(90 days)
No
The summary describes a software system for orthodontic treatment planning and aligner design, but it does not mention the use of AI or ML technologies in its description of the software modules or their functions.
Yes
The device is a system of clear plastic aligners that gently move teeth for orthodontic treatment, which is a therapeutic function.
No
The Spark™ Clear Aligner System is indicated for the alignment of teeth (a treatment), and the Spark™ Software System provides tools for management, analysis, simulation, and design related to this alignment, without explicitly stating it diagnoses a condition.
No
The device description clearly states that the system consists of both software modules and physical aligners (thin, clear plastic removable orthodontic appliances). While the software is integral to the treatment planning and aligner design, the final medical device delivered to the patient is a physical product.
Based on the provided information, the SparkTM Clear Aligner System and SparkTM Software System are not In Vitro Diagnostic (IVD) devices.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Spark System's Function: The Spark system is used for the alignment of teeth during orthodontic treatment. It utilizes digital scans of the patient's dentition to plan and manufacture custom aligners.
- Lack of Specimen Analysis: The system does not analyze any biological specimens from the patient's body. Its function is based on the physical structure of the teeth and the application of mechanical forces through the aligners.
Therefore, the Spark Clear Aligner System and Spark Software System fall under the category of medical devices used for treatment and planning, not for in vitro diagnostic purposes.
N/A
Intended Use / Indications for Use
SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
SparkTM Software System:
The Spark™ Software 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, retainers or bracket bonding templatesor 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 Spark™ Clear Aligner System and Spark™ Software 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.
Product codes
NXC, PNN
Device Description
The Ormco 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 design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, 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. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and 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.
The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of:
- . Attachments: 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.
- . Hooks: Hooks may be designed into the aligner, then connected by an elastic to a tooth-bonded button on the opposite arch, to apply additional forces.
- Bite ramps: 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: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.
- Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth, dentition, dental casts
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Dental Professional
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 bench testing according to international standards for Aligners, Sequential has been conducted to determine conformance in regards to:
- o Biocompatibility has been completed for the applicable components.
- Comparative performance testing of the functions of the Proposed device compared to the . cleared stand-a-lone device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Invisalign System (K143630)
Reference Device(s)
Ormco™ Spark™ Aligner System (K182826), Arcad SmileStudio and Aligner System (K192244)
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
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March 22, 2021
Ormco Corporation Frank Ray Director of Regulatory Affairs 200 S Kraemer Blvd Brea, California 92821
Re: K203737
Trade/Device Name: Spark Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC, PNN Dated: December 21, 2020 Received: December 22, 2020
Dear Frank Ray:
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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
1
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 (QS) 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 Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K203737
Device Name SparkTM Clear Aligner System
Indications for Use (Describe) SparkTM Clear Aligner System: The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
SparkTM Software System:
The Spark™ Software 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, retainers or bracket bonding templatesor 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 Spark™ Clear Aligner System and Spark™ Software 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.
| 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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3
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Section V - 510(k) Summary for Spark™ Clear Aligner System K203737
1. Submitter Information:
Ormco Corporation 200 S. Kraemer Blvd, Brea, CA 92821
| Contact Person: | Frank Ray |
|---|---|
| Telephone Number: | (704) 587-7227 |
| Fax Number: | (704) 587-7250 |
Date Prepared: December 21, 2020
2. Device Name:
| Proprietary Name: | Spark™ Clear Aligner System |
|---|---|
| Manufacturer: | Ormco Corporation |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| CFR Number: | 872.5470 |
| Device Class: | II |
| Product Code: | NXC, PNN |
| Predicate Device (Primary): |
- Proprietary Name: Invisalign System (K143630) ●
- Manufacturer: Align Technology, Inc. ●
- Aligner, Sequential ● Common Name:
- Orthodontic Plastic Bracket ● Classification Name:
- CFR Number: 872.5470 ● II
- Device Class:
- NXC Product Code: ●
Reference Device:
| Proprietary Name: | Ormco™ Spark™ Aligner System (K182826) |
|---|---|
| Manufacturer: | Ormco Corporation |
| Common Name: | Aligner, Sequential |
| Classification Name: | Orthodontic Plastic Bracket |
| CFR Number: | 872.5470 |
| Device Class: | II |
- NXC Product Code: ●
4
Reference Device #2:
- . Proprietary Name: Arcad SmileStudio and Aligner System (K192244)
- Manufacturer: ●
- Common Name: Aligner, Sequential
ArcadLab
-
Classification Name: Orthodontic Plastic Bracket
= -
CFR Number: 872.5470
-
o Device Class:
-
Product Code: NXC, PNN o
Description of Device: 4.
