Cleared Traditional

IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)

K002469 · W&H Dentalwerk Buermoos GmbH · Dental
Feb 2001
Decision
180d
Days
Class 1
Risk

About This 510(k) Submission

K002469 is an FDA 510(k) clearance for the IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V), a Controller, Foot, Handpiece And Cord (Class I — General Controls, product code EBW), submitted by W&H Dentalwerk Buermoos GmbH (Buermoos, AT). The FDA issued a Cleared decision on February 7, 2001, 180 days after receiving the submission on August 11, 2000. This device falls under the Dental review panel. Regulated under 21 CFR 872.4200.

Submission Details

510(k) Number K002469 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 2000
Decision Date February 07, 2001
Days to Decision 180 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code EBW — Controller, Foot, Handpiece And Cord
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.4200

Similar Devices — EBW Controller, Foot, Handpiece And Cord

All 60
Motor Handpiece and Control Unit (SDI10)
K251407 · Saeshin Precision Co., Ltd. · Jan 2026
Star E900 Electric System
K251701 · Dentalez, Inc., Stardental Division · Jan 2026
Motor and Apex Module (MaAM)
K251811 · Dentsply Sirona, Inc. · Aug 2025
ELEC ENGINE (Model: ISE-170L)
K231562 · Micro-Nx Co., Ltd. · Jul 2025
Dental Implant Unit
K242646 · Guilin Aesthedent Medical Instruments Co., Ltd. · Apr 2025
NLZ Built-In Motor System
K233288 · Nakanishi, Inc. · Jun 2024