Cleared Traditional

K013993 - NEOCALEX
(FDA 510(k) Clearance)

K013993 · Stephen M Koral, Dmd · Dental device

Feb 2002

Decision

80d

Days

Class 1

Risk

K013993 is an FDA 510(k) clearance for the NEOCALEX. This device is classified as a Carver, Wax, Dental (Class I - General Controls, product code EIK).

Submitted by Stephen M Koral, Dmd (Boulder, US). The FDA issued a Cleared decision on February 22, 2002, 80 days after receiving the submission on December 4, 2001.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4565.

Submission Details

510(k) Number	K013993 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 04, 2001
Decision Date	February 22, 2002
Days to Decision	80 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement