(260 days)
No
The description focuses on the physical properties and mechanical action of the aligners, with no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
Explanation: The device is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion, directly addressing a medical condition or ailment.
No
The device is an orthodontic appliance used for tooth alignment, which is a treatment, not a diagnostic, function.
No
The device description clearly states that the device is a "sequential series of clear thermoformed orthodontic appliances," which are physical, intra-oral devices. The summary also includes performance studies related to the physical properties of these appliances (e.g., tensile, flexural, impact testing). While software is mentioned in the context of development (IEC 62304), the core medical device is a physical appliance, not software alone.
Based on the provided information, the ClearCorrect System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "alignment of teeth during orthodontic treatment of tooth malocclusion." This is a therapeutic purpose, not a diagnostic one. IVDs are used to examine specimens from the human body to provide information for diagnosis, monitoring, or screening.
- Device Description: The device is a physical appliance worn in the mouth to physically move teeth. It does not analyze biological samples.
- Input: While it uses scans of impressions or intra-oral scans, these are inputs for designing and manufacturing the physical appliance, not for analyzing biological markers.
- Anatomical Site: The device acts directly on the teeth, which are part of the patient's anatomy, not a specimen taken from the patient.
The ClearCorrect System is an orthodontic appliance, which falls under the category of medical devices used for treatment.
N/A
Intended Use / Indications for Use
The Clear Correct System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.
Product codes
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 forces to align teeth are primarily generated by the difference between the starting tooth position and the planned tooth position defined by the appliance. Features can be added to the aligner that engage with composite resin tooth attachments to improve aligner retention and/or to apply force s in directions that cannot be achieved by engaging with tooth surfaces alone.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
scan of a PVS impression or the output of an intra-oral scanner
Anatomical Site
teeth, oral anatomy
Indicated Patient Age Range
Not Found
Intended User / Care Setting
ClearCorrect technicians, dental practitioner, clinician
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)
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)
K143630, Invisalign System, Align Technologies
Reference Device(s)
K210320, ClearCorrect System, ClearCorrect, LLC, K203737, Spark Clear Aligner System, Ormco Corporation
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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October 5, 2022
ClearCorrect, LLC Christopher Klaczyk VP, Head of Regulatory Affairs 21 Cypress Boulevard, Suite 1010 Round Rock, Texas 78665
Re: K220140
Trade/Device Name: ClearCorrect System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: September 8, 2022 Received: September 9, 2022
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
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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) K220140
Device Name ClearCorrect System
Indications for Use (Describe)
The Clear Correct System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion.
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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| 510(k) Summary | K220140 |
|---|---|
| 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: | October 1, 2022 |
| 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): | K143630, Invisalign System, Align Technologies |
| Reference Device(s): | K210320, ClearCorrect System, ClearCorrect, LLC |
| K203737, Spark Clear Aligner System, Ormco Corporation | |
| 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 | |
| forces to align teeth are primarily generated by the difference | |
| between the starting tooth position and the planned tooth | |
| position defined by the appliance. Features can be added to | |
| the aligner that engage with composite resin tooth | |
| attachments to improve aligner retention and/or to apply force s | |
| in directions that cannot be achieved by engaging with tooth | |
| surfaces alone. | |
| Indications For Use: | The ClearCorrect System is indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion. |
| Materials: | The ClearCorrect aligners are produced from multi-layer polymer film having the trade name ClearQuartz™. The film consists of one layer of elastomeric polyurethane sandwiched between two layers of rigid co-polyester. |
| Technological Characteristics: | A comparison of the indications and relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. |
| Performance Data: | 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: | The Indications for Use and the technological characteristics of the subject device are largely the same as the primary predicate device. The material of construction and the treatment planning software are identical to the reference predicate device. 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
Invisalign System
(K143630) | Reference Device
ClearCorrect System
(K210320) | Reference Device
Spark Clear Aligner Sys.
(K203737) | Equivalence Discussion |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications
for Use | The ClearCorrect System is
indicated for the alignment
of teeth during orthodontic
treatment of tooth
malocclusion. | The Invisalign System is
indicated for the alignment
of teeth during orthodontic
treatment of malocclusion. | 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 Spark™ Clear Aligner
System is indicated for the
alignment of teeth during
orthodontic treatment of
malocclusion. | Equivalent
The indication for the
Subject Device is a subset
of the indications for the
Primary Predicate Device.
