Cleared Traditional

SPECTRA FLUORESCENCE CARIES DETECTION DEVICE

K090169 · Air Techniques, Inc. · Dental
Aug 2009
Decision
207d
Days
Class 2
Risk

About This 510(k) Submission

K090169 is an FDA 510(k) clearance for the SPECTRA FLUORESCENCE CARIES DETECTION DEVICE, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Air Techniques, Inc. (Great Neck, US). The FDA issued a Cleared decision on August 18, 2009, 207 days after receiving the submission on January 23, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K090169 FDA.gov
FDA Decision Cleared SESE
Date Received January 23, 2009
Decision Date August 18, 2009
Days to Decision 207 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