Who is the manufacturer of Align Studio?

Laon Medi, Inc. filed the 510(k) submission for Align Studio (K232564).

What is the FDA product code for Align Studio?

PNN. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Align Studio?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Align Studio?

Ortho System (K180941); CEREC Ortho Software (K171122).

Who can help prepare an FDA 510(k) submission like Align Studio?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Align Studio

K232564 · Laon Medi, Inc. · PNN · Mar 12, 2024 · Dental

Device Facts

Record ID	K232564
Device Name	Align Studio
Applicant	Laon Medi, Inc.
Product Code	PNN · Dental
Decision Date	Mar 12, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Software as a Medical Device

Intended Use

The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Align Studio requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software.

Device Story

Align Studio is PC-based software for orthodontic treatment planning; inputs include 3D digital impressions (STL files) and DICOM CT image data. Software automatically segments crown and gum tissue; provides tools for model analysis, systematic inspection, treatment simulation, and virtual appliance design (e.g., indirect bonding transfer media). Used by orthodontists in clinical settings to assist in diagnosis, treatment planning, and CAD design. Output includes 3D virtual models and simulation data; aids clinicians in visualizing tooth movement and evaluating treatment progress or final outcomes. Benefits include improved workflow for digital orthodontic procedures and enhanced precision in treatment planning.

Clinical Evidence

No clinical studies were performed. Substantial equivalence is supported by bench testing, including software verification and validation, and performance testing confirming the device meets all functional criteria.

Technological Characteristics

PC-based standalone software. Inputs: STL surface scans, DICOM CT data. Functions: 3D model segmentation (crown/gum), measurement, treatment simulation, and CAD design. Software development follows standard processes; validated per FDA guidance for Device Software Functions. No hardware components.

Indications for Use

Indicated for orthodontic patients requiring management of orthodontic models, systematic inspection, detailed analysis, treatment simulation, and virtual appliance design based on 3D dentition models. Used before, during, and after orthodontic treatment to evaluate progress and outcomes. Requires trained orthodontic professionals.

Regulatory Classification

Identification

An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.

Predicate Devices

Ortho System (K180941)
CEREC Ortho Software (K171122)

