PNN · Orthodontic Software · Chrysalis Intelligence

Device class

Class II

Regulation 872.5470

Total clearances

2020-04-02 → 2026-05-08

Last 12 months

Unique sponsors

Definition

What is 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.

Classification details

Medical specialty

Dental

Review panel

Regulation number

872.5470

Implant

Life-sustain / support

GMP exempt

Third-party review

Trend

Clearance volume by quarter

Players

Top sponsors in this product code

Sponsor	Clearances	Last 12 mo	Most recent
Laon Medi, Inc.	2	0	2025-04-23
Software Nemotec S.L.	2	0	2023-11-21
Softsmile, Inc.	1	0	2021-12-21
Swift Health Systems, Inc.	1	0	2021-02-19
Choice Biotech, Inc.	1	0	2020-12-22
Dentsply Sirona, Inc.	1	1	2026-03-04
Progressive Aligners, Inc.	1	0	2024-10-11
Clevaligner, Ltd.	1	0	2024-01-11
Ulab Systems, Inc.	1	0	2020-06-23
Shanghai EA Medical Instruments Co., Ltd.	1	0	2023-06-13
Brius Technologies, Inc.	1	0	2021-10-01
Trophy	1	0	2020-04-02
Hangzhou ChohoTech Co., Ltd.	1	1	2026-05-08
Ray Co., Ltd.	1	0	2024-05-16
Cdb Corporation	1	0	2022-01-25
Orthoselect, LLC	1	0	2020-04-21
Diorco Co., Ltd.	1	0	2020-07-21
Celebrace	1	1	2025-12-29
Clearadvance, LLC	1	0	2023-10-13
Amv Consulting, LLC	1	1	2026-01-07
Mechanodontics, Inc.	1	0	2020-04-17
Archform, Inc.	1	0	2021-12-16

Reimbursement

Likely billing codes (AI-inferred · verify with billing)

Healthcare providers using this device would typically bill under these HCPCS Level II (alphanumeric) or CPT (5-digit) codes. Mapping inferred from device function by Claude Haiku; official descriptions pulled from the CMS HCPCS April 2026 quarterly file where available. Always verify with billing/coding teams before relying on these.

Code	Type	Description	Confidence	Rationale
21085	CPT	—	Medium	Orthodontic treatment planning and diagnosis via software; adjunctive to orthodontic procedures
D8080	HCPCS	—	Low	Dental-specific orthodontic software codes; mapping uncertain, may not have dedicated billing code

Pulse

Most recent 510(k) clearances

Date	K-number	Sponsor	Device
2026-05-08	K260419	Hangzhou ChohoTech Co., Ltd.	LingOral Dental Design System
2026-03-04	K253565	Dentsply Sirona, Inc.	SureSmile Software
2026-01-07	K252507	Amv Consulting, LLC	SmileInspector
2025-12-29	K253343	Celebrace	Celebrace Software
2025-04-23	K250198	Laon Medi, Inc.	Laon Ortho
2024-10-11	K241153	Progressive Aligners, Inc.	Progressive Orthodontics App
2024-05-16	K233625	Ray Co., Ltd.	RAYDENT SW
2024-03-12	K232564	Laon Medi, Inc.	Align Studio
2024-01-11	K233616	Clevaligner, Ltd.	Clevaligner Software (V1.0.0)
2023-11-21	K232549	Software Nemotec S.L.	NemoCast
2023-10-13	K232429	Clearadvance, LLC	Titan Dental Design
2023-06-13	K223518	Shanghai EA Medical Instruments Co., Ltd.	iOrtho
2022-01-25	K212173	Cdb Corporation	HDH Treatment Planning System
2021-12-21	K212770	Softsmile, Inc.	Vision
2021-12-16	K213916	Archform, Inc.	ArchForm Orthodontic Software System
2021-10-01	K212828	Brius Technologies, Inc.	BRIUS Planner Software
2021-02-19	K203442	Swift Health Systems, Inc.	Inbrace Orthodontic System
2020-12-22	K201036	Choice Biotech, Inc.	PlaniMax Orthodontic Software
2020-07-21	K192847	Diorco Co., Ltd.	AUTOLIGN
2020-06-23	K200772	Ulab Systems, Inc.	ULab Systems uDesign Software
2020-06-05	K193003	Software Nemotec S.L.	NemoCast
2020-04-21	K192701	Orthoselect, LLC	DIBS (Digital Indirect Bonding System)
2020-04-17	K191720	Mechanodontics, Inc.	BRUIS Software Suite
2020-04-02	K193390	Trophy	CS Model+