Cleared Traditional

Ortho System

K161884 · 3Shape A/S · Dental
Apr 2017
Decision
282d
Days
—
Risk

About This 510(k) Submission

K161884 is an FDA 510(k) clearance for the Ortho System, a Mouthguard, Prescription, submitted by 3Shape A/S (Copenhagen K, DK). The FDA issued a Cleared decision on April 19, 2017, 282 days after receiving the submission on July 11, 2016. This device falls under the Dental review panel.

Submission Details

510(k) Number K161884 FDA.gov
FDA Decision Cleared SESE
Date Received July 11, 2016
Decision Date April 19, 2017
Days to Decision 282 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Statement

Device Classification

Product Code MQC — Mouthguard, Prescription
Device Class —