(90 days)
Not Found
No
The description mentions "specialized orthodontic CAD/CAM software" and "interprets a series of images," but there is no explicit mention of AI, ML, or related terms like deep learning or neural networks. The process described appears to be based on traditional CAD/CAM and image processing techniques for generating treatment plans and models.
Yes
The device is indicated for the "treatment of tooth malocclusion" and "position teeth by way of continuous gentle force," which are therapeutic actions.
No
This device is an aligner for the treatment of tooth malocclusion, which is a therapeutic rather than a diagnostic function. While it uses digital data for treatment planning, the device itself does not diagnose or detect conditions.
No
The device description clearly states that the device is a series of "thermoformed plastic aligners," which are physical hardware components. While software is used in the design and manufacturing process, the final medical device delivered to the patient is a physical product.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Clear Moves Aligners Function: The Clear Moves Aligners are physical devices worn in the mouth to mechanically move teeth. They are used for treatment of malocclusion, not for analyzing biological samples.
- Intended Use: The intended use clearly states "treatment of tooth malocclusion," which is a mechanical correction, not a diagnostic process involving in vitro analysis.
- Device Description: The description details the physical nature of the aligners and how they are used to apply force to teeth.
- Input: The input is a mold or scan of the patient's dentition, which is used for planning and manufacturing the physical device, not for in vitro analysis.
- Anatomical Site: The anatomical site is the teeth/dentition, where the physical device is applied.
The process involves digital imaging and software for planning, but the core function of the device itself is mechanical tooth movement, not in vitro analysis of biological samples.
N/A
Intended Use / Indications for Use
The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.
Product codes
NXC
Device Description
The Clear Moves Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of the teeth to the final desired position. The sequential aligners introduce increments that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.
A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved, the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Space Maintainers Laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
digital or traditional mold impression of the patient's dentition
Anatomical Site
teeth/dentition
Indicated Patient Age Range
patients with permanent dentition (i.e. all second molars)
Intended User / Care Setting
dental health professional (e.g. orthodontist or dentist) / Not Found
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 was conducted to verify that the Clear Moves Aligner meets all design specifications. This included an internal manufacturing validation to demonstrate the dimensional accuracy of the manufacturing process. Translational measurements were within 0.150mm (150microns) of the target input value, which is the predefined tolerance. The final aligner fitness was evaluated by a trained physician, and all aligners in the study passed and were deemed an excellent fit. Biocompatibility evaluation was also conducted in accordance with ISO 10993-1, with tests for in vitro cytotoxicity, skin irritation, sensitization, subacute/subchronic toxicity, and genotoxicity. Non-clinical physical properties of the device material were tested according to ASTM standards for tensile strength, elongation, elastic modulus, and flexural properties. No clinical testing was necessary due to the well-established clinical performance of sequential aligners and the device's equivalent indication and method of use to its predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K223141 STR8 Clear Aligners STR8 Oral Care
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.5470 Orthodontic plastic bracket.
(a)
Identification. An orthodontic plastic bracket is a plastic device intended to be bonded to a tooth to apply pressure to a tooth from a flexible orthodontic wire to alter its position.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image contains the logos of the U.S. Department of Health and Human Services and the U.S. Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
April 4, 2024
Space Maintainers Laboratories (SML) % Na Zhang Consultant/Project Manager DeviceMC LLC. 1 Bav Street Rancho Mission Viejo, California 92694
Re: K240038
Trade/Device Name: Clear Moves Aligners Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 3, 2024 Received: January 5, 2024
Dear Na Zhang:
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.
