Cleared Traditional

SYSTEM B HEAT SOURCE

K970715 · Sybron Dental Specialties, Inc. · Dental
Apr 1997
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K970715 is an FDA 510(k) clearance for the SYSTEM B HEAT SOURCE, a Tester, Pulp (Class II — Special Controls, product code EAT), submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on April 7, 1997, 39 days after receiving the submission on February 27, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K970715 FDA.gov
FDA Decision Cleared SESE
Date Received February 27, 1997
Decision Date April 07, 1997
Days to Decision 39 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code EAT — Tester, Pulp
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1720