Cleared Traditional

ENDO ANALYZER, MODEL 8005

K973439 · Sybron Dental Specialties, Inc. · Dental
Dec 1997
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K973439 is an FDA 510(k) clearance for the ENDO ANALYZER, MODEL 8005, 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 December 8, 1997, 89 days after receiving the submission on September 10, 1997. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K973439 FDA.gov
FDA Decision Cleared SESE
Date Received September 10, 1997
Decision Date December 08, 1997
Days to Decision 89 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