o
●
0
The Ormco 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 design and aliqner manufacture are supported by a proprietary software system. The Spark™ Clear Aligner system consists of multiple interfacing software modules; Web, Design, Anatomy, 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. Trained technicians use the Ormco™ Spark™ Aligner Anatomy and 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.
The aligners are individually identified and dispensed to patients and are to be worn in a specific, prescribed sequence. Several treatment options may be integrated into the Ormco Spark aligner consisting of:
- . Attachments: 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.
- . Hooks: Hooks may be designed into the aligner, then connected by an elastic to a tooth-bonded button on the opposite arch, to apply additional forces.
- Bite ramps: 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: Pontics are cavity spaces (that may or may not be "tooth-shaped") built into the aligner per clinician's request to fill voids of missing teeth or other gaps that the clinician may wish to retain during treatment.
- Posterior Bite Turbos: Posterior Bite Turbos (PBT) are designed to prevent complete closure of jaws.
5
Principle of Operation / Mechanism 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 dental clinician's prescription.
5. Indications for Use:
Spark™ Clear Aligner System:
The Spark™ Clear Aligner System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
Spark™ Software System:
The Spark™ Software 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, retainers or bracket bonding templates 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 Spark™ Clear Aligner System and Spark™ Software 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.
6. Description of Substantial Equivalence:
The Spark™ Clear Aligner System design or technical features have not been significantly modified since its clearance in 2018 (Reference Device #1, K182826). This section provides the substantial equivalence rationale for the Spark™ Clear Aligner System and the respective predicate devices with regards to Indications for Use, Technology, and Performance Testing. The differences between the subject device and the predicates do not raise different questions of substantial equivalence.
The similarities between the Spark™ Clear Aligner System (Subject Device) and the Primary Predicate Device Invisalign System (K143630), Reference Device #1 Ormco™ Spark™ Aligner System (K182826), and Reference Device #2 Arcad SmileStudio and Aligner System (K192244) as listed in Table 12.2 below are the Intended Use of the device, Indications for Use, Mode of Action, 3D software description, and treatment process. Also, the Attachments, Hook/Cutouts, Bite Ramps, and Pontics are available options. Furthermore, Biocompatibility testing, Software testing, and Material testing processes are similar.
The difference between the Spark™ Clear Aligner System (Subject Device) and Reference Device #1 Ormco™ Spark™ Aliqner System (K182826) is the material. The Thermoplastic polyurethane-polyester composite resin is the same however the composition slightly varies.
Table 5.2 below compares the Spark™ Clear Aligner System to the Primary predicate device (Invisalign System (K143630)), reference device #1 (Ormco™ Spark™ Aligner
6
System (K182826)), and reference device #2 (Arcad SmileStudio and Aligner System (K192244)) with respect to intended use, technological characteristics and performance testing.
Device Comparison Table:
Table 5.2
| Descriptive
Information | Subject Device
Spark™ Clear
Aligner System | Predicate Device
(Primary)
Invisalign System
(K143630) | Reference
Device #1
Ormco™ Spark™
Aligner System
(K182826) | Reference
Device #2
Arcad
SmileStudio
and Aligner
System
(K192244) | Comparison |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pictorial
Representation | Image: Spark Clear Aligner System | Image: Invisalign System | Image: Ormco Spark Aligner System | Image: Arcad SmileStudio and Aligner System | N/A |
| Regulatory Classification | | | | | |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR
872.5470 | Same as
Predicates |
| Regulation Title | Orthodontic
Plastic Bracket | Orthodontic Plastic
Bracket | Orthodontic Plastic
Bracket | Orthodontic
Plastic Bracket | Same as
Predicates |
| Regulation Class | II | II | II | II | Same as
Predicates |
| Product Code | NXC, PNN | NXC | NXC | NXC, PNN | Same as
Predicates |
| Indications for Use/Intended Use | | | | | |
| Indications for
Use | Spark™ Clear
Aligner System:
The Spark™ Clear
Aligner System is
indicated for the
alignment of
teeth during
orthodontic
treatment of
malocclusion.
