(131 days)
No
The description details a process using standard dental software (3Shape A/S Ortho System) for treatment planning and model generation based on a dental professional's prescription. There is no mention of AI or ML being used in the planning or manufacturing process.
Yes
The device is indicated for the treatment of tooth malocclusion, and it directly positions teeth by applying continuous force to facilitate movement to a desired position, which aligns with the definition of a therapeutic device.
No
The device is an aligner used for the treatment of tooth malocclusion, not for diagnosing a condition.
No
The device description clearly states that the Redline Aligner is a series of thermoformed plastic aligners, which are physical hardware components. While software is used in the design and manufacturing process, the final device delivered to the patient is a physical product.
Based on the provided information, the Redline Aligner 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.
- Redline Aligner's Function: The Redline Aligner is a physical device worn in the mouth to mechanically move teeth. It does not analyze biological specimens or provide diagnostic information based on such analysis.
- Intended Use: The intended use is for the "treatment of tooth malocclusion," which is a physical correction, not a diagnostic process.
- Device Description: The description details the physical creation and use of the aligners for tooth movement.
- Input: The input is a mold or digital impression of the teeth, which is a physical representation, not a biological specimen for analysis.
The Redline Aligner falls under the category of a medical device used for treatment, specifically in orthodontics.
N/A
Intended Use / Indications for Use
The Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner positions teeth by way of continuous gentle force.
Product codes (comma separated list FDA assigned to the subject device)
NXC
Device Description
The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.
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. 3Shape A/S Ortho System 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 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental 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
Anatomical Site
Mouth; mucosa membranes
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)
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:
An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Redline 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. Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. There were no statistical difference in the values measured from any of the groups. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation demonstrate all the aligners including in the study passed and were deemed an excellent fit.
Biocompatibility testing:
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". Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Redline Aligners.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process.
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.
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.
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA acronym is in a blue box, and the full name is in a sans-serif font.
February 9, 2022
Johns Dental Laboratories % Na Zhang Project Manager Evo820, LLC 1 Bay Street Rancho Mission Viejo, California 92694
Re: K213297
Trade/Device Name: Redline Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: January 19, 2022 Received: January 20, 2022
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 (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) K213297
Device Name Redline Aligner
Indications for Use (Describe)
The Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner 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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K213297 510(k) Summary
SUBMITTER
| Date Prepared: | 02/08/2022 |
|---|---|
| Submitter: | Johns Dental Laboratories |
| 423 S.13th ST | |
| Terre Haute, Indiana, 47807 | |
| United States of America | |
| Official Contact: | Mani Buis |
| Controller | |
| Tel:800-457-0504 | |
| Fax:812-234-4464 | |
| Email: marnih@johnsdental.com |
DEVICE
| Trade/Proprietary Name: | Redline |
|---|---|
| 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
| Predicate Device: | K172765 | Smart Moves Complete | Great Lakes Orthodontics Ltd |
|---|---|---|---|
| Reference Device: | K191838 | ClearForm Aligners | Motor City Lab Works |
DEVICE DESCRIPTION
The Redline Aligner is a series of clear, light weight thermoformed plastic aligners designed to be worn in sequence to facilitate the movement to the teeth to the final desired position. The sequential aligners introduce incremental movements that move teeth by way of gentle continuous force. The aligners are to be worn 20-22 hours a day for an average of 2 weeks per aligner or as directed by the clinician and are to be removed only for eating and for cleaning.
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
4
patient's dentition. 3Shape A/S Ortho System 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 3Shape A/S Ortho System, is used to generate standard format 3D files which are used to physically produce each model/mold in the treatment plan for aligner fabrication. Johns dental 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 Redline Aligner is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e. all second molars). The Redline Aligner positions 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 the predicate devices shown above. Below is a summary table comparing the subjective device with the primary predicate and an additional reference device.
| Features | Submission Device | Predicate Device | Reference
Device |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacture | Johns Dental
Laboratories | Great Lake
Orthodontics, Ltd. | Motor City Dental Lab |
| Trade Name | Redline | Smart Moves Complete | ClearForm Aligners |
| 510(k)
Number | K213297 | K172765 | K191838 |
| Regulation
Number | 21 CFR 872.5470 | 21 CFR 872.5470 | 21 CFR 872.5470 |
| Classifications | Class II | Class II | Class II |
| Product Code | NXC | NXC | NXC |
| Indications for
Use | The Redline Aligner is
indicated for the | Smart Moves Complete
is indicated for the | ClearForm Aligners are
indicated for the |
| | treatment of tooth
malocclusion in
patients with
permanent dentition
(i.e., all second
molars). The Redline
Aligner positions teeth
by way of continuous
gentle force. | treatment of tooth
malocclusion in
patients with permanent
dentition (i.e., all
second molars). Smart
Moves Complete
positions teeth by way
of continuous gentle
force. | alignment of teeth in
patients with permanent
dentition (i.e. all second
molars) during
orthodontic treatment of
malocclusions. The
aligners position teeth by
way of continuous gentle
forces |
| Mode of
Actions | 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. | 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. | Orthodontic movement
occurs through
continuous gentle forces
applied to the dentition
as each tooth follows the
programmed
displacement based on a
doctor's prescription. |
| Material | PETG, thermoplastic | $0.03"$ Thermoplastic
PETG | Essix thermoplastic |
| Biocompatible
Software | Yes
3Shape A/S Ortho
System 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
files to produce the
series of patient
specific aligners. | Yes
The Smart Moves
Complete 3-D software
uses a scan of a PVS
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 files to
produce the series of
patient specific
aligners. | Yes
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 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 patient specific aligners. |
| | | | models used to produce
thermoformed aligners. |
| Manufacture
Method | Thermoforming | Thermoforming | Thermoforming |
| Rx or OTC | Rx | Rx | Rx |
| Anatomy
location | Mouth; mucosa
membranes | Mouth; mucosa
membranes | N/A |
| Sterility | Non-sterile | Non-sterile | Non-sterile |
| Design | Image: clear aligner | Image: red aligner with text "smart moves complete" | Image: clear aligner |
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The intended use of the Redline Aligner is the same as the primary predicate device. They are both intended for correcting dental malocclusion patients with permanent dentition. It has similar technological characteristic and fabricated by a similar manufacturing process to the predicate device. The application of the device is in the same clinical manner as the predicate device. Therefore, the Redline 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 Redline 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 Redline Aligner is manufactured by 3Shape A/S Ortho System. It is a 510(k) clearance (K180941) software under product code PNN for intended use.
An internal manufacturing validation was performed to demonstrate the dimensional accuracy of the manufacturing for Redline 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.
Translational measurement were within 0.150mm (150microns) of the target input value, the predefined tolerance of the manufacturing process. There were no statistical difference in the values measured from any of the groups. The testing results are within the acceptance criteria to demonstrate dimensional accuracy. Additionally, the final aligner fitness evaluation demonstrate all the aligners including in the study passed and were deemed an excellent fit .
7
The biocompatibility evaluation and the determination that Redline Aligner and the predicate devices are composed of the same material, fabricated by the similar manufacturing processes, and are used in the same clinical application, which concludes that Redline Aligners are biocompatible for their 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".
Additional cytotoxicity testing according to ISO 10993-5:2009 was performed on the final manufactured Redline Aligners .
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 Redline aligners have equivalent indication and method of use to its primary and reference devices, therefore there was no clinical testing to support this device.
CONCLUSION
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 conclusion, the device is substantially equivalent based on a comparison of intended use, and technological characteristics, the device is safe and effective for its intended use.