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510(k) K063321

D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 by Neks Technologies, Inc. — Product Code NBL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 30, 2007
Date Received
November 2, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Laser, Fluorescence Caries Detection
Device Class
Class II
Regulation Number
872.1745
Review Panel
DE
Submission Type

Other clearances by Neks Technologies, Inc.

  • K043156 — D-CARIE, MODEL N121-M1 (April 28, 2005)
  • K023367 — DETECTAR, MODEL N123-MI (June 25, 2003)

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