And the K203737
Reference Predicate Device. |
| 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 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. | 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. | 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. | Equivalent
The mode of operation of
the Subject Device is
largely equivalent to that of
the Primary Predicate
Device and is identical to
that of the K210320
Reference Predicate Device. |
| Feature | Subject Device
ClearCorrect System | Primary Predicate Device
Invisalign System
(K143630) | Reference Device
ClearCorrect System
(K210320) | Reference Device
Spark Clear Aligner Sys.
(K203737) | Equivalence Discussion |
| Aligner
Material | Thermoplastic
polyurethane-polyester
composite resin, tradename
ClearQuartz | Thermoplastic polymer | Thermoplastic
polyurethane-polyester
composite resin, tradename
ClearQuartz | Thermoplastic
polyurethane-polyester
composite resin, tradename
TruGEN | Identical
The Subject Aligner
material is identical to that
of the Reference Devices
per K210320 and K203737. |
| 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. | Provided in non-sterile
condition. Not intended to
be sterilized before use. | Provided in non-sterile
condition. Not intended to
be sterilized before use. | Identical
The status of the Subject
devices is identical to that
of the Reference Device per
K210320. |
| Singe Use/
Reuse | Repeated use by a single
patient | 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 Reference
Device per K210320. |
| Packaging | Primary: LDPE bag
containing one or two
appliances as defined by the
prescribed treatment plan.
Secondary: 20 pt C1S SBS
paperboard box | Unknown | Primary: LDPE bag
containing one or two
appliances as defined by the
prescribed treatment plan.
Secondary: 20 pt C1S SBS
paperboard box | Unknown | Identical
The packaging for the
Subject devices is identical
to that of the Reference
Device per K210320. |
| Feature | Subject Device
ClearCorrect System | Primary Predicate Device
Invisalign System
(K143630) | Reference Device
ClearCorrect System
(K210320) | Reference Device
Spark Clear Aligner Sys.
(K203737) | Equivalence Discussion |
| Treatment
Planning
Software
Description | ClearCorrect technicians
using the ClearCorrect Cut
and Stage software use a
scan of a PVS impression or
the output of an intra-oral
scanner of the patient's
untreated oral anatomy and
the prescription details to
derive the desired final
patient tooth positions.
Using this desired state, the
software interprets a series
of intermediate states that
adhere to defined maximum
tooth motions and clinician
instructions. The technician
further refines these
intermediate states
manually as necessary to
facilitate the desired
outcome. 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 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 | ClearCorrect technicians
using the ClearCorrect Cut
and Stage software use a
scan of a PVS impression or
the output of an intra-oral
scanner of the patient's
untreated oral anatomy and
the prescription details to
derive the desired final
patient tooth positions.
Using this desired state, the
software interprets a series
of intermediate states that
adhere to defined maximum
tooth motions and clinician
instructions. The technician
further refines these
intermediate states
manually as necessary to
facilitate the desired
outcome. 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 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. | Identical
The software used by
technicians internal to
ClearCorrect is identical to
that used with the Reference
Predicate Device.
The software is functionally
equivalent to the software
of the Primary Predicate. |
| Feature | Subject Device
ClearCorrect System | Primary Predicate Device
Invisalign System
(K143630) | Reference Device
ClearCorrect System
(K210320) | Reference Device
Spark Clear Aligner Sys.
(K203737) | Equivalence Discussion |
| Clinician
Interface
Software
Description | The ClearCorrect Doctor
Portal is used by the
clinician to initiate new
treatment cases coordinating
the provision of dental
records, the prescription,
and any other treatment
instructions. Doctor Portal
also allows the clinician to
manage existing cases and
address any actions
associated with those cases.
The ClearCorrect
ClearPilot™ allows the
clinician to view, comment
and approve the orthodontic
treatment plan. ClearPilot
also allows the clinician to
monitor treatment progress
against the plan and to share
the plan with the patient. | ClinCheck Software is an
electronic prescription form
and process used to depict,
edit, view, monitor and
approve an orthodontic
treatment plan.
Treatment Plan File:
The plan downloads to
other computing devices
(e.g., tablets)
The plan is deleted upon
exiting application | The ClearCorrect Doctor
Portal is used by the
clinician to initiate new
treatment cases coordinating
the provision of dental
records, the prescription,
and any other treatment
instructions. Doctor Portal
also allows the clinician to
manage existing cases and
address any actions
associated with those cases.
The ClearCorrect ClearPilot
allows the clinician to view,
comment and approve the
orthodontic treatment plan.
ClearPilot also allows the
clinician to monitor
treatment progress against
the plan and to share the
plan with the patient. | Unknown | Equivalent
The combination of Subject
device clinician interface
software provides the same
functionality as the Primary
Predicate Device ClinCheck
software and is identical to
that of the Reference
Device. |
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