SOPROLIFE

Laser, Fluorescence Caries Detection

SOPRO

The following data is part of a premarket notification filed by Sopro with the FDA for Soprolife.

Pre-market Notification Details

• Device ID: K092583
• 510k Number: K092583
• Device Name: SOPROLIFE
• Classification: Laser, Fluorescence Caries Detection
• Applicant: SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054
• Contact: Rick Rosati
• Correspondent: Rick Rosati; SOPRO 124 GAITHER DRIVE SUITE 140 Mt. Laurel, NJ 08054
• Product Code: NBL
• CFR Regulation Number: 872.1745 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-08-21
• Decision Date: 2010-01-13
• Summary: summary