(90 days)
No
The description focuses on standard manufacturing processes based on clinician-designed treatment plans and scanned models, with no mention of AI/ML in the design or manufacturing process.
Yes
The device is a system of aligners that gradually moves teeth to correct misalignment and malocclusion, which is a therapeutic intervention.
No
Explanation: The device is described as a system for aligning teeth through orthodontic treatment using clear aligners. Its purpose is to correct misalignment and malocclusion, which is a therapeutic rather than a diagnostic function. The description focuses on how the aligners are manufactured and how they gradually move teeth, not on identifying or detecting a medical condition.
No
The device description clearly states that the system contains "clear plastic removable aligners" which are physical, manufactured components. While software is used in the process (scanning models, producing digital files), the final medical device delivered to the patient is a physical product, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The Custom Clear Aligner System is a physical device used to mechanically move teeth for orthodontic treatment. It does not analyze biological samples or provide diagnostic information about a patient's health status.
- Intended Use: The intended use is "alignment teeth through orthodontic treatment of misalignment and malocclusion." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The description details the fabrication of physical aligners based on impressions and digital models. It does not involve any analysis of biological samples.
- Input: The input is "Scans of models from impressions," which are physical representations of the teeth, not biological samples.
Therefore, the Custom Clear Aligner 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 Custom Clear Aligner System is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
The Custom Clear Aligner System is indicated for use in the alignment of permanent teeth through orthodontic treatment of misalignment and malocclusion.
Product codes
NXC
Device Description
Derby Dental Laboratory's Custom Clear Aligner System contains a series of doctor-approved, customized processed, clear plastic removable aligners that gradually move the patient's teeth in small increments from their original misalignment to a more optimal, aligned and treated stated.
Derby Dental Laboratory manufactures the customized aligners based on standard impressions sent to the company by the prescribing dentist or orthodontist. These are made after the clinician has assessed the patient's teeth, designed a treatment plan, and taken the impressions.
Derby Dental manufactures models from the impressions and then scans the models using standard validated software. The digital files are used to produce the aligner series using standard thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is commonly used in many dental appliances.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
permanent teeth
Indicated Patient Age Range
Not Found
Intended User / Care Setting
prescribing dentist or orthodontist, dental practitioner
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)
Device Testing Biocompatibility Contact of the device to the patient's oral tissue requires the aligner material to be biocompatible. The thermoplastic polyurethane has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: Part 3 (Bacterial Mutagenicity - Ames Assay) Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Oral Mucosa Irritation), Part 10 (Maximization for Delayed-Type Hypersensitivity), Part 11 (Subacute Systemic Toxicity) The testing has shown that the material is biocompatible for the use intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym followed by the words "U.S. FOOD & DRUG ADMINISTRATION" on the right. The FDA part of the logo is in blue, with the acronym in a larger font size than the rest of the text.
March 13, 2018
Derby Dental Laboratory % Patsy Trisler Regulatory Consultant Trisler Consulting 5600 Wisconsin Ave, #509 Chevy Chase, Maryland 20815
Re: K173785
Trade/Device Name: Custom Clear Aligner System Regulation Number: 21 CFR 872.5470 Regulation Name: Orthodontic Plastic Bracket Regulatory Class: Class II Product Code: NXC Dated: December 12, 2017 Received: December 13, 2017
Dear Patsy Trisler:
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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Andrew I. Steen -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K173785
Device Name
Custom Clear Aligner System
Indications for Use (Describe)
The Custom Clear Aligner System is indicated for use in the alignment teeth through orthodontic treatment of misalignment and 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 K173785
| Submitter Name: | Derby Dental Laboratory, Inc. |
|---|---|
| Submitter Address: | 3332 Gilmore Industrial Blvd |
| Louisville, KY 40213 | |
| Phone Number: | 800-745-6718 |
| Contact Person: | Mr. Reed Nunnally |
| Date Prepared: | March 13, 2018 |
| Device Trade Name: | Custom Clear Aligner System |
| Common Name | Aligner, Sequential |
| Classification Name | |
| Number | Orthodontic Plastic Bracket |
| 21 CFR 872.5470 | |
| Product Code | NXC |
| Regulatory Class | 2 |
| Primary Predicate | |
| Device: | K113618, ClearCorrect System, ClearCorrect LLC |
| Reference Predicate | |
| Device: | K152086, 3Shape Ortho System (3Shape A/S) |
| Statement of | |
| Intended Use | The Custom Clear Aligner System is indicated for use in the |
| alignment of permanent teeth through orthodontic treatment of | |
| misalignment and malocclusion. | |
| Device Description | |
| and Summary of | |
| Technological | |
| Characteristics | Derby Dental Laboratory's Custom Clear Aligner System contains |
| a series of doctor-approved, customized processed, clear plastic | |
| removable aligners that gradually move the patient's teeth in small | |
| increments from their original misalignment to a more optimal, | |
| aligned and treated stated. |
Derby Dental Laboratory manufactures the customized aligners
based on standard impressions sent to the company by the
prescribing dentist or orthodontist. These are made after the
clinician has assessed the patient's teeth, designed a treatment
plan, and taken the impressions.
