(183 days)
No
The summary describes a system of physical aligners and retainers and does not mention any software or algorithms that would suggest the use of AI or ML.
Yes
The device is indicated for the "treatment of tooth malocclusion" and "progressively reposition the teeth by way of continuous gentle force," which describes a therapeutic action.
No
The device description indicates that the ClearCorrect System is a sequential series of orthodontic appliances (aligners, retainers, engager templates) used to reposition teeth, not to diagnose a condition. Its function is therapeutic, applying force to align teeth, rather than identifying or characterizing a medical condition.
No
The device description explicitly details physical components (aligners, retainers, engager templates) which are thermoformed orthodontic appliances intended for intra-oral use. The performance studies also include testing on physical properties of these materials.
Based on the provided information, the ClearCorrect System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- ClearCorrect System Function: The ClearCorrect System is an orthodontic appliance used intra-orally to physically reposition teeth. It does not analyze biological specimens.
- Intended Use: The intended use is for the treatment of tooth malocclusion, which is a physical condition, not a diagnosis based on laboratory analysis.
- Device Description: The description details physical appliances (aligners, retainers, templates) used directly in the mouth.
- Performance Studies: The performance studies listed focus on the physical properties, usability, and biocompatibility of the materials and system, not on the accuracy of diagnostic measurements.
Therefore, the ClearCorrect System falls under the category of a medical device used for treatment, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The aligners of the ClearCorrect System are a sequential series of clear thermoformed orthodontic appliances that, when worn in the prescribed sequence and duration, progressively reposition the teeth. The aligner is an orthodontic appliance intended for intra-oral use. Individual devices will be used between 20 – 22 hours per day for a period ranging from one to three weeks The corrective force to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the tray. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force in directions that cannot be achieved by engaging with tooth surfaces.
The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.
The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intra-oral / teeth
Indicated Patient Age Range
Adults (> 21 y.o.), Adolescents (12 – 21 y.o. having permanent second molars)
Intended User / Care Setting
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)
Assessment of the risks associated with the subject device presented in this submission indicate that the following studies establish the substantial equivalence of the subject device to the identified predicate and reference devices:
- Package integrity via simulated transport test per ISTA 2A
- Validation of shelf life per ASTM F1980
- Biocompatibility per the ISO 10993 series standards
- Water absorption testing per ISO 62
- Tensile performance testing per ISO 527-3
- Flexural performance testing per ISO 178
- Impact performance testing per ISO 8256
- Tear resistance testing per ISO 6383-1
- Fatigue resistance testing per ASTM D7774
- Stress relaxation testing
- Dimensional stability per internal methods
- Usability testing per IEC 62366-1
- Software development per IEC 62304
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.
K113618, ClearCorrect System, ClearCorrect LLC
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.
K182826, Ormco™ Spark™ Aligner System, Sybron Dental Specialties
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
§ 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.
