Cleared Traditional

K823486 - TOUCH-N-HEAT MODEL 5001
(FDA 510(k) Clearance)

K823486 · Analytic Technology · Dental device

Jan 1983

Decision

56d

Days

Class 1

Risk

K823486 is an FDA 510(k) clearance for the TOUCH-N-HEAT MODEL 5001. This device is classified as a Gutta-percha (Class I - General Controls, product code EKM).

Submitted by Analytic Technology (Walker, US). The FDA issued a Cleared decision on January 18, 1983, 56 days after receiving the submission on November 23, 1982.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3850.

Submission Details

510(k) Number	K823486 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	November 23, 1982
Decision Date	January 18, 1983
Days to Decision	56 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—