(2 days)
No
The summary mentions "software-generated sequence of intermediate states" but provides no details or keywords (AI, ML, DNN, training set, test set, performance metrics like AUC, sensitivity, specificity) that would indicate the use of AI/ML in this software. The focus is on manufacturing validation and material biocompatibility.
Yes
The device is described as aligning teeth during orthodontic treatment of tooth malocclusion and incrementally moving teeth using continuous gentle force, which are therapeutic actions aimed at correcting a medical condition.
No
The device, K Clear aligners, is described as aligning teeth during orthodontic treatment by incrementally moving them. Its intended use focuses on treatment (tooth alignment) rather than diagnosing a condition. There is no mention of it being used to detect, monitor, or determine the presence or absence of a disease or condition.
No
The device description explicitly states that the device is a series of "clear plastic removable aligners," which are physical hardware components. The software is used to generate the sequence of intermediate states for these physical aligners.
Based on the provided information, the K Clear aligners are not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This information is used for diagnosis, monitoring, or screening.
- K Clear Function: K Clear aligners are physical devices that are placed directly in the mouth to apply force to teeth and move them. They do not analyze any biological specimens.
- Intended Use: The intended use is for the "alignment of teeth during orthodontic treatment," which is a mechanical process, not a diagnostic one based on analyzing biological samples.
- Device Description: The description focuses on the physical nature of the aligners and their mechanism of action (applying force to teeth).
- Lack of IVD-related information: The document does not mention any analysis of biological samples, diagnostic purposes, or any of the typical components or processes associated with IVDs (like reagents, assays, or specimen handling).
Therefore, K Clear aligners fall under the category of a medical device used for treatment, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
Product codes
NXC
Device Description
The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
teeth
Indicated Patient Age Range
patients with permanent dentition (i.e., all second molars).
Intended User / Care Setting
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)
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for K Clear aligners. A qualitation was performed to demonstrate the device is manufactured and performs as intended. A shelf-life/aging study was performed to support device labeling.
Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The following biological tests were performed:
Biological Endpoint: Cytotoxicity, Relevant Standard: ISO 10993-5:2009
Biological Endpoint: Sensitization, Relevant Standard: ISO 10993-10:2010
Biological Endpoint: Irritation, Relevant Standard: ISO 10993-10:2010
Biological Endpoint: Sub-chronic toxicity, Relevant Standard: ISO 10993-11:2017
Biological Endpoint: Genotoxicity, Relevant Standard: ISO 10993-3:2014
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical or animal testing data is included in this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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 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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 16, 2022
K Line Europe GmbH % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K220726
Trade/Device Name: K Clear Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic plastic bracket Regulatory Class: Class II Product Code: NXC Dated: March 11, 2022 Received: March 14, 2022
Dear Prithul Bom:
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.
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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about 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) K 220726
Device Name
K Clear
Indications for Use (Describe)
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
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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510(k) Summa K Line Europe, GmbH K Clear 2/2/2022
ADMINISTRATIVE INFORMATION
| Manufacturer Name | K Line Europe, GmbH
Niederrheinstraße 16
40474 Dusseldorf, Germany | |
|---------------------------------------|--------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| | Telephone: | +49 211 93896976 |
| | Official Contact: | Sherif Kandil, CEO |
| | Email: | sherif@clearxaligners.com |
| DEVICE NAME AND CLASSIFICATION | | |
| Trade/Proprietary Name: | | K Clear |
| Common Name: | | Aligners, sequential |
| Classification Name: | | Orthodontic Plastic Bracket |
| Classification Regulations: | | 21 CFR 872.5470 |
| Device Class: | | Class II |
| Product Code: | | NXC |
| Review Panel: | | Dental Products Panel |
| Reviewing Branch: | | Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices (OHT1B)
Dental Devices (DHT1B) |
PREDICATE DEVICE INFORMATION
The devices within this submission are substantially equivalent in indications, intended use and design principles to the following predicate and reference devices:
| 510(k) | Predicate Device Name | Company Name |
|---|---|---|
| K212660 | Smylio Invisible Clear Aligners | Smylio, Inc |
DEVICE DESCRIPTION
The K Line K Clear aligners are a series of prescription-only clear plastic removable aligners intended to incrementally move a patient's teeth from an initial position to a different end position using a softwaregenerated sequence of intermediate states. K Clear sequentially reposition teeth by way of continuous gentle force.
The technology and overall process is identical to that used by the Predicate device, Smylio Invisible Clear Aligners (K212660) and other sequential aligner systems currently being legally marketed.
INDICATIONS FOR USE/INTENDED USE
K Clear aligners are indicated for the alignment of teeth during orthodontic treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars).
