(197 days)
No
The summary describes a software system for orthodontic diagnosis and treatment simulation that relies on user input and analysis of 3D scans. There is no mention of AI, ML, or any related technologies in the device description, intended use, or performance studies. The software verification and validation testing is based on standard software guidance, not specific AI/ML validation protocols.
No
The device is a treatment planning system that creates virtual designs for orthodontic devices, but it does not directly apply therapy to a patient.
Yes
The "Device Description" explicitly states, "The HDH Treatment Planning system is a software system for orthodontic diagnosis and treatment simulation utilized by dental professionals." The "Intended Use / Indications for Use" also mentions "systematic inspection, detailed analysis" of 3D models of the patient's dentition. These phrases indicate its role in identifying or characterizing a disease or condition.
Yes
The device description explicitly states it is a "software system" and its output is digital files (STL, OBJ) for fabrication, implying the device itself is solely the software for planning and simulation, not the fabrication hardware.
Based on the provided information, the HDH Treatment Planning System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- HDH Treatment Planning System's Function: The HDH Treatment Planning System works with 3D digital scans of the patient's dentition. It provides tools for analysis, simulation, and virtual design based on these scans. It does not involve the examination of specimens taken from the body.
- Intended Use: The intended use clearly states it's for managing orthodontic models, inspection, analysis, treatment simulation, and virtual design of dental casts. This is a planning and design tool, not a diagnostic test performed on biological samples.
The device is a software system used by dental professionals for orthodontic treatment planning, which falls under the category of medical devices, but not specifically In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The HDH Treatment Planning System 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
Product codes (comma separated list FDA assigned to the subject device)
PNN, LLZ
Device Description
The HDH Treatment Planning system is a software system for orthodontic diagnosis and treatment simulation utilized by dental professionals. The software imports patient 3D digital scans serving as a base for diagnosing the orthodontic treatment needs, analyzing, inspecting, measuring, and simulating tooth movements, and allows the user to develop a virtual treatment plan. The output of the treatment plan may be downloaded as files in STL format, a standard stereolithographic file format, or OBJ format, a standard 3D image format, for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
3D models are generated from scanned analog impressions or directly from an intra-oral scan.
Anatomical Site
patient's dentition / patient's teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
dental professionals / practice of orthodontics
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005).
All test results met acceptance criteria, demonstrating the HDH Treatment Planning System performs as intended and is substantially equivalent to the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
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.(b)
Classification. Class II.
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January 25, 2022
CDB Corporation Leah Lehman Senior Operations Manager 9201 Industrial Boulevard, NE Leland, North Carolina 28451
Re: K212173
Trade/Device Name: HDH Treatment Planning System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: PNN, LLZ Dated: December 29, 2021 Received: January 4, 2022
Dear Leah Lehman:
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 (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 located 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.
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
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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 803) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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).
Sincerely,
Michael E. Adjodha, M.ChE. 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
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Indications for Use
510(k) Number (if known) K212173
Device Name HDH Treatment Planning System
Indications for Use (Describe)
The HDH Treatment Planning System 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the necessary training and domain knowledge in the practice of orthodontics, as well 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) |
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Image /page/3/Picture/2 description: The image shows the logo for CDB Ceramic Dental Brackets, followed by the text "510(k) Summary" in a large, bold font. The logo consists of a stylized blue shape resembling a stylized letter "E" or a series of overlapping triangles. The text "CDB" is in a sans-serif font, with the words "CERAMIC DENTAL BRACKETS" written in a smaller font size below it.
This 510(k) Summary is submitted in accordance with the requirements of 21CFR 807.92
- Submitter: CDB Corporation 9201 Industrial Blvd, NE Leland, NC 28451 USA Owner/Operator No.: 9002860 Establishment Registration No.: 1054415 Primary Contact: Leah M Lehman Senior Operations Manager Phone: 910.383.6464 llehman@cdbcorp.net Secondary Contact: Herbert Haas Managing Director Phone: 910.383.6464 hhaas@cdbcorp.net
| Date Prepared: | January 12, 2022 |
|---|---|
| 510k Submission: | K212173 |
| Device Name: | HDH Treatment Planning System |
| CFR Classification: | 21 CRF 872.5470 |
| Device Classification Name: | Orthodontic Plastic Bracket |
| Product Code: | PNN (Orthodontic Software), |
| LLZ (System, image processing, radiological) | |
| Common Name: | Orthodontic Treatment Planning & Diagnosis Software |
| Classification: | Medical Device, Class II |
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Indications for Use:
The HDH Treatment Planning System 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 design of a series of dental casts, which may be used for sequential aligner trays or retainers, based on 3D models of the patient's dentition. The use of the HDH Treatment Planning System requires the user to have the necessary training and domain knowledge in the practice of orthodontics, as well to have received a dedicated training in the use of the software.
Predicate Device:
3Shape Ortho System, 3Shape A/S, K152086 (primary predicate) HIT Clear Aligner, CDB Corporation, K210613 (reference device)
Device Description:
The HDH Treatment Planning system is a software system for orthodontic diagnosis and treatment simulation utilized by dental professionals. The software imports patient 3D digital scans serving as a base for diagnosing the orthodontic treatment needs, analyzing, inspecting, measuring, and simulating tooth movements, and allows the user to develop a virtual treatment plan. The output of the treatment plan may be downloaded as files in STL format, a standard stereolithographic file format, or OBJ format, a standard 3D image format, for fabrication of dental casts, which may be used to fabricate sequential aligner trays or retainers.
