Cleared Traditional

K922931 - THERMAPOST ENDODONTIC ROOT CANAL POST
(FDA 510(k) Clearance)

May 1994
Decision
708d
Days
Class 1
Risk

K922931 is an FDA 510(k) clearance for the THERMAPOST ENDODONTIC ROOT CANAL POST. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by Tulsa Dental Products, Ltd. (Tulsa, US). The FDA issued a Cleared decision on May 26, 1994, 708 days after receiving the submission on June 17, 1992.

This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.3810.

Submission Details

510(k) Number K922931 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 17, 1992
Decision Date May 26, 1994
Days to Decision 708 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELR — Post, Root Canal
Device Class Class I - General Controls
CFR Regulation 21 CFR 872.3810