FDA 510(k) Applications for Medical Device Product Code "PNN"
FDA 510(k) Number |
Applicant |
Device Name |
Decision Date |
K152086 |
3Shape A/S |
3Shape Ortho System |
04/28/2016 |
K191911 |
3Shape A/S |
3Shape Splint Design |
11/27/2019 |
K163677 |
3Shape A/S |
Ortho System |
04/20/2017 |
K171634 |
3Shape A/S |
Ortho System |
01/17/2018 |
K180941 |
3Shape A/S |
Ortho System |
10/17/2018 |
K213916 |
ArchForm, Inc |
ArchForm Orthodontic Software System |
12/16/2021 |
K212828 |
BRIUS Technologies Inc |
BRIUS Planner Software |
10/01/2021 |
K212173 |
CDB Corporation |
HDH Treatment Planning System |
01/25/2022 |
K201036 |
Choice Biotech Inc. |
PlaniMax Orthodontic Software |
12/22/2020 |
K171122 |
Dentsply Sirona |
CEREC Ortho Software |
01/11/2018 |
K192847 |
Diorco Co., Ltd. |
AUTOLIGN |
07/21/2020 |
K162850 |
GUIDEMIA TECHNOLOGIES, LLC |
GuideMia Ortho+ |
03/24/2017 |
K183695 |
Inteware Co., Ltd. |
OrthoAnalysis Software |
09/12/2019 |
K191720 |
Mechanodontics, Inc. |
BRUIS Software Suite |
04/17/2020 |
K181112 |
Orchestrate 3D |
Orchestrate 3D |
11/26/2018 |
K192701 |
OrthoSelect, LLC |
DIBS (Digital Indirect Bonding System) |
04/21/2020 |
K223518 |
Shanghai EA Medical Instruments Co., Ltd. |
iOrtho |
06/13/2023 |
K212770 |
SoftSmile, Inc. |
Vision |
12/21/2021 |
K193003 |
Software Nemotec S.L. |
NemoCast |
06/05/2020 |
K203442 |
Swift Health Systems, Inc. |
Inbrace Orthodontic System |
02/19/2021 |
K193390 |
Trophy |
CS Model+ |
04/02/2020 |
K171295 |
ULab Systems, Inc. |
ULab Systems Treatment Planning Software |
01/09/2018 |
K200772 |
ULab Systems, Inc. |
ULab Systems uDesign Software |
06/23/2020 |
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