Cleared Traditional

K030820 - EVERSTICK POST
(FDA 510(k) Clearance)

May 2003
Decision
67d
Days
Class 1
Risk

K030820 is an FDA 510(k) clearance for the EVERSTICK POST. This device is classified as a Post, Root Canal (Class I - General Controls, product code ELR).

Submitted by Stick Tech , Ltd. (Mount Vernon, US). The FDA issued a Cleared decision on May 20, 2003, 67 days after receiving the submission on March 14, 2003.

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

Submission Details

510(k) Number K030820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2003
Decision Date May 20, 2003
Days to Decision 67 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

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