EXCEL HIGH SPEED DENTAL HANDPIECE— 510(k) K061581

Name: FDA 510(k) clearance K061581
Creator: U.S. Food and Drug Administration
Published: 2006-08-16

Substantially Equivalent

Orthosource, Inc.

FDA 510(k) clearance K061581 for EXCEL HIGH SPEED DENTAL HANDPIECE, Substantially Equivalent on 2006-08-16. Applicant: Orthosource, Inc.. Device class: 1.

Clearance details

Applicant: Orthosource, Inc.
Product code: Code EFA
Device class: Class 1
Regulation: 21 CFR 872.4200
Advisory panel: Dental
Date received: 2006-06-07
Decision date: 2006-08-16
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: North Hollywood, CA, US

Download summary PDF View on FDA.gov ↗

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