Cleared Traditional

SEE-IT CARIES DETECTOR

K060330 · Ronvig Dental Mfg. A/S · Dental

Apr 2006

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K060330 is an FDA 510(k) clearance for the SEE-IT CARIES DETECTOR, a Device, Caries Detection (Class II — Special Controls, product code LFC), submitted by Ronvig Dental Mfg. A/S (Daugaard, DK). The FDA issued a Cleared decision on April 7, 2006, 57 days after receiving the submission on February 9, 2006. This device falls under the Dental review panel. Regulated under 21 CFR 872.1740.

Submission Details

510(k) Number	K060330 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 09, 2006
Decision Date	April 07, 2006
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Statement