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"
1
(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 OS 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
2
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
K240038
Device Name
Clear Moves Aligners
Indications for Use (Describe)
The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position 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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4
510(k) Summary
SUBMITTER
| Date Prepared: | April 1, 2024 |
|---|---|
| Submitter: | Space Maintainers Laboratories(SML) |
| 5922 9129 Lurline Ave | |
| Chatsworth, CA 91311-5922 | |
| United States of America | |
| Official Contact: | Scott Veis |
| COO | |
| TEL:800-423-3270 | |
| Email: scottv@smlglobal.com |
DEVICE
| Trade/Proprietary Name: | Clear Moves Aligners |
|---|---|
| Common Name: | Aligners, Sequential |
| Classification Name : | Orthodontic Plastic Bracket |
| Classification Regulations: | 21CFR 872.5470 |
| Product Code: | NXC |
| Device Classification: | Class II |
| Classification Panel: | Dental Products Panel |
| Reviewing Branch | Dental Devices Branch |
PRIDICATE DEVICE
Primary Predicate Device: K223141 STR8 Clear Aligners STR8 Oral Care
DEVICE DESCRIPTION
The Clear Moves Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement of the teeth to the final desired position. The sequential aligners introduce increments that move teeth by way of gentle continuous force. The aligners are to be worn 20 to 22 hours a day and are to be removed for eating and for cleaning. Generally the typical wear time for each aligner is a two weeks duration prior to being replaced by the next aligner in sequence.
A digital or traditional mold impression of the patient's dentition is provided by a dental health professional (e.g. orthodontist or dentist). From the digital data of the patient's dentition, a specialized orthodontic CAD/CAM software is used to develop treatment plan. Using the software, dental technicians design a series of intermediate models
5
corresponding to each stage of treatment, gradually realigning the patient's teeth according to the dental health profession's prescription.
The prescribing doctor reviews and approves the model scheme and treatment plan before the molds/models are produced.
Once approved. the specialized orthodontic software is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Space Maintainers Laboratories produces the aligner trays by thermal forming a plastic sheet over each model in the treatment plan. The trays are provided to the dental health care professional who provides them to the patients in sequential stages, confirming fit and design. The dental health professional monitors treatment from the moment of the first aligner is delivered to when the final aligner is finished and treatment is complete. The aligners are held in place by pressure and can be removed by the patient at any time.
INDICATIONS FOR USE
The Clear Moves Aligners are indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Clear Moves Aligners position teeth by way of continuous gentle force.
COMPARISON OF TECHNOLOGICAL WITH THE PREDICATE DEVICE
The subject device is substantial equivalent in intended use and technological characteristics to predicate devices mentioned above. Below is a summary table comparing the subjective device with the primary predicate and an additional reference predicate device.
| Features | Submission Device | Predicate Device | Substantial
Equivalent
Comparison |
|-------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------|
| Manufacture | Space Maintainers
Laboratories (SML) | STR8 Oral Care | N/A |
| Trade Name | Clear Moves
Aligners | STR8 Clear Aligners | N/A |
| 510(k)
Number | N/A | K223141 | N/A |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classifications | Class II | Class II | Same |
| Product Code | NXC | NXC | Same |
| Indications for
Use | The Clear Moves
Aligners are
indicated for the | The STR Clear Aligner is
indicated for the Alignment
of teeth during orthodontic | Same, slight
difference in
wording will |
| | treatment of tooth
malocclusion in
patients with
permanent dentition
(i.e., all second
molars). The Clear
Moves Aligners
position teeth by way
of continuous gentle
force. | treatment of malocclusions
by way of continuous gentle
forces | not affect the
intended
use/indications
for use |
| Mode of
Actions | Alignment of teeth
by application of
continuous gentle
force, by sequential
use of preformed
plastics trays | Each performed Plastic tray
is worn in sequence by the
patient as prescribed by the
dental practitioner.
