(1 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description of the proprietary software system does not provide details suggesting the use of such technologies.
Yes
The device is indicated for "alignment of teeth during orthodontic treatment of malocclusion," which clearly describes a therapeutic intervention to correct a medical condition.
No
The device is described as an orthodontic appliance for aligning teeth, which is a treatment modality, not a diagnostic one. Its purpose is to physically move teeth, not to identify or characterize a disease or condition.
No
The device description explicitly states that the system consists of "thin, clear plastic removable orthodontic appliances (aligners)" which are physical hardware components. While software is used for treatment planning and manufacturing, the core medical device is the physical aligner.
Based on the provided information, the Spark™ Clear Aligner System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- The Spark™ Clear Aligner System is a physical appliance used to mechanically move teeth. It directly interacts with the patient's teeth and jaw, rather than analyzing biological samples.
- The intended use is for the alignment of teeth during orthodontic treatment of malocclusion. This is a mechanical and structural treatment, not a diagnostic test based on biological samples.
The description clearly outlines a physical device used for orthodontic treatment, which falls outside the scope of IVD devices.
N/A
Intended Use / Indications for Use
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Product codes
NXC
Device Description
The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal, treated state. Treatment planning, aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligners are held in place by presure and can be removed by the patient at any time. Several treatment options may be integrated into the Spark Clear Aligners, such as cutouts, hooks, and/or other attachment shapes, bite ramps, etc. to aid the aligners with teeth movement. The integrated occlusion guides on the upper and lower aligners allow the option of incrementally repositioning the mandible (lower jaw) forward to address in patients who have not reached full skeletal maturity.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, mandible (lower jaw)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
doctor-prescribed, clinician
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2025
Ormco Corporation % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K250487
Trade/Device Name: SparkTM Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: February 19, 2025 Received: February 19, 2025
Dear Prithul Bom:
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.
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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 (OS) 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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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 medical devices and radiation-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-regulatory
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assistance/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 -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
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Indications for Use
Submission Number (if known)
Device Name
Spark TM Clear Aligner System
Indications for Use (Describe)
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
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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| Declaration of Conformity | ||
|---|---|---|
| Application # | K250487 | |
| Company Name | Ormco Corporation | |
| Company Address | 200 S. Kraemer Blvd. Brea CA 92821 United States | |
| Device Trade Name | Spark™ Clear Aligner System | |
| The subject device(s) is in conformity with the requirements of the following documents: | ||
| Organization | Designation Number and Edition/Date | Recognition # |
| ANSI AAMI ISO | 10993-1: 2018 | 2-258 |
| ANSI AAMI ISO | 10993-5:2009/(R)2014 | 2-245 |
| ANSI AAMI ISO | 10993-10:2010/(R)2014 | 2-174 |
| ANSI AAMI ISO | 10993-11: 2017 | 2-255 |
| ISO | 7405 Third edition 2018-10 Corrected version 2018-12 | 4-261 |
| ASTM | F1980-21 | 14-575 |
| ANSI ADA | Standard No. 41-2020 | 4-295 |
| ANSI AAMI ISO | 14971: 2019 | 5-125 |
| ANSI AAMI ISO | 0 | 2-228 |
Additional Information (e.g., limitations on the validity of the Declaration of Conformity)
Signed for and on behalf of the applicant company:
| Place and Issuance Date: | Brea, CA |
|---|---|
| -------------------------- | ---------- |
2/06/2025
Full Name and Title:
Jessica Pomares; Regulatory Affairs Specialist
Signature
Image /page/4/Picture/9 description: The image shows the name "Jessica Pomares" written in a cursive font. The text is black and the background is white. The font is elegant and decorative.
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510(k) Summary
Prepared on: 2025-02-06
Contact Details
| Applicant Name | Ormco Corporation |
|---|---|
| Applicant Address | 200 S. Kraemer Blvd. Brea CA 92821 United States |
| Applicant Contact Telephone | 714-628-8575 |
| Applicant Contact | Ms. Jessica Pomares |
| Applicant Contact Email | jessica.pomares@envistaco.com |
21 CFR 807.92(a)(1)
Device Name
| Device Trade Name | Spark™ Clear Aligner System |
|---|---|
| Common Name | Orthodontic plastic bracket |
| Classification Name | Aligner, Sequential |
| Regulation Number | 21 CFR part 872.5470 |
| Product Code(s) | NXC |
21 CFR 807.92(a)(2)
Legally Marketed Predicate Devices
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K223517 | Clear Aligner | NXC |
| K240501 | Spark™ Clear Aligner System | NXC |
21 CFR 807.92(a)(3)
Device Description Summary
21 CFR 807.92(a)(4)
The Spark™ Clear Aligner System consists of a series of doctor-prescribed, custom manufactured, thin, clear plastic removable orthodontic appliances (aligners) that gently move the participant's teeth in small increments from their original state to a more optimal,
treated state. Treatment planning, aligner manufacture are supported by a proprietary software system. The clinician receives the aligners and provides them in sequential "stages" to the patient, confirming fit and monitoring treatment from the placement of the first aligner to the removal of the final aligners are held in place by presure and can be removed by the patient at any time. Several treatment options may be integrated into the Spark Clear Aligners, such as cutouts, hooks, and/or other attachment shapes, bite ramps, etc. to aid the aligners with teeth movement. The integrated occlusion guides on the upper and lower aligners allow the option of incrementally repositioning the mandible (lower jaw) forward to address in patients who have not reached full skeletal maturity.
Intended Use/Indications for Use
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Indications for Use Comparison
The Subject Device and Predicate Device share a similar Indications for Use
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)