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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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
August 6, 2021
Christopher Klaczyk, VP, Head of Regulatory Affairs ClearCorrect LLC 21 Cypress Boulevard, Suite 1010 Round Rock, TX 78665 USA
Re: K210320
Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: May 3, 2021 Received: May 5, 2021
Dear Christopher Klaczyk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to 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 and ENT 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) K210320
Device Name ClearCorrect System
Indications for Use (Describe)
The ClearCorrect System is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth by way of continuous gentle force.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K210320 |
|---|---|---|
| Submitter: | ClearCorrect, LLC | |
| 21 Cypress Boulevard | ||
| Suite 1010 | ||
| Round Rock, TX 78665 | ||
| Contact Person: | Christopher Klaczyk | |
| Head of Regulatory Affairs | ||
| +1 (512) 831-5128 | ||
| christopher.klaczyk@clearcorrect.com | ||
| Date Prepared: | July 30, 2021 | |
| Product Code(s): | NXC (21 CFR 872.5470) | |
| Device Class: | II (21 CFR 872.5470) | |
| Classification Panel: | Dental Devices (DHT1B) | |
| Classification Name: | Orthodontic plastic bracket (21 CFR 872.5470) | |
| Common Name | Aligner, Sequential | |
| Proprietary Name: | ClearCorrect System | |
| Predicate Device(s): | K113618, ClearCorrect System, ClearCorrect LLC | |
| Reference Device(s): | K182826, Ormco™ Spark™ Aligner System, Sybron Dental | |
| Specialties | ||
| Device Description: | The aligners of the ClearCorrect System are a sequential | |
| series of clear thermoformed orthodontic appliances that, | ||
| when worn in the prescribed sequence and duration, | ||
| progressively reposition the teeth. The aligner is an | ||
| orthodontic appliance intended for intra-oral use. Individual | ||
| devices will be used between 20 – 22 hours per day for a | ||
| period ranging from one to three weeks The corrective force | ||
| to align teeth are primarily generated by the difference | ||
| between the starting tooth position and the planned tooth | ||
| position defined by the tray. Features can be added to the | ||
| aligner that engage with composite resin tooth attachments to | ||
| improve aligner retention and/or to apply force in directions | ||
| that cannot be achieved by engaging with tooth surfaces |
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The retainers of the ClearCorrect System are clear thermoformed appliances intended to keep the teeth from relapsing after they have been treated with aligners. Retainers are an optional component of aligner therapy. Retainers are typically prescribed for use at the conclusion of aligner treatment but can be prescribed at other times should there be a need to interrupt aligner treatment.
The engager templates of the ClearCorrect System are clear thermoformed appliances used to accurately apply composite resin attachments to the teeth as needed to achieve the desired tooth movement. The use of engagers and engager templates is an optional component of aligner treatment. Cavities are formed in the film having the desired shape, orientation and tooth position of the engager attachments to be bonded to the patient's teeth. At the time of use, the clinician fills the cavities in the engager template with light-curing composite resin. The engager template is then placed onto the patient's teeth and the resin cured. Once the resin is cured, the engager template is removed and discarded.
Image /page/4/Picture/3 description: The image shows a clear aligner on a pink background. The aligner is a dental device used to straighten teeth. It is made of clear plastic and is designed to fit over the teeth. The aligner is custom-made for each patient and is worn for a specific period of time. The pink background is a solid color and provides a contrast to the clear aligner.
Picture of Device
Indications For Use:
Materials:
The ClearCorrect aligners are produced from multi-laver polymer film having the trade name ClearQuartz™. The film consists of one laver of elastomeric polyurethane sandwiched between two-layers of rigid co-polyester.
The ClearCorrect System is indicated for the treatment of
by way of continuous gentle force.
tooth malocclusion in patients with permanent dentition (i.e. all second molars). The ClearCorrect System positions teeth
The ClearCorrect retainers are produced from single-layer rigid polyurethane film.
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The ClearCorrect engager templates are produced from single-layer rigid PETG film.
| Technological
Characteristics: | A comparison of the relevant technological characteristics
between the subject and primary predicate devices is provided
in the table that follows. |
| ----------------------------------- | ----------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
Performance Data: Assessment of the risks associated with the subject device presented in this submission indicate that the following studies establish the substantial equivalence of the subject device to the identified predicate and reference devices:
- Package integrity via simulated transport test per ISTA 2A ●
- Validation of shelf life per ASTM F1980
- Biocompatibility per the ISO 10993 series standards
- . Water absorption testing per ISO 62
- . Tensile performance testing per ISO 527-3
- Flexural performance testing per ISO 178
- Impact performance testing per ISO 8256
- Tear resistance testing per ISO 6383-1
- Fatigue resistance testing per ASTM D7774
- . Stress relaxation testing
- Dimensional stability per internal methods
- Usability testing per IEC 62366-1
- . Software development per IEC 62304
Conclusions: Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
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| Feature | Subject Device
ClearCorrect System | Primary Predicate Device
ClearCorrect System
(K113618) | Reference Device
Ormco™ SparkTM Aligner
System
(K182826) | Equivalence Discussion |
|-----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The ClearCorrect System is
indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e. all
second molars). The
ClearCorrect System positions
teeth by way of continuous
gentle force. | The ClearCorrect System is
indicated for the treatment of
tooth malocclusion in patients
with permanent dentition (i.e. all
second molars). The
ClearCorrect System positions
teeth by way of continuous
gentle force. | The Ormco™ SparkTM 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™
SparkTM Aligner System
positions teeth by way of
continuous gentle force. | Identical
The indication for the Subject
device is the same as for the
Primary Predicate device. |
| Target
Patient
Population | Adults (> 21 y.o.)
