IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V)— 510(k) K002469

Name: FDA 510(k) clearance K002469
Creator: U.S. Food and Drug Administration
Published: 2001-02-07

Substantially Equivalent

W&H Dentalwerk Buermoos GmbH

FDA 510(k) clearance K002469 for IMPLANTMED SI-95 115 (100-130 V) AND SI-95 230 (220-240 V), Substantially Equivalent on 2001-02-07. 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: 2000-08-11
Decision date: 2001-02-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buermoos, AT

Download summary PDF View on FDA.gov ↗

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