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510(k) K052741

IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES by W&H Dentalwerk Buermoos GmbH — Product Code EBW

K052741 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Buermoos GmbH for the device "IMPLANTMED SI-915 (115V VERSION); IMPLANTMED SI-923 (230V VERSION) INCL. ACCESSORIES". The FDA issued a decision of Substantially Equivalent on January 13, 2006. The device falls under product code EBW (Controller, Foot, Handpiece And Cord), a Class I device regulated under 21 CFR 872.4200. W&H Dentalwerk Buermoos GmbH has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 13, 2006
Date Received
September 30, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Controller, Foot, Handpiece And Cord
Device Class
Class I
Regulation Number
872.4200
Review Panel
DE
Submission Type

Other clearances by W&H Dentalwerk Buermoos GmbH

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  • 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)

Other clearances for product code EBW

  • K251407 — Motor Handpiece and Control Unit (SDI10) (January 30, 2026)
  • K251701 — Star E900 Electric System (January 12, 2026)
  • K251811 — Motor and Apex Module (MaAM) (August 25, 2025)
  • K231562 — ELEC ENGINE (Model: ISE-170L) (July 18, 2025)
  • K242646 — Dental Implant Unit (April 11, 2025)
  • K233288 — NLZ Built-In Motor System (June 24, 2024)
  • K233117 — Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT) (June 20, 2024)
  • K230895 — CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3 (April 1, 2024)
  • K231864 — Fiber Optic Brushless Electronic Micromotor, model: iM100 (March 11, 2024)
  • K211358 — Implanter incl. Accessories (November 21, 2022)

FDA data resources