NEOCALEX— 510(k) K013993

Substantially Equivalent

Stephen M Koral, Dmd

FDA 510(k) clearance K013993 for NEOCALEX, Substantially Equivalent on 2002-02-22. Applicant: Stephen M Koral, Dmd. Device class: 1.

Clearance details

Applicant: Stephen M Koral, Dmd
Product code: Code EIK
Device class: Class 1
Regulation: 21 CFR 872.4565
Advisory panel: Dental
Date received: 2001-12-04
Decision date: 2002-02-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Boulder, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code EIK

K972642 — PERIO CONTROL II1998-01-26
K902653 — PDS-20001990-09-13
K860817 — ROOT CANAL ORGANIZER1986-03-17
K851727 — 2020-1/2 TO 2220 VARIOUS DENTAL WAX & MODELLING CA1985-07-02

More clearances from Stephen M Koral, Dmd

K010176 — CALEX CONDITIONER2001-03-27

Data sourced from openFDA. This site is unofficial and independent of the FDA.