Home / 510(k) Clearances / K161957

510(k) K161957

W&H Implantmed SI-1015 incl. Accessories by W&H Dentalwerk Burmoos GmbH — Product Code EBW

K161957 is an FDA 510(k) premarket notification submitted by W&H Dentalwerk Burmoos GmbH for the device "W&H Implantmed SI-1015 incl. Accessories". The FDA issued a decision of Substantially Equivalent on Nov 23, 2016. 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 Burmoos GmbH has 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 23, 2016
Date Received
Jul 18, 2016
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
510(k)

Other clearances by W&H Dentalwerk Burmoos GmbH

  • K162926 — Air-Powered Handpieces and Handpiece Attachments (Feb 23, 2017)
  • K041124 — IRRIGATION TUBING SET 2.2M AND 3.8M (Jun 7, 2004)

Other clearances for product code EBW

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

FDA data resources