Cleared Traditional

DIAGNODENT PERIO TIP (ACCESSORY)

K042394 · Kavo America Corporation · Dental
Aug 2005
Decision
334d
Days
Class 2
Risk

About This 510(k) Submission

K042394 is an FDA 510(k) clearance for the DIAGNODENT PERIO TIP (ACCESSORY), a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Kavo America Corporation (Deer Field, US). The FDA issued a Cleared decision on August 2, 2005, 334 days after receiving the submission on September 2, 2004. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K042394 FDA.gov
FDA Decision Cleared SESE
Date Received September 02, 2004
Decision Date August 02, 2005
Days to Decision 334 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