PNN · Class II · 21 CFR 872.5470

FDA Product Code PNN: Orthodontic Software

The Device Is Software That Is To Be Used For The Diagnosis And Treatment Planning Of Orthodontic Patients And Conditions. It May Include Orthodontic Output Devices Used For The Treatment Of Orthodontics. The Device Is Intended For Prescription Use Only.

Leading manufacturers include 3Shape A/S, Software Nemotec S.L. and Laon Medi, Inc..

35
Total
35
Cleared
160d
Avg days
2016
Since
35 devices
25–35 of 35
Cleared Apr 02, 2020
CS Model+
K193390
Trophy
Dental · 118d
Cleared Nov 27, 2019
3Shape Splint Design
K191911
3Shape A/S
Dental · 133d
Cleared Sep 12, 2019
OrthoAnalysis Software
K183695
Inteware Co., Ltd.
Dental · 255d
Cleared Nov 26, 2018
Orchestrate 3D
K181112
Orchestrate 3D
Dental · 213d
Cleared Oct 17, 2018
Ortho System
K180941
3Shape A/S
Dental · 203d
Cleared Jan 17, 2018
Ortho System
K171634
3Shape A/S
Dental · 229d
Cleared Jan 11, 2018
CEREC Ortho Software
K171122
Dentsply Sirona
Dental · 269d
Cleared Jan 09, 2018
ULab Systems Treatment Planning Software
K171295
Ulab Systems, Inc.
Dental · 252d
Cleared Apr 20, 2017
Ortho System
K163677
3Shape A/S
Dental · 114d
Cleared Mar 24, 2017
GuideMia Ortho+
K162850
Guidemia Technologies, LLC
Dental · 164d
Cleared Apr 28, 2016
3Shape Ortho System
K152086
3Shape A/S
Dental · 276d