Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions proprietary software for generating and interpolating images for treatment planning, but it does not explicitly state the use of AI or ML algorithms. The process described appears to be based on geometric modeling and interpolation, reviewed and approved by a dental practitioner. There is no mention of training or test sets, which are common indicators of ML use.

Therapeutic

Yes
The device, SunClear Aligners, is described as a system of orthodontic appliances that "gently move the patient's teeth in small increments from their original state to a more optimal, treated state" for the "treatment of tooth malocclusion." This indicates a direct therapeutic action on the patient's anatomy to correct a medical condition.

Diagnostic

No

Explanation: The device is indicated for the treatment of tooth malocclusion, and the software generates images for treatment planning, not for diagnosing a condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the SunClear Aligner system consists of both "thin, clear plastic removable orthodontic appliances (aligners)" and "proprietary 3-D software." The aligners are a physical component of the system used to treat the patient.

IVD (In Vitro Diagnostic)

Based on the provided information, the SunClear Aligner system is not an In Vitro Diagnostic (IVD).

Here's why:

IVDs are used to examine specimens derived from the human body. The SunClear Aligner system uses dental impressions or scans of the patient's teeth, which are not considered specimens derived from the human body in the context of IVD regulation.
The intended use is for the treatment of tooth malocclusion. This is a therapeutic purpose, not a diagnostic one. IVDs are used to diagnose diseases or conditions.
The device description focuses on the physical aligners and software for treatment planning. There is no mention of analyzing biological samples or providing diagnostic information about a patient's health status.

The SunClear Aligner system is a medical device used for orthodontic treatment.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.

Product codes

NXC

Device Description

SunClear Aligners consists of a series of doctor-prescribed, thin, clear plastic removable orthodontic appliances (aligners) and proprietary 3-D software. The aligners gently move the patient's teeth in small increments from their original state to a more optimal, treated state. SunClear Aligners are intended as an alternative to conventional bracket technology and fixed appliances for the treatment of patients with malocclusion.
The proprietary software generates the final image of a treated state and then interpolates a series of images that represent the intermediate teeth states. The dental practitioner then reviews these images to depict, edit, view, monitor, and approve an orthodontic treatment plan.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

teeth

Indicated Patient Age Range

patients with permanent dentition (i.e. all second molars)

Intended User / Care Setting

Dentist/orthodontist / Home

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)

Non-Clinical Testing Summary -
Biocompatibility - No testing was performed as the material of the aligners is identical to the K062828 - Dentsply International - Aligner materials which has similar intended use and patient contact.
Bench testing - SunClear Aligners are made of similar aligner material as the predicate. The identified aligner material has been cleared under K06282 for the intended use. We have performed flexural strength of the subject device and predicate materials.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K172765

Reference Device(s)

K150702

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 16, 2019

Sun Dental Laboratories, LLC % Paul Dryden President Sun Dental Laboratories, LLC / ProMedic, LLC 131 Bay Point Dr. NE St. Petersburg, Florida 33704

Re: K190394

Trade/Device Name: SunClear Aligner system Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: November 13, 2019 Received: November 14, 2019

Dear Paul Dryden:

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

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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 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 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-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,

for Srinivas Nandkumar, Ph.D. 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

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Indications for Use

510(k) Number (if known) K190394

Device Name Sun Clear Aligner system

Indications for Use (Describe)

The SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligners positions teeth by way of continuous gentle force.

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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Date Prepared:	13-Dec-2019
Sun Dental Laboratories, LLC
1800 9th Ave N
St. Petersburg, FL 33713
T - 727-561-9777
Official Contact:	Derek Diasti, President
Submission Correspondent:	ProMedic, LLC
Paul Dryden, President
131 Bay Point Dr. NE
St. Petersburg, FL 33704
E - paul.dryden@promedic.cc
T – 239-307-6061
Proprietary or Trade Name:	SunClear Aligner system
Common/Usual Name:	Sequential aligner and software
Classification Name:	21CFR 872.5470
NXC - Aligner, Sequential
Class II
Predicate Device:	K172765 - Smart Moves Complete
Reference Device:	K150702 - eXceed Computerized Precision Bracket
Placement Solution