4
EQUIVALENCE TO MARKETED DEVICE
Overall, the Subject device is substantially equivalent to the Predicate device with respect to Indications for Use and technological principles. The Comparison table below compares parameters and characteristics of the Subject device and Predicate/reference devices.
| Parameter | Subject Device | Predicate Device | Comparison |
|---|---|---|---|
| K Clear | |||
| K Line Europe, GmbH | Smylio Invisible Clear Aligners | ||
| Smylio, Inc | |||
| K212660 | |||
| Regulation # | 21 CFR 872.5470 | 21 CFR 872.5470 | Same |
| Classification Name | Orthodontic Plastic Bracket | Orthodontic Plastic Bracket | Same |
| Product Code | NXC | NXC | Same |
| Classification | Class II | Class II | Same |
| Indications for | |||
| Use/Intended Use | K Clear aligners are indicated for the alignment of teeth | ||
| during orthodontic treatment of tooth malocclusion in | |||
| patients with permanent dentition (i.e., all second | |||
| molars). | The Smylio Invisible Clear Aligners are indicated for | ||
| the alignment of teeth during orthodontic treatment | |||
| of tooth malocclusion. | Highly Similar | ||
| Intended Population | Individuals with permanent dentition (all second molars). | Not specified. | Similar |
| Mode of action | Continuous gentle force applied to teeth following the | ||
| prescribed and approved treatment plan to achieve | |||
| orthodontic movement. | Continuous gentle force applied to teeth following the | ||
| prescribed and approved treatment plan to achieve | |||
| orthodontic movement. | Same | ||
| Method of use | Each aligner is worn by the patient for 20-22 hours a day | ||
| and are to be removed for eating and cleaning. Aligners | |||
| are replaced by the next aligner in sequence as directed | |||
| by the dental health professional. | Each aligner is worn by the patient for 20-22 hours a | ||
| day and are to be removed for eating and cleaning. | |||
| Aligners are replaced by the next aligner in sequence | |||
| as directed by the dental health professional. | Same | ||
| Material | Thermoplastic polyurethane-polyester composite resin | Thermoplastic polyurethane-polyester composite resin | Same |
| Appliance Application | Patient removable | Patient removable | Same |
| Design | Image: Clear aligner | Image: Clear aligner | Same |
| Biocompatible | Yes | Yes | Same |
| OTC or Rx | Rx | Rx | Same |
| Sterile | Non-sterile | Non-sterile | Same |
Predicate Device Comparison Table
The wording of the Indications for Use of the Subject device is highly similar to that of the Predicate device, differing slightly in wording and device name. The Predicate device Indications for Use statement does not include a limitation on patient population and is inclusive of the intended population of the Subject device. The intended use of both devices to treat tooth malocclusion is the same for the Subject and Predicate devices.
TECHNOLOGICAL CHARACTERISTICS
Orthodontic tooth movement occurs through forces applied to the teeth by the appliance as each tooth follows the predetermined displacement based on a dental health professional's prescription. The Subject device mode of action, method of use and sterilization status are the same as the Predicate device.
The Subject and Predicate devices are both fabricated of non-sterile, biocompatible thermoplastic polyurethane-polyester composite resin material. The Subject device mode of action and method of use are the same as the Predicate device and supports a determination of substantial equivalence.
5
PERFORMANCE DATA
Due to the difficulty in evaluating this type of dental device in a laboratory environment, no direct performance bench testing of the aligners was performed. The use of thermoplastic materials for sequential aligners intended to treat malocclusions have been well documented in scientific literature regarding incremental tooth moving forces.
A manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing process for K Clear aligners. A qualitation was performed to demonstrate the device is manufactured and performs as intended. A shelf-life/aging study was performed to support device labeling.
Biocompatibility evaluation and testing for the aligner material was conducted in accordance with International Standard ISO 10993-1, "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process".
The following biological tests were performed:
| Biological Endpoint | Relevant Standard |
|---|---|
| Cytotoxicity | ISO 10993-5:2009 |
| Sensitization | ISO 10993-10:2010 |
| Irritation | ISO 10993-10:2010 |
| Sub-chronic toxicity | ISO 10993-11:2017 |
| Genotoxicity | ISO 10993-3:2014 |
The performance of sequential aligners in the clinical environment has been well established since the first such devices were cleared by the FDA in 1998 under product code NXC. No clinical or animal testing data is included in this submission.
CONCLUSION
Overall, the Indications for Use statement for the Subject and Predicate devices is highly similar.
Overall, the Technological Characteristics, Materials, Prescription Use and Non-sterile status of the Subject device are the same or highly similar to the Predicate device. The use of Software to produce the Subject and Predicate devices is the same. Minor differences between the Subject and Predicate devices were mitigated through performance testing of the Subject device.
Overall, the K Line K Clear aligners are substantially equivalent to the Predicate device.