBW
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|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10)EBW · Traditional | Saeshin Precision Co., Ltd. | 01/30/2026SE |
| K251701 | Star E900 Electric SystemEBW · Traditional | Dentalez, Inc., Stardental Division | 01/12/2026SE |
| K251811 | Motor and Apex Module (MaAM)EBW · Traditional | Dentsply Sirona, Inc. | 08/25/2025SE |
| K231562 | ELEC ENGINE (Model: ISE-170L)EBW · Special | Micro-Nx Co., Ltd. | 07/18/2025SE |
| K242646 | Dental Implant UnitEBW · Traditional | Guilin Aesthedent Medical Instruments Co., Ltd. | 04/11/2025SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | Nakanishi, Inc. | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | Nakanishi, Inc. | 06/20/2024SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | Cefla S.C. | 04/01/2024SE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/21/2022SE |
More from Guilin Woodpecker Medical Instrument Co., Ltd.
Questions and answers
When was KI-20 cleared by the FDA?
KI-20 (K141482) received a 510(k) decision of Substantially Equivalent on April 24, 2015, 324 days after the submission was received.
What is the product code of K141482?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.