Technological characteristics:
The HDH Treatment Planning system is a software device programmed in C++ with the following hardware requirements:
| Item | Minimum Requirements |
|---|---|
| OS: | Windows 8 or 10, 64 bit |
| RAM: | >=8 GB |
| Monitor Resolution: | 1280x800 |
| Video Card Memory: | >=1GB |
| Available HDD Space: | 10 GB |
| CPU: | Intel core i5 2500 or equivalent |
| Network: | Network Internet connection |
| Mouse: | With the wheel button |
The above hardware requirements are found to be substantially equivalent to the requirements of 3Shape Ortho System ™, FDA cleared per K152086.
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Performance Data:
Software verification and validation testing was performed in accordance with the FDA Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (issued May 11, 2005).
All test results met acceptance criteria, demonstrating the HDH Treatment Planning System performs as intended and is substantially equivalent to the predicate devices.
Substantial Equivalence Discussion:
The following table compares the HDH Treatment Planning System to the predicate device, 3Shape Ortho System ™, with respect to indications for use, technological characteristics, and principles of operation. The reference device, HIT Clear Aligner, is also presented in the comparison table.
| Feature | HDH Treatment
Planning System
Submission Device | 3Shape Ortho System™
Predicate Device | HIT Clear Aligner
Reference Device |
|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K212173 | K152086 | K210613 |
| Manufacturer | CDB Corporation | 3Shape A/S | CDB Corporation |
| Regulation
Number | 872.5470 | 872.5470 | 872.5470 |
| Device
Classification
Name | Orthodontic Plastic
Bracket | Orthodontic Plastic Bracket | Orthodontic Plastic
Bracket |
| Product Code | PNN (Orthodontic
Software)
LLZ (System, image
processing, radiological) | PNN (Orthodontic Software)
LLZ (System, image
processing, radiological) | NXC
(Aligner, Sequential) |
| Common Name | Orthodontic Treatment
Planning and Diagnosis
Software | Orthodontic Treatment
Planning and Diagnosis
Software | Aligner, Sequential |
| Device Class | II | II | II |
| Indications for
Use | The HDH Treatment
Planning System 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 design of a series
of dental casts, which
may be used for | 3Shape Ortho System™ 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
(Custom Metal Bands,
Export of Models, Indirect
Bonding Transfer Media) | The HIT Clear
Aligner system is
indicated for the
treatment of
malocclusion in
patients with
permanent dentition.
The HIT Clear
Aligner system
positions teeth by
way of continuous
gentle force. |
| | sequential aligner trays or
retainers, based on 3D
models of the patient's
dentition. The use of the
HDH Treatment Planning
System requires the user
to have the necessary
training and domain
knowledge in the practice
of orthodontics, as well to
have received a
dedicated training in the
use of the software. | based on 3D models 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 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. | |
| Operating
principle | The software provides
calculation displaying the
recommended sequential
aligners staging on the
patient's teeth, based on
the pre-treatment 3D
scanned orthodontic
model, clinician-
prescribed treatment
objective and clinician's
general pre-treatment
preferences. | The software provides
calculation displaying virtual
appliance design options
based on 3D models of a
patient's dentition. | Alignment of teeth
by sequential use of
preformed plastic
trays. |
| Key records | 3D models are generated
from scanned analog
impressions or directly
from an intra-oral scan. | 3D scanned orthodontic
models | From the software
part: 3D models are
generated from
scanned analog
impressions or
directly from an
intra-oral scan. |
| Software end
product | Dental casts | Custom metal bands,
indirect bonding transfer
trays and
dental casts | Dental casts |
| Application of
digital imaging
tools based on
3D orthodontic
models for
orthodontic case
archiving,
diagnosis,
treatment
planning and
CAD design | Yes | Yes | Yes |
| Virtual planning
of orthodontic
treatments
simulating tooth
movements | Yes | Yes | Yes |
| Supported types
of digital data | STL, OBJ | DICOM, STL, JPG, BMP,
PNG | STL, OBJ |
| OTC or Rx | Rx | Rx | Rx |
Table 1. Predicate Device Information Comparison
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The software output for the predicate device is represented by custom metal bands, indirect bonding transfer trays and dental casts, whereas the subject device designs only dental casts.
Clinical Testing:
Clinical testing is not a requirement and has not been performed.
Substantial Equivalence Conclusion:
By definition, a device is substantially equivalent when the device has the same intended use and the same technological characteristics as the predicate device. The subject and the primary predicate devices share intended use including software used by dental professionals in orthodontic treatment planning for management of patients and orthodontic models, inspection, measurement and analysis of the models, treatment simulation, preparation and export of a series of virtual dental casts. The subject and the primary predicate devices share the same operating principle.
The software output for the predicate device is represented by custom metal bands, indirect bonding transfer trays and dental casts, whereas the subject device designs only dental casts. The difference in the software output along with the supported types of digital data is insignificant and do not require further testing to ensure the correct product operation; thus, the difference does not affect safety or efficacy of the subject device.
The subject and predicate devices share digital imaging tools based on 3D orthodontic models for orthodontic case archiving, diagnosis, treatment planning and CAD design, and virtual planning of orthodontic treatments simulating tooth movements.
Performance data demonstrates that any differences in technological characteristics do not raise different questions of safety or effectiveness.
The conclusion drawn from the data included in this submission demonstrates that the HDH Treatment Planning system is substantially equivalent to the cleared predicate device.