Cleared Traditional

ORTHOPHOS SL

K150217 · Sirona Dental Systems GmbH · Radiology
May 2015
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K150217 is an FDA 510(k) clearance for the ORTHOPHOS SL, a X-ray, Tomography, Computed, Dental (Class II — Special Controls, product code OAS), submitted by Sirona Dental Systems GmbH (Bensheim, DE). The FDA issued a Cleared decision on May 8, 2015, 98 days after receiving the submission on January 30, 2015. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1750.

Submission Details

510(k) Number K150217 FDA.gov
FDA Decision Cleared SESE
Date Received January 30, 2015
Decision Date May 08, 2015
Days to Decision 98 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF

Device Classification

Product Code OAS — X-ray, Tomography, Computed, Dental
Device Class Class II — Special Controls
CFR Regulation 21 CFR 892.1750
Definition Produce Cross-sectional Diagnostic X-ray Images Of The Intra-oral Tissue And Teeth.