Cleared Traditional

SPLINT IT

K972985 · Jeneric/Pentron, Inc. · Dental
Sep 1997
Decision
44d
Days
Class 2
Risk

About This 510(k) Submission

K972985 is an FDA 510(k) clearance for the SPLINT IT, a Splint, Endodontic Stabilizing (Class II — Special Controls, product code ELS), submitted by Jeneric/Pentron, Inc. (Wallingford, US). The FDA issued a Cleared decision on September 24, 1997, 44 days after receiving the submission on August 11, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.3890.

Submission Details

510(k) Number K972985 FDA.gov
FDA Decision Cleared SESE
Date Received August 11, 1997
Decision Date September 24, 1997
Days to Decision 44 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code ELS — Splint, Endodontic Stabilizing
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.3890