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510(k) K023367

DETECTAR, MODEL N123-MI by Neks Technologies — Product Code EJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 25, 2003
Date Received
October 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Handle, Instrument, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Neks Technologies

  • K063321 — D-CARIE/DETECTAR, MODELS N121, N123, N133, N134, N135 & N138 (March 30, 2007)
  • K043156 — D-CARIE, MODEL N121-M1 (April 28, 2005)

Other clearances for product code EJB

  • K140144 — BENDA WEDGE (July 8, 2014)
  • K981234 — FLARE,FILE, FILL (June 5, 1998)
  • K930094 — AUKUSLEEVE (October 20, 1993)
  • K922633 — CAVI-ZYME (August 6, 1992)
  • K871818 — SPATULA, DENTAL, CEMENT (July 2, 1987)
  • K833338 — TOOTH SLOOTH (November 25, 1983)
  • K823913 — SOFT GRIP UNI-HANDLE (January 26, 1983)