Atlas FDA

PNN

34 FDA 510(k) clearances · Product code

168 daysmedian time to decision
269 days90th percentile
34clearances measured

FDA profile

Official device name
Orthodontic Software
Device class
Class II (moderate risk)
Regulation
21 CFR 872.5470
Medical specialty
Dental
Flags
Third-party review eligible
FDA definition
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.
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RecordFirmDate
LingOral Dental Design System (K260419)Hangzhou ChohoTech Co., Ltd.2026-05-08
SureSmile Software (K253565)Dentsply Sirona, Inc.2026-03-04
SmileInspector (K252507)Amv Consulting, LLC2026-01-07
Celebrace Software (K253343)Celebrace2025-12-29
Laon Ortho (K250198)Laon Medi, Inc.2025-04-23
Progressive Orthodontics App (K241153)Progressive Aligners, Inc.2024-10-11
RAYDENT SW (K233625)Ray Co., Ltd.2024-05-16
Align Studio (K232564)Laon Medi, Inc.2024-03-12
Clevaligner Software (V1.0.0) (K233616)Clevaligner, Ltd.2024-01-11
NemoCast (K232549)Software Nemotec S.L.2023-11-21
Titan Dental Design (K232429)Clearadvance, LLC2023-10-13
iOrtho (K223518)Shanghai EA Medical Instruments Co., Ltd.2023-06-13
HDH Treatment Planning System (K212173)Cdb Corporation2022-01-25
Vision (K212770)Softsmile, Inc.2021-12-21
ArchForm Orthodontic Software System (K213916)Archform, Inc.2021-12-16
BRIUS Planner Software (K212828)Brius Technologies, Inc.2021-10-01
Inbrace Orthodontic System (K203442)Swift Health Systems, Inc.2021-02-19
PlaniMax Orthodontic Software (K201036)Choice Biotech, Inc.2020-12-22
AUTOLIGN (K192847)Diorco Co., Ltd.2020-07-21
ULab Systems uDesign Software (K200772)Ulab Systems, Inc.2020-06-23
NemoCast (K193003)Software Nemotec S.L.2020-06-05
DIBS (Digital Indirect Bonding System) (K192701)Orthoselect, LLC2020-04-21
BRUIS Software Suite (K191720)Mechanodontics, Inc.2020-04-17
CS Model+ (K193390)Trophy2020-04-02
3Shape Splint Design (K191911)3Shape A/S2019-11-27
OrthoAnalysis Software (K183695)Inteware Co., Ltd.2019-09-12
Orchestrate 3D (K181112)Orchestrate 3D2018-11-26
Ortho System (K180941)3Shape A/S2018-10-17
Ortho System (K171634)3Shape A/S2018-01-17
CEREC Ortho Software (K171122)Dentsply Sirona2018-01-11
ULab Systems Treatment Planning Software (K171295)Ulab Systems, Inc.2018-01-09
Ortho System (K163677)3Shape A/S2017-04-20
GuideMia Ortho+ (K162850)Guidemia Technologies, LLC2017-03-24
3Shape Ortho System (K152086)3Shape A/S2016-04-28

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