Cleared Traditional

DIAGNODENT

K051909 · Kavo America · Dental
Oct 2005
Decision
99d
Days
Class 2
Risk

About This 510(k) Submission

K051909 is an FDA 510(k) clearance for the DIAGNODENT, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Kavo America (Deer Field, US). The FDA issued a Cleared decision on October 21, 2005, 99 days after receiving the submission on July 14, 2005. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K051909 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2005
Decision Date October 21, 2005
Days to Decision 99 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF

Device Classification

Product Code NBL — Laser, Fluorescence Caries Detection
Device Class Class II — Special Controls
CFR Regulation 21 CFR 872.1745