(6 days)
No
The summary describes a software system for treatment planning, design, and fabrication of aligners, but it does not mention the use of AI or ML algorithms for any of these processes. The comparison to the predicate device and performance studies focus on material properties and clinical efficacy, not on the underlying software intelligence.
Yes
The device is indicated for "alignment of teeth during orthodontic treatment of malocclusion," which involves treating a disease or condition (malocclusion) to improve health and function.
No
The device is an orthodontic treatment system that aligns teeth; it does not diagnose a medical condition.
No
The device description clearly states that the system consists of "custom manufactured, clear plastic removable orthodontic appliances (aligners)" which are physical hardware components. While software is used for design and fabrication, the final medical device delivered to the patient is a physical aligner.
Based on the provided information, the Ormco™ Spark™ Aligner System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the alignment of teeth during orthodontic treatment of malocclusion. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a series of physical aligners that apply force to move teeth. While software is used in the design and manufacturing process, the core function is mechanical tooth movement.
- No mention of analyzing biological samples: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not interact with or analyze such samples.
The device is clearly a medical device used for treatment, not for providing diagnostic information based on in vitro analysis.
N/A
Intended Use / Indications for Use
The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.
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 aligner. The trays are held in place by pressure and can be removed by the patient at any time.
Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment. These treatment options are available in both the Ormco™ Spark™ Aligner as well as the Predicate Invisalign Aligner (please see Table 5.1).
Ormco also intends to trademark the Ormco Spark Aligner System as: Ormco Kappa Aligner System, Ormco Clear Aligner System, and Ormco Spark Clear Aligner System.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
dental scans
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars)
Intended User / Care Setting
Dental Professionals
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)
Performance Testing: The performance data compares the software, design, treatment characteristics and treatment process of the Spark Aligner to the predicate Invisalign Aligner. The stress relaxation, flexural and tensile strength were compared to the commercially-available Zendura Aligner material, as well as Invisalign's SmartTrack Aligner material. Comparison of mechanical testing of Spark Aligner material (TruGEN) and Invisalign Aligner material (SmarkTrack) indicates the substantial equivalence of their technological characteristics. Bench testing of aligners was not performed due to the difficulty of evaluating these device types in a laboratory; however, translucency, staining, shelf life and shipping tests were carried on the thermoformed TruGENTM material which showed acceptable properties for all tested samples. Additionally, several aligner features were tested and found to be acceptable including attachment dimensional accuracy, cutout effects on stability, force evaluation of attachments and bite ramp and hook evaluation at specified cycles. Biocompatibility testing performed on both TruGEN material and Spark aligners per ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process included cytotoxicity, sensitization and irritation, and intracutaneous reactivity evaluation. The performance data demonstrates substantial equivalence of the subject Spark Aligner device to the Predicate Invisalign Aligner device. Clinical Performance Data: Clinical performance testing has not been completed for the Ormco™ Spark™ Aligner System. A comprehensive scientific literature review and analysis was conducted by orthodontic specialists on behalf of Ormco (please see Appendix A). Research articles and reports on the predicate device covered various subjects including the efficacy of the aligner on treating different types of orthodontic malocclusions. There is sufficient information available from scientific literature and from the predicate devices to demonstrate that orthodontic, sequential, clear aligners provide reasonable assurance of safety and effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
0
October 11, 2018
Image /page/0/Picture/1 description: The image contains two logos. On the left is the logo for the Department of Health & Human Services, which features a stylized human figure. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Sybron Dental Specialties % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K182826
Trade/Device Name: Ormco Spark Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: October 3, 2018 Received: October 5, 2018
Dear Mark Job:
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
1
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner -S3
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION 4. INDICATIONS FOR USE STATEMENT
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known) K 182826
Device Name
Ormco™ Spark™ Aligner System
Indications for Use (Describe)
The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable)
X 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. "
FORM FDA 3881 (7/17) Publishing Services (301) 443-6740
PSC
3
SECTION 5. 510(k) SUMMARY FOR ORMCO™ SPARK™ ALIGNER SYSTEM
Image /page/3/Picture/1 description: The image shows the logo for Sybron Dental Specialties. The logo features the letters 'sds' in a bold, sans-serif font, with the letters overlapping slightly. The letters are in a dark blue color. Below the letters, the words 'Sybron Dental Specialties' are written in a smaller, sans-serif font, also in dark blue. A curved line extends over the top of the 'sds' letters, adding a dynamic element to the logo.