Derby Dental manufactures models from the impressions and
then scans the models using standard validated software. The
digital files are used to produce the aligner series using standard
thermoplastic polyurethane.
The thermoplastic material used for fabrication of the aligners is
commonly used in many dental appliances. |
4
Mechanism of Action In the same manner as the predicate device, each aligner exerts gentle force to achieve progressive realignment of the teeth until the final correction has been attained. This is based on the treatment plan and proceeds over time. Device Testing Biocompatibility Contact of the device to the patient's oral tissue requires the aligner material to be biocompatible. The thermoplastic polyurethane has been tested according to Good Laboratory Practices for its biocompatibility according to ISO 10993, as follows: Part 3 (Bacterial Mutagenicity - Ames Assay) Part 5 (Cytotoxicity Elution - MEM), Part 10 (Intracutaneous/Intradermal) Reactivity), Part 10 (Oral Mucosa Irritation), Part 10 (Maximization for Delayed-Type Hypersensitivity), Part 11 (Subacute Systemic Toxicity) The testing has shown that the material is biocompatible for the use intended. Animal | Human Testing No animal or human testing were required for this product
because it is composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device.
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| Comparison to
Predicate Device: | Trade Name: | Custom Clear Aligner
System | ClearCorrect System |
|------------------------------------|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 510(k) Number | K173785 | K113618 |
| | Manufacturer | Derby Dental Laboratory, Inc. | ClearCorrect, LLC |
| | Classification
&
Product
Code | 21 CFR
852.5470
NXC
2 | 21 CFR
852.5470
NXC
2 |
| | Intended Use | The Custom Clear Aligner
System is indicated for use
in the alignment of
permanent teeth through
orthodontic treatment of
misalignment and
malocclusion. | The ClearCorrect System is
indicated for the treatment
of tooth malocclusion in
patients with permanent
dentition (i.e. all second
molars). The Clear Correct
System positions teeth by
way of continuous gentle |
| | Mode of Action | Alignment of teeth by
application of continuous
gentle force, by sequential
use of preformed plastic
trays. | Alignment of teeth by
application of continuous
gentle force, by sequential
use of preformed plastic
trays. |
| | Method of Use | Each preformed plastic
tray is worn by the patient
as prescribed by the
dental practitioner, usually
a few weeks prior to
using the next sequential
aligner tray. | Each preformed plastic
tray is worn by the
patient as prescribed by
the dental practitioner,
usually a few weeks
prior to using the next
sequential aligner tray. |
| | Material | Thin
thermoformed
polyurethane | Thin
thermoformed
polyurethane |
| | Biocompatible | Yes | Yes |
| | OTC or Rx | Rx | Rx |
| | Software Use | Yes | Yes |
| | Sterile | No | No |
The intended use of the Custom Clear Aligner System is similar to that of the primary predicate device as they are both intended for correcting dental malocclusion in patients with permanent dentition.
It has a similar technological principle, and the device characteristics are similar to the predicate device. The mode of operation and the material used to fabricate the aligner trays is the same as the predicate device. There are no notable differences comparing Derby Dental's Custom Clear Aligner System to the predicate ClearCorrect System.
Substantial Thus, based on the above it can be concluded that Derby Dental Equivalence Laboratory's Custom Clear Aligner System is substantially Conclusion equivalent to the predicate device.