Cleared Traditional

MILLENNIUM

K990908 · Endo Technic Corp. · Dental
May 1999
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K990908 is an FDA 510(k) clearance for the MILLENNIUM, a System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation (Class II — Special Controls, product code MXF), submitted by Endo Technic Corp. (San Clemente, US). The FDA issued a Cleared decision on May 27, 1999, 70 days after receiving the submission on March 18, 1999. This device falls under the Dental review panel. Regulated under 21 CFR 872.4120.

Submission Details

510(k) Number K990908 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1999
Decision Date May 27, 1999
Days to Decision 70 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code MXF — System, Dental, Hydrokinetic, Caries Removal & Cavity Preparation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.4120