Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
FDA 510(k) K243280 · W&H Dentalwerk Buermoos GmbH
510(k) numberK243280
Submission
- Device name
- Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)
- Applicant
- W&H Dentalwerk Buermoos GmbH
Buermoos, AT - Received
- October 17, 2024
- Decision date
- July 3, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 874.4250
- Specialty
- Ear, Nose, Throat
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| K181858 | Electric Handpiece MotorEBW · Traditional | 03/26/2019SE |
| K171553 | W&H Assistina TwinEFB · Traditional | 12/08/2017SE |
| K143704 | Advanced Air SystemEFB · Traditional | 11/23/2015SE |
| 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 |
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Questions and answers
When was Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) cleared by the FDA?
Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) (K243280) received a 510(k) decision of Substantially Equivalent on July 3, 2025, 259 days after the submission was received.
What is the product code of K243280?
The FDA product code is ERL – Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece, a Class II (moderate risk) device regulated under 21 CFR 874.4250.