Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on traditional orthodontic treatment planning software and 3D printing, with no mention of AI or ML in the device description, intended use, or performance studies.

Therapeutic

Yes.
The device is used for the "correction of dental malocclusion" and "positions teeth by way of continuous gentle force," indicating a direct therapeutic action on the body.

Diagnostic

No

The device description indicates that the Clear Moves Aligner is a therapeutic device used for correcting dental malocclusion by physically positioning teeth, rather than a device designed to identify or diagnose a disease or condition. The "Intended Use" also confirms its purpose as a treatment.

SaMD (Software as a Medical Device)

No

The device description clearly states that the device is comprised of physical aligner trays made of biocompatible plastics, which are thermoformed on 3D-printed molds. While software is used in the treatment planning process, the final medical device delivered to the patient is a physical object.

IVD (In Vitro Diagnostic)

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

Here's why:

IVDs are used to examine specimens derived from the human body. The Clear Moves Aligner is a physical device that is placed in the patient's mouth to correct tooth alignment. It does not analyze or test any biological samples.
The intended use is for correcting dental malocclusion. This is a therapeutic purpose, not a diagnostic one.
The device description focuses on the physical properties and manufacturing process of the aligners. It does not mention any components or processes related to analyzing biological samples.

The device is clearly described as a medical device used for orthodontic treatment, which falls under a different regulatory category than IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner positions teeth by way of continuous gentle force.

Product codes (comma separated list FDA assigned to the subject device)

NXC

Device Description

Clear Moves Aligners are comprised of a series of clear, thin, thermoformed removable aligner trays that are designed to correct tooth malocclusions without the use of conventional wire and bracket orthodontic technology. They are made of biocompatible thermoformable plastics, either from a copolyester or a composite of copolyester and polyurethane. They are provided non-sterile and are customized for each patient according to the dental clinician's prescription. The dental health professional (dentist/orthodontist) provides physical or scanned impressions of the patient's teeth to Clear Moves Aligners. A treatment plan using commercially available treatment planning software of either the scanned impression or a scan of the physical impression is sent to the clinician for approval. Upon approval, molds are then created with 3D-printing technology and the clear aligners are thermoformed on the molds and laser marked with patient identifying information and treatment step. The finished, customized aligners are provided to the dental health care professional who provides them to the patient, confirming fit and design. The aligner trays are held in place by pressure and can be removed by the patients at any time.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

physical or scanned impressions of the patient's teeth

Anatomical Site

teeth/dental malocclusion

Indicated Patient Age Range

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

Intended User / Care Setting

dental health professional (dentist/orthodontist)

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)

Bench testing was performed of each aligner thermoplastic material to validate the manufacturing process, to ensure the accuracy of the final thermoformed aligner compared to the initial digital scan. A final report was part of the 510(k) package. In vivo Animal and Human Clinical performance testing are not required for this device category.

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

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K210540, K221097

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

K062828, K180941

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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 shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath in a smaller font.

August 1, 2024

Clear Moves Aligners % Patsy Trisler Regulatory Consultant Trisler Consulting 306 Turnberry Court Lebanon, Indiana 46052

Re: K241137

Trade/Device Name: Clear Moves Aligner Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: April 23, 2024 Received: April 24, 2024

Dear Patsy Trisler:

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 (QS) 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.

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 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,

Bobak Shirmohammadi -S

For Michael E. Adjodha, M.ChE., RAC, CQIA Assistant Director DHT1B: Division of Dental and ENT Devices

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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

Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.

Submission Number (if known)

K241137

Device Name

Clear Moves Aligner

Indications for Use (Describe)

The Clear Moves Aligner is a series of clear, lightweight, plastic appliances indicated for the correction of dental malocclusion in patients with permanent dentition (i.e. all second molars). Clear Moves Aligner 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Submitter: Clear Moves Aligners

Clear Moves Aligners K241137 Traditional Premarket Notification 510(k)

SUBMITTER Name:	Clear Moves Aligners
Address:	100 Jade Block, Park View City
River Edge Housing Scheme
Lahore, Pakistan 54000
Contact Person:	Muhammad Awais
Email:	Mawais2487@gmail.com
Date Prepared:	June 25, 2024
DEVICE Trade
Name:	Clear Moves Aligners
Common Name:	Aligner, Sequential (Clear Braces)
Classification Name	Orthodontic Plastic Bracket
Number	21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Review Panel	Dental
PREDICATE /
REFERENCE
DEVICES	Predicate #1: K210540, Ohlendorf Appliance Laboratory:
Ohlendorf Clear Aligner
Predicate #2: K221097, Ordont Orthodontic Laboratories, Inc.:
SmileSeries
Reference Device: K062828, Dentsply Sirona: Dentsply
Mouthguard and Aligner Materials
DEVICE
DESCRIPTION	Clear Moves Aligners are comprised of a series of clear, thin,
thermoformed removable aligner trays that are designed to
correct tooth malocclusions without the use of conventional
wire and bracket orthodontic technology. They are made of
biocompatible thermoformable plastics, either from a
copolyester or a composite of copolyester and polyurethane.
They are provided non-sterile and are customized for each
patient according to the dental clinician's prescription.
The dental health professional (dentist/orthodontist) provides
physical or scanned impressions of the patient's teeth to Clear
Moves Aligners. A treatment plan using commercially available
treatment planning software of either the scanned impression or
a scan of the physical impression is sent to the clinician for
approval. Upon approval, molds are then created with 3D-
printing technology and the clear aligners are thermoformed on
the molds and laser marked with patient identifying information
and treatment step.
The finished, customized aligners are provided to the dental
health care professional who provides them to the patient,
confirming fit and design. The aligner trays are held in place by
pressure and can be removed by the patients at any time.
MECHANISM OF
ACTION	Each aligner in the set is used for the specified period of time,
usually 2-3 weeks, to exert gentle force to achieve progressive
realignment of the teeth until the final correction has been
achieved. The daily treatment time is approximately 22 hours
or except during eating, based on the clinician's prescribed
treatment plan.
SUMMARY OF
TECHNOLOGICAL
CHARACTERISTICS	The thermoplastic materials used for the manufacture of the
Clear Moves Aligers are the same materials used to make the
predicate aligners.