Adolescents (12 – 21 y.o. having
permanent second molars) | Adults (> 21 y.o.)
Adolescents (12 – 21 y.o. having
permanent second molars) | Adults (> 21 y.o.)
Adolescents (12 – 21 y.o. having
permanent second molars) | Identical |
| Mode of
Action /
Operating
Principle | The aligner is an orthodontic
appliance intended for intra-oral
use. Individual devices will be
used between 20 – 22 hours per
day for a period ranging from
one to three weeks
The corrective forces to align
teeth are primarily generated by
the difference between the
starting tooth position and the
planned tooth position defined
by the tray. Features can be
added to the aligner that engage
with composite resin tooth
attachments to improve aligner
retention and/or to apply force in
directions that cannot be
achieved by engaging with tooth
surfaces alone. | The aligner is an orthodontic
appliance intended for intra-oral
use. Individual devices will be
used between 20 – 22 hours per
day for a period ranging from
one to three weeks
The corrective forces to align
teeth are primarily generated by
the difference between the
starting tooth position and the
planned tooth position defined
by the tray. Features can be
added to the aligner that engage
with composite resin tooth
attachments to improve aligner
retention and/or to apply force in
directions that cannot be
achieved by engaging with tooth
surfaces alone. | The corrective forces to align
teeth are primarily generated by
the difference between the
starting tooth position and the
planned tooth position defined
by the tray. Features can be
added to the aligner that engage
with composite resin tooth
attachments to improve aligner
retention and/or to apply force in
directions that cannot be
achieved by engaging with tooth
surfaces alone. | Identical |
| Feature | Subject Device
ClearCorrect System | Primary Predicate Device
ClearCorrect System
(K113618) | Reference Device
Ormco™ SparkTM Aligner
System
(K182826) | Equivalence Discussion |
| Aligner
Material | Thermoplastic polyurethane-
polyester composite resin,
tradename ClearQuartz | Thermoplastic polyurethane film | Thermoplastic polyurethane-
polyester composite resin. | Equivalent
The Subject device has a
multilayer construction of
polyurethane and co-polyester
resins. The Reference Device
also has a multilayer
construction of polyurethane and
co-polyester resins. |
| Retainer
Material | 0.030" rigid polyurethane film | 0.030" rigid polyurethane film | Not relevant | Identical
The Retainer of the ClearCorrect
System is unchanged from the
previously cleared device. |
| Engager
Template
Material | 0.5 mm (0.02") rigid PETG film | 0.5 mm (0.02") rigid PETG film | Not relevant | Identical
The Engager Template of the
ClearCorrect System is
unchanged from the previously
cleared device. |
| Sterilization | Provided in non-sterile
condition. Not intended to be
sterilized before use. | Provided in non-sterile
condition. Not intended to be
sterilized before use. | Not relevant | Identical
The status of the Subject devices
is identical to that of the Primary
Predicate devices. |
| Singe Use/
Reuse | Repeated use by a single patient | Repeated use by a single patient | Repeated use by a single patient | Identical
The use profile of the Subject
devices is identical to that of the
Primary Predicate devices. |
| Packaging | Primary: LDPE bag containing
one or two appliances as defined
by the prescribed treatment plan.
Secondary: 20 pt C1S SBS
paperboard box | Primary: LDPE bag containing
one or two appliances as defined
by the prescribed treatment plan.
Secondary: 20 pt C1S SBS
paperboard box | Not relevant | Identical
The packaging for the Subject
devices is identical to that of the
Primary Predicate devices. |
7