Cleared Traditional

SMEARCLEAR

K024198 · Sybron Dental Specialties, Inc. · Dental
Mar 2003
Decision
75d
Days
—
Risk

About This 510(k) Submission

K024198 is an FDA 510(k) clearance for the SMEARCLEAR, a Cleanser, Root Canal, submitted by Sybron Dental Specialties, Inc. (Orange, US). The FDA issued a Cleared decision on March 5, 2003, 75 days after receiving the submission on December 20, 2002. This device falls under the Dental review panel.

Submission Details

510(k) Number K024198 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 2002
Decision Date March 05, 2003
Days to Decision 75 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code KJJ — Cleanser, Root Canal
Device Class —