FDA 510(k) Applications for Medical Device Product Code: PNN ()

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
K232429	ClearAdvance, LLC	Titan Dental Design	10/13/2023
K233616	Clevaligner Ltd	Clevaligner Software (V1.0.0)	01/11/2024
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
K232564	Laon Medi Inc.	Align Studio	03/12/2024
K250198	LAON MEDI Inc.	Laon Ortho	04/23/2025
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
K241153	Progressive Aligners Inc.	Progressive Orthodontics App	10/11/2024
K233625	RAY Co., Ltd.	RAYDENT SW	05/16/2024
K223518	Shanghai EA Medical Instruments Co., Ltd.	iOrtho	06/13/2023
K212770	SoftSmile, Inc.	Vision	12/21/2021
K232549	Software Nemotec S.L.	NemoCast	11/21/2023
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