510(k) SUMMARY for Ormco™ Spark™ Aligner System
In accordance with Title 21 of the Code of Federal Regulations, Part 807, and in particular 21 CFR $807.92, the following summary of information is provided:
-
- Submitter Information:
Sybron Dental Specialties 1717 W. Collins Ave. Orange CA, 92687
- Submitter Information:
Primary Contact: | Mey Saied |
---|---|
Telephone Number: | 909-962-5675 |
Fax Number: | 909-962-5694 |
Alternate Contact: | Valerie Cimmarusti |
---|---|
Telephone Number: | 714-516-7476 |
Fax Number: | 909-962-5694 |
Date Prepared: September 12, 2018
-
- Device Name:
Proprietary Name: | Ormco™ Spark™ Aligner System |
---|---|
Classification Name: | Aligner, Sequential |
Regulation Description: | Aligner, Sequential |
CFR Number: | 872.5470 |
Device Class: | II |
Product Code: | NXC |
-
- Predicate Device:
The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the legally marketed device Invisalign System K143630 cleared on November 18, 2015, product code NXC, by Align Technology.
- Predicate Device:
4
Description of Device: 4.
The Ormco™ Spark™ Aligner System consists of a series of doctor-prescribed, custom manufactured, clear plastic removable orthodontic appliances (aligners) that incrementally move the patient's teeth from an original state to a treated state. Treatment planning, aligner design and aligner manufacture are supported by a proprietary software system. The Ormco™ SparkTM Aligner system consists of multiple interfacing software modules; Web, Design, Approver and Fabrication. The Spark Aligner Web software module is an online portal, where clinicians can create new patient profiles, plan treatments, manage patients and submit prescriptions, photos, images and digital scans to Ormco. Ormco technicians use a reference Anatomy software and the Ormco™ Spark™ Aligner Design software to create a 3D model of the patient's teeth from dental scans and to generate a 3D image of a final, treated state, as well as 3D aligner transitional treatment stage models, and submits them to the clinician. The clinician uses the Approver Software to review and approve the models, then Ormco uses the Fabrication software to produce resin molds for thermoforming the aligners.
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 aligner. The trays are held in place by pressure and can be removed by the patient at any time.
Several treatment options may be integrated into the Ormco Spark/Kappa aligner. Attachments or "buttons" may be prescribed by the dental practitioner to facilitate tooth movement and aligner anchorage. The dental practitioner may choose a standard dental composite and adhesive to bond the attachments to the dentition. The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Hooks may be designed into the aligner, then connected by an elastic to a toothbonded button on the opposite arch. to apply additional forces. Bite ramps are step features built into the lingual surfaces of the upper aligner arch that used by the clinician to prevent movement of the teeth during overbite correction treatment. Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to address voids of missing teeth or other gaps during treatment. These treatment options are available in both the Ormco™ Spark™ Aligner as well as the Predicate Invisalign Aligner (please see Table 5.1).
Ormco also intends to trademark the Ormco Spark Aligner System as: Ormco Kappa Aligner System, Ormco Clear Aligner System, and Ormco Spark Clear Aligner System.
5. Indications for Use:
The Ormco™ Spark™ Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion in patients with permanent dentition (i.e., all second molars). The Ormco™ Spark™ Aligner System positions teeth by way of continuous gentle force.
6. Mode of Action:
The mechanism of action is similar to the predicate devices and supports a determination of substantial equivalence (as defined in 21 U.S.C. § 360c(i)). Orthodontic tooth movement
5
occurs through forces applied by the appliance to the dentition as each tooth follows the programmed displacement based on a dental clinician's prescription.