Spark™ Software
System:
The Spark™
Software 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, retainers
or bracket
bonding
templates based | The Invisalign System
is indicated for the
alignment of teeth
during orthodontic
treatment of
malocclusion. | 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 Arcad
SmileStudio 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 before
the start of an
orthodontic
treatment. It
can also be
applied during
the treatment
to inspect and | Same as
Predicates
The Indications
for Use for the
bracket is
substantial
equivalent to
the Primary
Predicate
device.
The Indications
for Use for the
software is
substantial
equivalent to
the Reference
device #2. |
7
| Intended Use | 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
Spark™ Clear
Aligner System
and Spark™
Software 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. | 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 Arcad
Aligner System
is indicated for
the treatment
of tooth
malocclusion in
patients with
permanent
dentition (i.e.
all second
molars). The
Arcad Aligner
System
positions teeth
by way of
continuous
gentle force.
The use of the
Arcad Aligner
System and
SmileStudio
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. | N/A | Same as Predicates | | | | | | |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-----------------------|----------------------------|----------|--|-----|-----------------------|
| | Description of
Appliance
Application | Orthodontic tooth movement | movement | Orthodontic tooth movement | movement | Orthodontic tooth movement | movement | | N/A | Same as
Predicates |
| Intended User | Dental
Professional | Dental Professional | Dental Professional | N/A | Same as
Predicates | | | | | |
| Technological Characteristics | | | | | | | | | | |
| 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 | 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. | N/A | Same as
Predicates | | | | | |
8
| | doctor's
prescription. | | | | |
|-----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|-------------------------|
| | | | | | |
| 3-D Software
Description | The Spark™ Clear
Aligner System 3-
D software uses
scanned teeth
data, landmarks
and the clinician's
prescription to
design a
corrected case
setup for the
clinician's review.
The output files
from this
software are sent
to the clinician,
who may suggest
improvements or
approve as-is for
manufacture. The
software is used
to produce pre-
molds and molds
needed for the
manufacturing of
series of custom-
made aligners. | The Align 3-D
Software uses a scan
of a PVS impression
or a digital scan
(which represents an
untreated state) to
generate the image of
a final, treated state
and then interprets a
series of images that
represent
intermediate teeth
states. The dental
practitioner then
reviews these images
and has the option to
reject or request
modifications to the
set-up prior to
approving it for
aligner fabrication.
Once the dental
practitioner approves
the treatment plan,
the software converts
the files to produce
the series of custom-
made aligners. | The Ormco™
Spark™ Aligner
System 3-D
software uses
scanned teeth data,
landmarks and the
clinician's
prescription to
design a corrected
case setup for the
clinician's review.
The output files
from this software
are sent to the
clinician, who may
suggest
improvements or
approve as-is for
manufacture. The
software is used to
produce pre-molds
and molds needed
for the
manufacturing of
series of custom-
made aligners. | N/A | Same as
Predicates |
| Attachments | Available | Available | Available | N/A | Same as
Predicates |
| Hook/Cutouts | Available | Available | Available | N/A | Same as
Predicates |
| Bite ramps | Available | Available | Available | N/A | Same as
Predicates |
| Pontics | Available | Available | Available | N/A | Same as
Predicates |
| Single Use | Yes | Yes | Yes | N/A | Same as
Predicates |
| Non-Sterile
Packaging | Yes | Yes | Yes | N/A | Same as
Predicates |
| Treatment
Process | The Spark™ Clear
Aligner System 3-
D software uses
scanned teeth
data, landmarks
and the clinician's
prescription to
design a
corrected case
setup for the
clinician's review.
The output files
from this
software are sent
to the clinician,
who may suggest
improvements or
approve as-is for
manufacture. The
software is used
to produce pre-
molds and molds | The Align 3-D
Software uses a scan
of a PVS impression
or a digital scan
(which represents an
untreated state) to
generate the image of
a final, treated state
and then interprets a
series of images that
represent
intermediate teeth
states. The dental
practitioner then
reviews these images
and has the option to
reject or request
modifications to the
set-up prior to
approving it for
aligner fabrication.
