Cleared Traditional

SOPROLIFE

K092583 · Sopro · Dental
Jan 2010
Decision
145d
Days
Class 2
Risk

About This 510(k) Submission

K092583 is an FDA 510(k) clearance for the SOPROLIFE, a Laser, Fluorescence Caries Detection (Class II — Special Controls, product code NBL), submitted by Sopro (Mt. Laurel, US). The FDA issued a Cleared decision on January 13, 2010, 145 days after receiving the submission on August 21, 2009. This device falls under the Dental review panel. Regulated under 21 CFR 872.1745.

Submission Details

510(k) Number K092583 FDA.gov
FDA Decision Cleared SESE
Date Received August 21, 2009
Decision Date January 13, 2010
Days to Decision 145 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