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510(k) K243280

Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories) by W&H Dentalwerk Buermoos GmbH — Product Code ERL

K243280 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro instruments (various tips) and accessories)". The FDA issued a decision of Substantially Equivalent on July 3, 2025. The device falls under product code ERL (Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece), a Class II device regulated under 21 CFR 874.4250. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 3, 2025
Date Received
October 17, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Surgical, Ent (Electric Or Pneumatic) Including Handpiece
Device Class
Class II
Regulation Number
874.4250
Review Panel
EN
Submission Type

Other clearances by W&H Dentalwerk Buermoos GmbH

  • K253776 — Implantmed Plus II & Piezomed Plus II Module (June 18, 2026)
  • K201703 — PROXEO Twist Cordless Polishing System PL-40 H (February 24, 2021)
  • K181858 — Electric Handpiece Motor (March 26, 2019)
  • K171553 — W&H Assistina Twin (December 8, 2017)
  • K143704 — Advanced Air System (November 23, 2015)
  • K133488 — PIEZOMED (October 16, 2014)
  • K100600 — PROSTHODONTIC SCREWDRIVER , MODEL IA-400 (July 9, 2010)
  • K083811 — W&H HANDPIECE ANESTO, MODEL: RA-5 (January 14, 2010)
  • K090931 — CORDLESS ENDO HANDPIECES EB-300, ENTRAN AND EB-300 S, S5 ENDO MOTOR (December 15, 2009)
  • K090548 — CONTRA-ANGLE HANDPIECE KOMET OS30 (June 30, 2009)

Other clearances for product code ERL

  • K233958 — hekaDrill (March 14, 2024)
  • K221184 — ORiGO System (November 2, 2022)
  • K213221 — AMADEO, M-UK1015 (incl. attachments and accessories) (May 26, 2022)
  • K212650 — Celeris, Disposable Sinus Debrider (January 19, 2022)
  • K211490 — Pi Drive 2 Motor / Model Number 5407-150-000, Pi Drive 2 Plus Motor / Model Numb (June 9, 2021)
  • K200318 — UNIDRIVE S II ENT, DrillCut-X II-35 Shaver Handpiece, DrillCut-X II-35 N Shaver (October 22, 2020)
  • K190715 — EndoRotor Console, EndoRotor Catheter, EndoRotor Specimen Trap, EndoRotor Filter (December 13, 2019)
  • K180063 — OCM-G1 Attachment (March 27, 2018)
  • K171840 — Stryker Consolidated Operating Room Equipment (CORE) 2 Console (September 15, 2017)
  • K163247 — 3.3 mm Laurimed Microdebrider; 4.0 mm Laurimed Microdebrider (March 9, 2017)

FDA data resources