Cleared Traditional

K910224 - THERMAPREP
(FDA 510(k) Clearance)

K910224 · Tulsa Dental Products, Ltd. · Dental device

Mar 1991

Decision

70d

Days

Class 1

Risk

K910224 is an FDA 510(k) clearance for the THERMAPREP. 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 29, 1991, 70 days after receiving the submission on January 18, 1991.

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

Submission Details

510(k) Number	K910224 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 18, 1991
Decision Date	March 29, 1991
Days to Decision	70 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	—