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510(k) K253776

Implantmed Plus II & Piezomed Plus II Module by W&H Dentalwerk Buermoos GmbH — Product Code DZI

K253776 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "Implantmed Plus II & Piezomed Plus II Module". The FDA issued a decision of Substantially Equivalent on June 18, 2026. The device falls under product code DZI (Drill, Bone, Powered), a Class II device regulated under 21 CFR 872.4120. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 18, 2026
Date Received
November 26, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Drill, Bone, Powered
Device Class
Class II
Regulation Number
872.4120
Review Panel
DE
Submission Type

Other clearances by W&H Dentalwerk Buermoos GmbH

  • K243280 — Piezomed Pro (Piezomed Pro module M-PM100 incl. handpiece M-PH350, Piezomed Pro (July 3, 2025)
  • 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 DZI

  • K254163 — VarioSurg 4 (December 23, 2025)
  • K242432 — MT-Bone (August 19, 2024)
  • K240340 — Surgical Drive System (Model: ES70, ES90, E8) (July 18, 2024)
  • K231087 — Guided Surgery Kit (August 16, 2023)
  • K192561 — TRAUS SUS20 (July 13, 2020)
  • K200265 — Surgical Drills (June 30, 2020)
  • K192033 — Contour P-Insert 90, Contour P-Insert 45, Contour P-Insert Tri Tip, Contour P-In (June 9, 2020)
  • K172137 — PIEZOTOME CUBE (May 3, 2018)
  • K171326 — Piezosurgery White (April 13, 2018)
  • K171958 — PIEZOSURGERY TOUCH, PIEZOSURGERY WHITE (January 12, 2018)

FDA data resources