Device Description:

Orthodontic treatment is conventionally performed using brackets and arch wires. A bracket is bonded to each tooth and a wire is inserted with the goal of moving each tooth to a desired final treatment position. An alternative to traditional bracket treatment has been in existence for the past 20 years. This alternative treatment uses clear plastic aligners to gradually move the teeth. The aligners are designed in a series of incremental stages. A patient wears each aligner stage for a period of two weeks to accomplish the programmed tooth movement. Once tooth movement has been accomplished for a given stage the current aligner is removed and the next aligner in the sequence is worn. This method of orthodontic treatment is popular with patients because it provides a virtually invisible appliance and avoids the appearance of braces on the teeth.

Indications for use:

SunClear Aligner system is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). SunClear Aligner positions teeth by way of continuous gentle force.

Patient Population:

Patients needing treatment of tooth malocclusion

Environments of use: Home

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510(k) Summary

The following table presents the comparison to support substantial equivalence.

The table below compares the key features of the proposed SunClear Aligner system with the identified predicate – K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution and demonstrates that this proposed device can be found substantially equivalent.

Indications for Use - The Indications for Use are similar to predicate - K172765 - Smart Moves Complete. There is a difference between the proposed SunClear Aligner system and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution, however, the software utilized in this submission is identical to what was cleared under K150702 and K172765.

Discussion - The Indications for Use are similar to predicate - K172765 - Smart Moves Complete.

Technology and construction - The technology and construction are similar to predicate -K172765 - Smart Moves Complete. There is a difference between the proposed SunClear Aligner system and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution, in that K150702 is for brackets.

Discussion - The software is identical, and the aligners are manufactured the same as the predicate including the identical materials.

Environment of Use – The environments of use are similar to predicate - K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution.

Discussion - The environment is similar to predicate and reference, namely - home use.

Patient Population – The patient population is similar to predicate K172765 – Smart Moves Complete and the reference K150702 - eXceed Computerized Precision Bracket Placement Solution Discussion - The patient population is similar to the predicate - K172765 - Smart Moves Complete.

Workflow - The patient actively interacts with the dentist / orthodontist. Interactions include the patient visits a dental office; Dentist/orthodontist completes a comprehensive exam, takes xrays and clears patient for orthodontic treatment; Dentist/orthodontist takes dental impressions or scans of patient and completes diagnostic records and sends to the lab who in turn fabricates models, thermoforms aligners, and sends aligners to the dentist to confirm patient fit.

Non-Clinical Testing Summary -

Biocompatibility - No testing was performed as the material of the aligners is identical to the K062828 - Dentsply International - Aligner materials which has similar intended use and patient contact.

Bench testing - SunClear Aligners are made of similar aligner material as the predicate. The identified aligner material has been cleared under K06282 for the intended use. We have performed flexural strength of the subject device and predicate materials.

Substantial Equivalence Conclusion -

The sponsor has demonstrated through performance testing, design and features, and non-clinical testing that the proposed device and predicate have been found to substantially equivalent.

