Piezomed
FDA 510(k) K133488 · W&H Dentalwerk Buermoos GmbH
510(k) numberK133488
Submission
- Device name
- Piezomed
- Applicant
- W&H Dentalwerk Buermoos GmbH
Burmoos, AT - Received
- November 13, 2013
- Decision date
- October 16, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code DZI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253655 | Angled Screwdriver MED (M-SD090)DZI · Traditional | W&H Dentalwerk Bürmoos GmbH | 07/31/2026SE |
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | W&H Dentalwerk Buermoos GmbH | 06/18/2026SE |
| K254163 | VarioSurg 4DZI · Traditional | Nakanishi, Inc. | 12/23/2025SE |
| K242432 | MT-BoneDZI · Traditional | Mectron S.P.A. | 08/19/2024SE |
| K240340 | Surgical Drive System (Model: ES70, ES90, E8)DZI · Traditional | Guangdong Jinme Medical Technology Co., Ltd. | 07/18/2024SE |
| K231087 | Guided Surgery KitDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 08/16/2023SE |
| K192561 | Traus SUS20DZI · Traditional | Saeshin Precision Co., Ltd. | 07/13/2020SE |
| K200265 | Surgical DrillsDZI · Traditional | Implant Direct Sybron Manufacturing, LLC | 06/30/2020SE |
| K192033 | Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-Insert WC…DZI · Traditional | Bennett Jacoby, Dds, Ms, Inc. | 06/09/2020SE |
| K172137 | Piezotome CubeDZI · Traditional | Satelec - Acteon Group | 05/03/2018SE |
More from Satelec - Acteon Group
| 510(k) | Device | Decision |
|---|---|---|
| K253776 | Implantmed Plus II & Piezomed Plus II ModuleDZI · Traditional | 06/18/2026SE |
| K243280 | Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro…ERL · Traditional | 07/03/2025SE |
| K201703 | PROXEO Twist Cordless Polishing System PL-40 HEKX · Traditional | 02/24/2021SE |
| 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 |
| 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 Piezomed cleared by the FDA?
Piezomed (K133488) received a 510(k) decision of Substantially Equivalent on October 16, 2014, 337 days after the submission was received.
What is the product code of K133488?
The FDA product code is DZI – Drill, Bone, Powered, a Class II (moderate risk) device regulated under 21 CFR 872.4120.