DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM— 510(k) K060287

Name: FDA 510(k) clearance K060287
Creator: U.S. Food and Drug Administration
Published: 2006-05-03

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

FDA 510(k) clearance K060287 for DRILLTECH, ISM, IMPLANTUNIT, ZIMMER SURGICAL MOTOR SYSTEM, Substantially Equivalent on 2006-05-03. Applicant: W&H Dentalwerk Buermoos GmbH. Device class: 1.

Clearance details

Applicant: W&H Dentalwerk Buermoos GmbH
Product code: Code EBW
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2006-02-06
Decision date: 2006-05-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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Recalls naming K060287

K-number listed on FDA's recall record

Z-1351-2018 — Foot Controls Model: S-N1 and S-N2 Product Usage: Variable foot control for use with drive units operating mechanical instruments.Class II·Terminated·W & H DentalWerk Burmoos GMBH - Site 1·20171221

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K060287.

Data sourced from openFDA. This site is unofficial and independent of the FDA.