Once the dental | The Ormco™
Spark™ Aligner
System 3-D
software uses
scanned teeth data,
landmarks and the
clinician's
prescription to
design a corrected
case setup for the
clinician's review.
The output files
from this software
are sent to the
clinician, who may
suggest
improvements or
approve as-is for
manufacture. The
software is used to
produce pre-molds
and molds needed | N/A | Same as
Predicates |
| | needed for the
manufacturing of
series of custom-made aligners. | practitioner approves
the treatment plan,
the software converts
the files to produce
the series of custom-made aligners. | for the
manufacturing of
series of custom-made aligners. | | |
| Material | Thermoplastic
polyurethane-
polyester composite
resin | Thermoplastic
polyurethane-
polyester composite
resin | Thermoplastic
polyurethane-
polyester composite
resin | N/A | Same as
Predicates |
| | Demonstrates
sufficient flexural
strength, stress
retention, stain
resistance, and
transparency for
use as a clear
aligner. | Demonstrates
sufficient flexural
strength, stress
retention, stain
resistance, and
transparency for use
as a clear aligner. | Demonstrates
sufficient flexural
strength, stress
retention, stain
resistance, and
transparency for
use as a clear
aligner. | N/A | Same as
Predicates |
| | Performance testing | | | | |
| Biocompatibility
testing | Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within
a risk
management
system). | Biocompatible
according to ISO
10993-1
(Biological evaluation
of medical devices -
Part 1: Evaluation and
testing within a risk
management
system). | Biocompatible
according to ISO
10993-1
(Biological
evaluation of
medical devices -
Part 1: Evaluation
and testing within a
risk management
system). | N/A | Same as
Predicates |
| | IEC 62304:
2015-06
CONSOLIDATED
VERSION
Edition 1.1 -
Medical device
software -
Software life-
cycle processes. | N/A | IEC 62304:
2015-06
CONSOLIDATED
VERSION
Edition 1.1 - Medical
device software -
Software life-cycle
processes. | N/A | Same as
Predicate #2 |
| | ASTM D790-10:
2010-04-01
Standard Test
Methods for
Flexural
Properties of
Unreinforced and
Reinforced
Plastics and
Electrical
Insulating
Materials. | N/A | ASTM D790-10:
2010-04-01
Standard Test
Methods for Flexural
Properties of
Unreinforced and
Reinforced Plastics
and Electrical
Insulating
Materials. | N/A | Same as
Predicate #2 |
9
Non-Clinical Test Data:
Performance bench testing according to international standards for Aligners, Sequential has been conducted to determine conformance in regards to:
- o Biocompatibility has been completed for the applicable components.
- Comparative performance testing of the functions of the Proposed device compared to the . cleared stand-a-lone device.
Furthermore, the performance of the Spark™ Clear Aligner System has been verified utilizing the following standards:
10
- ISO 10993-1:2018: Biological evaluation of medical devices Part 1: Evaluation and . testing within a risk management process.
- o ISO 10993-5:2009: Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
- . ISO 10993-6:2016: Biological evaluation of medical devices - Part 6: Tests for local effects after implantation.
- ISO 10993-10:2010: Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization.
- ISO 10993-11:2017: Biological evaluation of medical devices—Part 11: Tests for systemic ● toxicity.
- ISO 7405:2018 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry.
- ISO 14971:2007: Medical devices Application of risk management to medical devices. ●
- . IEC 62304:2015-06: Medical device software - Software life-cycle processes.
- IEC 62366-1:2015 Medical devices Part 1: Application of usability engineering to medical ● devices.
- o ASTM D790-10: 2010: Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials.
- . ASTM F1980-16: 2016: Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices.
Clinical Performance Data:
Clinical data is not needed to characterize performance and establish substantial equivalence. The non-clinical test data characterize all performance aspects of the device based on wellestablished scientific and engineering principles. Clinical testing has not been conducted on this product.
Conclusion as to Substantial Equivalence:
Based on a comparison of intended use, indications, material composition, technological characteristics, principle of operation, features and performance data, the Spark™ Clear Aligner System is deemed to be substantially equivalent to the predicate device.