D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138— 510(k) K063321

Name: FDA 510(k) clearance K063321
Creator: U.S. Food and Drug Administration
Published: 2007-03-30

Substantially Equivalent

Neks Technologies, Inc.

FDA 510(k) clearance K063321 for D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138, Substantially Equivalent on 2007-03-30. Applicant: Neks Technologies, Inc.. Device class: 2.

Clearance details

Applicant: Neks Technologies, Inc.
Product code: Code NBL
Device class: Class 2
Regulation: 21 CFR 872.1745
Advisory panel: Dental
Date received: 2006-11-02
Decision date: 2007-03-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laval, Quebec, CA

Download summary PDF View on FDA.gov ↗

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