Related Devices

K250198 — Laon Ortho · Laon Medi, Inc. · Apr 23, 2025
K223518 — iOrtho · Shanghai EA Medical Instruments Co., Ltd. · Jun 13, 2023
K253565 — SureSmile Software · Dentsply Sirona, Inc. · Mar 4, 2026
K171634 — Ortho System · 3Shape A/S · Jan 17, 2018
K152086 — 3Shape Ortho System · 3Shape A/S · Apr 28, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. March 12, 2024 Laon Medi Inc. Mina Yun Quality Management Representative 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu Seongnam-si, Gyeonggi-do 13511 SOUTH KOREA Re: K232564 Trade/Device Name: Align Studio Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: January 12, 2024 Received: January 12, 2024 Dear Mina Yun: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2}------------------------------------------------ Sincerely, # Michael E. Adjodha -S Michael E. Adjodha, MChE, RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K232564 Device Name Align Studio Indications for Use (Describe) The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. The use of the Align Studio requres the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------------------------------------------| | ☑ Prescription Use (Part 21 CFR 801 Subpart D) | | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the logo for LAON iMEDI. The text is in a sans-serif font, with the letters "LAON" and "MEDI" in green. The "i" in "iMEDI" is orange. The logo is simple and modern. 404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongna +82 31 8017 7145 | qna@laon-medi.com | laon-medi.com # K232564 # 510(k) Summary [As required by 21 CFR 807.92] #### Date Prepared [21 CFR 807.92(a)(a)] 1. August 24, 2023 #### Submitter's Information & Contact Person [21 CFR 807.92(a)(1)] 2. - Name of Manufacturer: LAON MEDI Inc. - Address: 404, Bundang Techno Park B, 723, Pangyo-ro, Bundang-gu, Seongnam-si, Gyeonggido, 13511 Republic of Korea / Tel: 031-8017-7145 - Contact Name: Mina Yun - Telephone No.: +82 10 3953 4808 - Fax No.: +82 31 701 8863 - may@laon-medi.com - Email Address: #### 3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)] Trade name: Align Studio | Classification Description | 21 CFR Section | Product Code | |----------------------------------------|----------------|--------------| | Orthodontic Software | 872.5470 | PNN | | System, Image Processing, Radiological | 892.2050 | LLZ | As stated in 21 CFR, parts 872.5470 and 892.2050, this generic types of devices has been classified as Class II. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in green, followed by "iMEDI" also in green, but with a small orange square above the "i". The logo is simple and modern, with a focus on the company name. 404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, C +82 31 8017 7145 | qna@laon-medi.com | laon-medi.com #### 4. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)] The identified predicate devices within this submission are shown as follow: Predicate device #1 - 510(k) Number: K180941 - . 3Shape A/S Applicant: - Classification Name: Orthodontic Software - Trade Name: Ortho System ### Predicate device #2 - 510(k) Number: K171122 - Applicant: Dentsply Sirona - Classification Name: ● Orthodontic Software - Trade Name: CEREC Ortho Software ● #### ട. Description of the Device [21 CFR 807.92(a)(4)] Align Studio is a PC-based software that sets up virtual orthodontics via digital impressions. It automatically segments the crown and the gum in a simple manner and provides basic model analysis to assist digital orthodontic procedures. #### Indications for Use [21 CFR 807.92(a)(5)] 6. The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Align Studio requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the logo for LAON iMEDI. The text "LAON" is in large, green, sans-serif font. To the left of the "M" in "MEDI" is a small orange square. The rest of the text, "MEDI", is in the same green font as "LAON". 404, Bundang Techno Park B, 723, Pangyo-ro (Yatap-dong), Bundang-gu, Seongnam-si, Gyeonggi-do, 13511 Korea +82 31 8017 7145 | qna@laon-medi.com | laon-medi.com #### 7. Determination of Substantial Equivalence [21 CFR 807.92(a)(6) and 21 CFR 807.92(b)] There are no significant differences between Align Studio and the predicate devices that would adversely affect the use of the product. It is substantially equivalent to this device in design, function, and technical characteristics. | | Proposed Device | Predicate Device #1 | Predicate Device #2 | SE Decision | |-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------| | K Number | - | K180941 | K171122 | - | | Manufacturer | LAON MEDI Inc. | 3Shape A/S | Dentsply Sirona | - | | Model | Align Studio | Ortho System | CEREC Ortho Software | - | | Intended Use | The Align Studio is intended for use as a medical front-end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options (Export of Models, Indirect Bonding Transfer Media) based on 3Dmodels of the patient's dentition before the start of an orthodontic treatment. It can also be applied during the treatment to inspect and analyze the progress of the treatment. It can be used at the end of the treatment to evaluate if the outcome is consistent with the planned/desired treatment objectives. The use of the Align Studio requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. | Ortho System™ for dental retainers and dental cast for sequential aligners is intended for use as a medical front- end device providing tools for management of orthodontic models, systematic inspection, detailed analysis, treatment simulation and virtual appliance design options based on 3D models of the patient's dentition before the start of an orthodontic treatment. The use of the Ortho System™ requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well as to have received a dedicated training in the use of the software. | CEREC Ortho Software is intended for use with image data acquired from handheld intra oral 3D cameras and desktop laboratory scanners to create 3D virtual models to be used for data acquisition and modeling analysis for orthodontic patients and conditions. The CEREC Ortho Software 3D model data can be exported to orthodontic design software to aid in the design of orthodontic appliances. | Same | | Module | Imports scanned image of patient | Imports scanned image of patient | Imports scanned image of patient | Same | | | Stand-alone software module | Stand-alone software module | Stand-alone software module | | | | Can be used to design dental casts | Can be used to design dental casts | Can be used to design dental casts | | | | Useful for diagnosis, treatment planning, and CAD design | Useful for diagnosis, treatment planning, and CAD design | Useful for diagnosis, treatment planning, and CAD design | | | | Virtual planning of tooth movement | Virtual planning of tooth movement | Virtual planning of tooth movement | Same | | | Supports .stl files | Supports .stl files | Supports .stl files | | | Managing patient and case base data | Creating, editing, deleting and copying patient data | Creating, editing, deleting and copying patient data | Creating, editing, deleting and copying patient data | Same | | | Creating, editing, deleting and copying case data | Creating, editing, deleting and copying case data | Creating, editing, deleting and copying case data | | | Collection of study material | - | Surface scan for intra- oral scanner | Surface scan for intra- oral scanner | Same | | | Surface scan from STL file | Surface scan from STL file | Surface scan from STL file | | | | CT image data(DICOM) | CT image data(DICOM) | - | | | | - | 2D overlay(PNG, JPG, BMP) | - | | | | Creation of virtual 3D virtual dental models | Creation of virtual 3D virtual dental models | Creation of virtual 3D virtual dental models | | | Alignment of study material | Aligning surface scan or CT image | Aligning surface scan or CT image | Creation of virtual 3D virtual dental models | Same | | | Aligning cephalometric images | Aligning cephalometric images | - | | | | - | Alignment of 2D overlays | - | | | | Ability to check/adjust DICOM visibility | Ability to check/adjust DICOM visibility | | | | Measuring study material | - | 2D measurement toolbox | - | Same | | | 3D measurement toolbox | 3D measurement toolbox | 3D measurement toolbox | | | | Definition of dental Arch shape & length | Definition of dental Arch shape & length | - | | | Analyzing study material | - | Wire length | Wire length | | | | Tooth width measurements | Tooth width measurements | - | | | | Tooth and gingiva separation/segmentation | - | Tooth and gingiva separation/segmentation | Same | | | Bolton's analysis | Bolton's analysis | Bolton's analysis | | | | Space analysis | Space analysis | Space analysis | | | | Overjet/overbite | Overjet/overbite | - | | | | Occlusal mapping | Occlusal mapping…