Cleared Traditional

ENDO ANALYZER, MODEL 8005, MODIFIED

K990225 · Sybron Dental Specialties, Inc. · Dental
Feb 1999
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K990225 is an FDA 510(k) clearance for the ENDO ANALYZER, MODEL 8005, MODIFIED, 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 February 25, 1999, 31 days after receiving the submission on January 25, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.1720.

Submission Details

510(k) Number K990225 FDA.gov
FDA Decision Cleared SESE
Date Received January 25, 1999
Decision Date February 25, 1999
Days to Decision 31 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