The software system used is Ortho Analyzer, 2019 ver 1.8.1.0
by 3Shape A/S (Reference device - K180941). It also is the
same as used for the Predicates. It is used for management of
3D scanned orthodontic models, orthodontic diagnosis by
measuring, analyzing, inspecting and visualizing 3D scanned
orthodontic models, virtual planning of orthodontic treatments
by simulating tooth movements, and design of orthodontic
appliances based on 3D scanned orthodontic models. |
| INDICATIONS FOR
USE STATEMENT | The Clear Moves Aligner is a series of clear, lightweight, plastic
appliances indicated for the correction of dental malocclusion in
adult and adolescent patients with permanent dentition (i.e. all
second molars). Clear Moves Aligner positions teeth by way of
continuous gentle force. |
| SAFETY TESTING | Biocompatibility: Testing of the plastic thermoformable
materials used to make these aligners have been provided in
previous 510(k) submissions to FDA. The Reference 510(k) is
included because it was submitted for the copolyester material
to be used for fabrication of many oral appliances using
thermoforming processes. |
| PERFORMANCE
TESTING | Bench testing was performed of each aligner thermoplastic
material to validate the manufacturing process, to ensure the
accuracy of the final thermoformed aligner compared to the
initial digital scan. A final report was part of the 510(k) package.

In vivo Animal and Human Clinical performance testing are not
required for this device category. |
| COMPARISON TO
THE PREDICATE
DEVICE | The Clear Moves Aligner has the same intended use as the
predicate devices. The thermoplastic materials are the same
and the design phase makes the use of the same software as
the predicates. The manufacturing fabrication of the clear
aligner makes use of similar, industry-standard processes with
the similar machines and materials. Any differences in the
specific company processes do not raise new questions of
safety and effectiveness. |
| SUBSTANTIAL
EQUIVALENCE
CONCLUSION | The information and data provided in this 510(k) establish that
the Clear Moves Aligner is substantially equivalent to the
predicate devices in the intended use, design, principle of
operation, technology, including the thermoformable materials
used to make the aligners. See the following SE Comparison
table. |

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Substantial Equivalence Comparison Table
510(k) Number	Proposed Device
K241137	Predicate #1
K210540	Predicate #2
K221097
Device Name	Clear Moves Aligners	Ohlendorf Clear Aligner	Ordont SmileSeries
Manufacturer	Clear Moves Aligners	Ohlendorf Appliance
Laboratory	Ordont Orthodontic
Laboratories, Inc.
Classification
Regulation
Name
Product Code
Class	21 CFR 872.5470
Orthodontic Plastic
Bracket
NXC
2	21 CFR 872.5470
Orthodontic Plastic
Bracket
NXC
2	21 CFR 872.5470
Orthodontic Plastic
Bracket
NXC
2
Indications for
Use	The Clear Moves Aligner
is a series of clear,
lightweight, plastic
appliances indicated for
the correction of dental
malocclusion in patients
with permanent dentition
(i.e. all second molars).
Clear Moves Aligner
positions teeth by way of
continuous gentle force.	... indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion in patients
with permanent dentition
(i.e. all second molars).
...positions teeth by way
of continuous gentle
force.	... indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion in patients
with permanent dentition
(i.e. all second molars).
...positions teeth by way
of continuous gentle
force.
Mode of
Action	The removable appliance
applies gentle forces on
teeth according to the plan
prescribed by the doctor.	same	same
Description of
Use	Each removable
preformed plastic tray,
prescribed by the Dr, is
worn by the patient usually
for a couple weeks, prior
to using the next
sequential aligner tray.	same	same
Material	Thermoformed copolyester
or polyurethane/
copolyester composite	Thermoformed
polyurethane/copolyester
composite	Thermoformed
copolyester
Manufacturing
Process	Forming of plastic sheets
on unique dental models
using thermoforming
machine	same	same
Software Used	Yes, for treatment
planning and 3D printing of
models.	same	same
Prescription
Use	Rx	Same	Same
Biocompatibili
ty	Yes, shown to meet
requirements	Same	Same
Process
Validation	Yes, performed	Same	Same

Substantial Equivalence Comparison Table

Testing |