7. Description of Substantial Equivalence:
The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the predicate device Invisalign (K143630). For purposes relevant to this regulatory filing, and as discussed in the previous subsections, technological characteristics, performance testing and clinical literature review indicate the substantial equivalence of the Ormco™ Spark™ Aligner System to the Primary Predicate, Invisalign Aligner System. There is sufficient information demonstrating that the proposed subject device provides a reasonable assurance of safety and efficacy. Both products represent new incarnations of an evolving technology with a long history of development.
a) Technological Characteristics:
The technological principle for both the subject Spark/Kappa Aligner and predicate Invisalign Aligner is the treatment of tooth malocclusions using a series of plastic appliances that incrementally moves teeth to a desired end-state. A comparison between the technological characteristics of the Ormco™ Spark™ Aligner System and that of legally marketed predicate device, Invisalign (K143630) has is summarized in Table 5.1, and demonstrates that the design, technology and composition of the Ormco™ SparkTM Aligner System are substantially equivalent (as defined in 21 U.S.C. § 360c(i)) for all regulatory purposes to the predicate devices.
b) Performance Testing:
The performance data compares the software, design, treatment characteristics and treatment process of the Spark Aligner to the predicate Invisalign Aligner. The stress relaxation, flexural and tensile strength were compared to the commercially-available Zendura Aligner material, as well as Invisalign's SmartTrack Aligner material. Comparison of mechanical testing of Spark Aligner material (TruGEN) and Invisalign Aligner material (SmarkTrack) indicates the substantial equivalence of their technological characteristics.
Bench testing of aligners was not performed due to the difficulty of evaluating these device types in a laboratory; however, translucency, staining, shelf life and shipping tests were carried on the thermoformed TruGENTM material which showed acceptable properties for all tested samples. Additionally, several aligner features were tested and found to be acceptable including attachment dimensional accuracy, cutout effects on stability, force evaluation of attachments and bite ramp and hook evaluation at specified cycles.
Biocompatibility testing performed on both TruGEN material and Spark aligners per ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process included cytotoxicity, sensitization and irritation, and intracutaneous reactivity evaluation.
The performance data demonstrates substantial equivalence of the subject Spark Aligner device to the Predicate Invisalign Aligner device.
c) Clinical Performance Data:
6
Clinical performance testing has not been completed for the Ormco™ Spark™ Aligner System. A comprehensive scientific literature review and analysis was conducted by orthodontic specialists on behalf of Ormco (please see Appendix A). Research articles and reports on the predicate device covered various subjects including the efficacy of the aligner on treating different types of orthodontic malocclusions.. There is sufficient information available from scientific literature and from the predicate devices to demonstrate that orthodontic, sequential, clear aligners provide reasonable assurance of safety and effectiveness.
d) Substantial Equivalence Comparison:
The following table (Table 5.1) compares the Ormco™ Spark™ Aligner System to the predicate device, the Invisalign System (K143630), as well as the reference device ClearCorrect (K113618). There is sufficient evidence to demonstrate substantial equivalence of the proposed Spark™ Aligner device to the predicate Invisalign (K143630) device.