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510(k) Summary

Device Comparison	SunClear Aligner system	Predicate	Reference
		K172765 – Smart Moves Complete	K150702 - eXceed Computerized
Precision Bracket Placement Solution
Model	SunClear Aligner system	Smart Moves Complete	eXceed Software
Indications for Use	SunClear Aligner system is indicated for
the treatment of tooth malocclusion in
patients with permanent dentition (i.e. all
second molars). SunClear Aligners
positions teeth by way of continuous
gentle force.	Smart Moves Complete is indicated for
the treatment of tooth malocclusion in
patients with permanent dentition (i.e. all
second molars). Smart Moves Complete
positions teeth by way of continuous
gentle force.	eXceed Computerized Precision Bracket
Placement Solution is a software system
intended for use as an aid in orthodontic
treatment planning to correct
Malocclusions in Orthodontic Patients.
For use by dental professionals trained in
orthodontic treatment, including
radiographic analyses and treatment
planning. eXceed Computerized
Precision Bracket Placement Solution is
intended for use with commercially
available brackets currently used in
standard orthodontic treatment. The end
product is an indirect bonding tray for
use by the Dental professional to place
multiple brackets at the same time.
Target Population	Patients needing treatment of tooth
malocclusion	Patients needing treatment of tooth
malocclusion	Patients needing treatment of tooth
malocclusion
Environment of Use	Home	Home	Home
OTC or Rx	Rx	Rx	Rx
Design	Single Patient, multi-use	Single Patient, multi-use	Single Patient, multi-use
Device Comparison	SunClear Aligner system	Predicate
K172765 - Smart Moves Complete	Reference
K150702 - eXceed Computerized
Precision Bracket Placement Solution
Device Description	SunClear Aligners consists of a series of
doctor-prescribed, thin, clear plastic
removable orthodontic appliances (aligners)
and proprietary 3-D software. The aligners
gently move the patient's teeth in small
increments from their original state to a
more optimal, treated state. SunClear
Aligners are intended as an alternative to
conventional bracket technology and fixed
appliances for the treatment of patients with
malocclusion.
The proprietary software generates the final
image of a treated state and then interpolates
a series of images that represent the
intermediate teeth states. The dental
practitioner then reviews these images to
depict, edit, view, monitor, and approve an
orthodontic treatment plan.	Smart Moves Complete consists of a
series of doctor-prescribed, thin, clear
plastic removable orthodontic
appliances (aligners) and proprietary
3-D software. The aligners gently
move the patient's teeth in small
increments from their original state to
a more optimal, treated state. Smart
Moves Complete is intended as an
alternative to conventional bracket
technology and fixed appliances for
the treatment of patients with
malocclusion.
The proprietary software generates the
final image of a treated state and then
interpolates a series of images that
represent the intermediate teeth states.
The dental practitioner then reviews
these images to depict, edit, view,
monitor, and approve an orthodontic
treatment plan.	Using the images provided by the Dental
Professional, the software creates a 3D
model and identifies the ideal placement
of the brackets. The file is sent to the
Dental Professional for review and
approval. The Dental Professional may
adjust the final position of the bracket if
desired. A 3D model is printed, and the
brackets are placed on the model in the
prescribed location, approved by the
Orthodontist. An indirect bonding tray is
fabricated with the brackets
in place. The tray and brackets are sent
to the Dental professional. The Dental
Professional places the indirect tray
using their chosen commercially
available bracket adhesive
Technology	eXceed Software	eXceed Software
(referred to as SmartMoves)	eXceed Software
	Using the images provided by the Dental
Professional, the software creates a 3D
model and identifies the ideal placement of
the aligners.	Using the images provided by the Dental
Professional, the software creates a 3D
model and identifies the ideal placement
of the aligners.	Using the images provided by the Dental
Professional, the software creates a 3D
model and identifies the ideal placement
of the brackets.
Workflow	- Patient visits a dental office

Dentist/orthodontist completes a
comprehensive exam, takes x-rays and clears
patient for orthodontic treatment
Dentist/orthodontist takes dental impressions
or scans of patient and completes diagnostic
records and sends to the lab. - Lab fabricates
models, thermoforms aligners, and sends back
to dentist to confirm patient fit. | Not known | Active patient clinician interaction
throughout the treatment period |
| Device Comparison | SunClear Aligner system | Predicate
K172765 – Smart Moves Complete | Reference
K150702 - eXceed Computerized
Precision Bracket Placement Solution |
| 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. | N/A |
| Method of Use | Each preformed plastic tray is
worn by the patient as prescribed by the
dental practitioner, usually a few
weeks prior to using the next
sequential aligner tray | Each preformed plastic tray is
worn by the patient as prescribed by the
dental practitioner, usually a few
weeks prior to using the next
sequential aligner tray | N/A |
| Biocompatibility /
Materials | K062828
Dentsply International Aligner Material | Great Lakes Splint Biocryl | N/A |
| Performance testing | Strength testing | Strength testing | N/A |

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510(k) Summary

K190394

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