Cleared Traditional

K970134 - THERMAPREP PLUS OVEN
(FDA 510(k) Clearance)

K970134 · Tulsa Dental Products, Ltd. · Dental
Mar 1997
Decision
65d
Days
Class 1
Risk

K970134 is an FDA 510(k) clearance for the THERMAPREP PLUS OVEN. This device is classified as a Gutta-percha (Class I — General Controls, product code EKM).

Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on March 21, 1997, 65 days after receiving the submission on January 15, 1997.

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

Submission Details

510(k) Number K970134 FDA.gov
FDA Decision Cleared SESE
Date Received January 15, 1997
Decision Date March 21, 1997
Days to Decision 65 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EKM — Gutta-percha
Device Class Class I — General Controls
CFR Regulation 21 CFR 872.3850