| Element | Proposed
Ormco™ Spark™
Aligner System | Primary Predicate
Invisalign System | Reference Predicate
ClearCorrect |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Unknown | K143630 | K113618 |
| 510(k) Sponsor | Sybron Dental
Specialties | Align Technologies | ClearCorrect, Inc |
| Regulation Number | 21CFR872.5470 | 21CFR872.5470 | 21CFR872.5470 |
| Device Classification
Name | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket |
| Product Code | NXC | NXC | NXC |
| Device Class | Class II | Class II | Class II |
| Intended Use | Orthodontic tooth
movement | Orthodontic tooth
movement | Orthodontic tooth
movement |
| Indications for Use | The Ormco™ Spark™
Aligner System is
indicated for the
alignment of teeth
during orthodontic
treatment of
malocclusion in
patients with permanent
dentition (i.e., all
second molars). The
Ormco™ Spark™
Aligner System
positions teeth by way
of continuous gentle
force. | The Invisalign System
is indicated for the
alignment of teeth
during orthodontic
treatment of
malocclusion. | ClearCorrect System is
indicated for the
treatment of tooth
malocclusion in
patients with permanent
dentition (i.e. all
second molars), The
ClearCorrect System
positions teeth by way
of continuous gentle
force |
| Target users | Dental Professionals | Dental Professionals | Dental Professionals |
| Material | Thermoplastic
polyurethane -polyester
composite resin | Thermoplastic
polyurethane -polyester
composite resin | Thermoplastic
polyurethane resin |
| Description of
Appliance Application | Removable | Removable | Removable |
| Element | Proposed
Ormco™ Spark™
Aligner System | Primary Predicate
Invisalign System | Reference Predicate
ClearCorrect |
| Mode of Action | Orthodontic tooth
movement occurs
through forces applied
by the appliance to the
dentition as each tooth
follows the
programmed
displacement based on
a doctor's prescription | Orthodontic tooth
movement occurs
through forces applied
by the appliance to the
dentition as each tooth
follows the
programmed
displacement based on
a doctor's prescription | Orthodontic tooth
movement occurs
through forces applied
by the appliance to the
dentition as each tooth
follows the
programmed
displacement based on
a doctor's prescription |
| Software Used for
Ordering Workflow | Yes | Yes | Yes |
| Attachments | Available | Available | Available |
| Hooks/Cutouts | Available | Available | Not Available |
| Bite ramps | Available | Available | Not Available |
| Pontics | Available | Available | Available |
| Single Use | Yes | Yes | Yes |
| Non-Sterile Packaging | Yes | Yes | Yes |
| Treatment Process | Doctor uploads
Patient's dental scans
into proprietary
software; doctor uses
software for case
viewing and treatment
planning; Ormco
technician receives case
and uses proprietary 3D
software to generate
models for the aligners
based on the
prescription (desired
outcome); Doctor
approves treatment plan
and final treated state;
manufacturer crafts and
produces aligners:
aligners and ships
them to doctor, who
then provides them to
the patient, confirming
fit and design. | The proprietary
Invisalign System 3-D
software generates the
image of a final, treated
state and then
interpolates a series of
images that represent
intermediate teeth
states. The dental
practitioner then
reviews these images to
depict, edit, view,
monitor, and approve
an orthodontic
treatment plan. The
dental practitioner has
the option to reject or
request modifications
to the set-up prior to
approving it for aligner
fabrication. Once the
doctor approves the set-
up, the series of
custom-made aligners
are then manufactured,
packaged, and shipped
to the dental
practitioner to be
dispensed to the patient
for treatment. | Doctor sends patient
scans, molds and
prescription to
ClearCorrect; Utilizing
standard dental
software used for tooth
alignment,
ClearCorrect designs a
series of plastic trays
intended to gradually
realign the patient's
teeth in accordance
with the physician's
prescription. The
prescribing physician
reviews and approves
the model scheme
before the molds are
produced. Once
approved, ClearCorrect
produces the trays,
which are formed of
clear, thin
thermoformed
polyurethane plastic.
The trays are sent back
to the dental health care
professional, who then
provides them to the
patient, confirming fit
and design. |
Table 5.1: Comparison of Proposed and Predicate Devices
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8
e) Substantial Equivalence Conclusion:
The Ormco™ Spark™ Aligner System is substantially equivalent (as defined in 21 U.S.C. $ 360c(i)) for all regulatory purposes to the predicate device Invisalign (K143630). For purposes relevant to this regulatory filing, and as discussed in the previous subsections, technological characteristics, performance testing and clinical literature review indicate the substantial equivalence of the Ormco™ Spark™ Aligner System to the Primary Predicate, Invisalign Aligner System. Both products represent new incarnations of an evolving technology with a long history of development. There is sufficient information demonstrating that the proposed subject device provides a reasonable assurance of safety and efficacy.
9