Cleared Traditional

K161884 - Ortho System (FDA 510(k) Clearance)

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

K161884 is an FDA 510(k) clearance for the Ortho System. This device is classified as a Mouthguard, Prescription.

Submitted by 3Shape A/S (Copenhagen, 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 FDA review panel.

Submission Details

510(k) Number K161884 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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 -