Orthodontic movement
occurs through continuous
gentle forces applied to the
dentition as each tooth
follows the programmed
displacement based on the
doctor's prescription | Same |
| Material | Zendura FLX
(copolyester and poly
urethane composite) | Zendura FLX (copolyester
and poly urethane
composite) | Same |
| Biocompatible | Yes | Yes | Same |
| Software | Guidemia Ortho+
(K162850) | Treatment Planning System
(K213916) | Different, does
not affect
substantial
equivalence |
| Software
Design
Process | The standard ortho
dental software uses
a scan of tooth
impression or a
digital scan to
generate the image of
a final, treated state
and then interprets a
series of images that
represent
intermediate teeth
states. Once the
dental practitioner
approves the
treatment plan, the
software converts the | Standard dental software
for tooth alignment uses
digital scan(untreated state)
to generate the image of a
final provisional treated
state and then interprets a
series of images that
represent intermediate teeth
states. The dental
practitioner then review
these images and has option
to reject or request
modifications to the set-up
prior to approving for
aligner fabrication. Once
the dental practitioner | Similar, does
not affect
substantial
equivalence |
| | files to produce the
series of patient
specific aligners. | approves the treatment plan,
the software converts the
files to produce a series 3 D
models used to produce | |
| Manufacture
Method | Thermoforming | thermoformed aligners
Thermoforming | Same |
| Rx or OTC | Rx | Rx | Same |
| Sterility | Non-sterile | Non-sterile | Same |
| Design | Image: aligners | Image: aligners | Similar, does
not affect
substantial
equivalence |
6
7
Substantial Equivalence Discussion:
The indications of use of the Clear Moves aligners is same as the predicate device. Slight difference in wording will not affect the intended use of the devices as they are both intended for correcting dental malocclusion patients with permanent dentition.
The subjective has very similar technological characteristics as to the predicate device in material, principle of operation, manufacturing process, design and clinical application. The only difference compared to Clear Moves Aligner with the predicate device is the software used to treatment planning and creation of models/mold. However both software are FDA cleared, under product code PNN for its intended use, which will not affect substantial equivalence of safety and effectiveness.
Therefore, the Clear Moves Aligner is considered to be substantially equivalent to the predicate device based on a comparison of intended use and technological characteristics.
Non-Clinical PERFORMANCE DATA
Non-clinical testing have been conducted to verify that the Clear Moves Aligner meets all design specification which supports the conclusion that it's substantially equivalent (SE) to the predicate device.
Software used for treatment planning and creation of models/mold for Clear Moves Aligner is Guiemia Ortho + manufactured by Guidemia Technologies. LLC. It is a 510(K) clearance (K162850) software under product code PNN for intended use.
An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Clear Moves Aligner. The critical aspects of the manufacturing process were assessed for accuracy. The final aligner fitness was evaluated according to the in-house fitness acceptance criteria.
8
Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation by a trained physician demonstrate all the aligners including in the study passed and were deemed an excellent fit .
The biocompatibility evaluation determined that Clear Moves Aligner and the predicate devices are composed of the same material, fabricated by the similar manufacturing processes, and has identical method of use, which can conclude that Clear Moves Aligners are biocompatible for its intended use.
Biocompatibility testing for the aligner material, the only patient contacting material, was conducted by the material manufacture in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".
| • Test for in vitro cytotoxicity : Elution Method | ISO10993-5 |
|---|---|
| • Skin Irritation Test in New Zealand White Rabbits | ISO10993-10 |
| • Sensitization Test in Guinea Pigs | ISO10993-10 |
- Sensitization Test in Guinea Pigs ●
- Subacute/Subchronic Toxicity Testing . ISO 10993-11 Genotoxicity . ISO 10993-3
Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Clear Moves Aligner .
-
Test for in vitro cytotoxicity : Minimal Essential Media (MEM) Elution ISO10993-5
Non-Clinical physical properties of the device material have been tested by the material manufacture complying with the following standard -
Tensile Strength at Break(MPa) ASTM D638
-
Tensile Stress at Yield (MPa) ASTM D638
-
Elongation at Break (%) ASTM D638
-
Elongation at Yield (%) ● ASTM D638
-
Elastic Modulus (MPa) ASTM D638
-
Flexural Strength ASTM D790
-
Flexural Elastic Modulus ASTM D790 ●
CLINICAL PERFORMANCE DATA
The clinical performance of sequential aligners (product code NXC) has been well established since the first device of this category was cleared by the FDA in 1998. The Clear Moves aligners have equivalent indication and method of use to its predicate, therefore there was no clinical testing necessary to support this device.
9
CONCLUSIONS
The subject device has very similar technological characteristics (i.e. design, function, principle of operation, materials, biocompatibility and sterilization) to the predicate device . The intended use and indications for use of the subject device are the same as the predicate device.
In conclusions, the subject device is substantially equivalent based on a comparison of intended use, and technological characteristics. Therefore, the device is considered to be safe and effective for its intended use.