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510(k) K013993

NEOCALEX by Stephen M Koral, Dmd — Product Code EIK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 2002
Date Received
December 4, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Carver, Wax, Dental
Device Class
Class I
Regulation Number
872.4565
Review Panel
DE
Submission Type

Other clearances by Stephen M Koral, Dmd

  • K010176 — CALEX CONDITIONER (March 27, 2001)

Other clearances for product code EIK

  • K972642 — PERIO CONTROL II (January 26, 1998)
  • K902653 — PDS-2000 (September 13, 1990)
  • K860817 — ROOT CANAL ORGANIZER (March 17, 1986)
  • K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA (July 2, 1985)