Electric Handpiece Motor
FDA 510(k) K181858 · W&H Dentalwerk Buermoos GmbH
510(k) numberK181858
Submission
- Device name
- Electric Handpiece Motor
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- July 12, 2018
- Decision date
- March 26, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K171553 | W&H Assistina TwinEFB · Traditional | 12/08/2017SE |
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| K133488 | PiezomedDZI · Traditional | 10/16/2014SE |
| K100600 | Prosthodontic Screwdriver , Model IA-400EKX · Traditional | 07/09/2010SE |
| K083811 | W&H Handpiece Anesto, Model: RA-5EGM · Traditional | 01/14/2010SE |
| K090931 | Cordless Endo Handpieces EB-300, Entran and EB-300 S, S5 Endo MotorEKX · Abbreviated | 12/15/2009SE |
| K090548 | Contra-Angle Handpiece Komet OS30EFB · Abbreviated | 06/30/2009SE |
Questions and answers
When was Electric Handpiece Motor cleared by the FDA?
Electric Handpiece Motor (K181858) received a 510(k) decision of Substantially Equivalent on March 26, 2019, 257 days after the submission was received.
What is the product code of K181858?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.