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.

AI/ML Overview

This document describes the Custom Clear Aligner System from Derby Dental Laboratory.

Acceptance Criteria and Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a table format with performance metrics. Instead, the demonstration of substantial equivalence relies on the device being "composed of the same materials and has a similar design and method of manufacture/fabrication in comparison to the predicate device."

The primary predicate device is the ClearCorrect System (K113618) from ClearCorrect LLC.

The comparison table provided (page 5) highlights the similarities:

Feature	Custom Clear Aligner System	ClearCorrect System (Predicate)
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 force.
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 (Prescription Use)	Rx (Prescription Use)
Software Use	Yes	Yes
Sterile	No	No

Study Details:

The document explicitly states: "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."

Therefore, the following information is not applicable or not provided in this submission:

Sample size used for the test set and the data provenance: Not applicable as no human or animal testing was performed for this device.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. The device is a physical aligner system, not an AI-assisted diagnostic or treatment planning system for human readers.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a human/animal test set for this device. The "ground truth" for demonstrating equivalence largely relies on the known performance and safety of the predicate device.
The sample size for the training set: Not applicable as no new clinical training data was generated for the purpose of demonstrating equivalence for this device.
How the ground truth for the training set was established: Not applicable.

Biocompatibility Testing:

While no human or animal performance testing was required, biocompatibility testing was performed on the thermoplastic polyurethane material used for the aligners.

Tests Conducted: According to ISO 10993, the material underwent:
- 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)
Result: "The testing has shown that the material is biocompatible for the use intended."

Conclusion of Equivalence:

The submission concludes that the Custom Clear Aligner System is substantially equivalent to the predicate device (ClearCorrect System) due to similar intended use, technological principles, device characteristics, mode of operation, and material used.

Summary

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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 BlvdLouisville, 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 NameNumber	Orthodontic Plastic Bracket21 CFR 872.5470
Product Code	NXC
Regulatory Class	2
Primary PredicateDevice:	K113618, ClearCorrect System, ClearCorrect LLC
Reference PredicateDevice:	K152086, 3Shape Ortho System (3Shape A/S)
Statement ofIntended Use	The Custom Clear Aligner System is indicated for use in thealignment of permanent teeth through orthodontic treatment ofmisalignment and malocclusion.
Device Descriptionand Summary ofTechnologicalCharacteristics	Derby Dental Laboratory's Custom Clear Aligner System containsa series of doctor-approved, customized processed, clear plasticremovable aligners that gradually move the patient's teeth in smallincrements from their original misalignment to a more optimal,aligned and treated stated.Derby Dental Laboratory manufactures the customized alignersbased on standard impressions sent to the company by theprescribing dentist or orthodontist. These are made after theclinician has assessed the patient's teeth, designed a treatmentplan, and taken the impressions.Derby Dental manufactures models from the impressions andthen scans the models using standard validated software. Thedigital files are used to produce the aligner series using standardthermoplastic polyurethane.The thermoplastic material used for fabrication of the aligners iscommonly used in many dental appliances.

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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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Trade Name:	Custom Clear AlignerSystem	ClearCorrect System
510(k) Number	K173785	K113618
Manufacturer	Derby Dental Laboratory, Inc.	ClearCorrect, LLC
Classification# &ProductCode	21 CFR852.5470NXC2	21 CFR852.5470NXC2
Intended Use	The Custom Clear AlignerSystem is indicated for usein the alignment ofpermanent teeth throughorthodontic treatment ofmisalignment andmalocclusion.	The ClearCorrect System isindicated for the treatmentof tooth malocclusion inpatients with permanentdentition (i.e. all secondmolars). The Clear CorrectSystem positions teeth byway of continuous gentle
Mode of Action	Alignment of teeth byapplication of continuousgentle force, by sequentialuse of preformed plastictrays.	Alignment of teeth byapplication of continuousgentle force, by sequentialuse of preformed plastictrays.
Method of Use	Each preformed plastictray is worn by the patientas prescribed by thedental practitioner, usuallya few weeks prior tousing the next sequentialaligner tray.	Each preformed plastictray is worn by thepatient as prescribed bythe dental practitioner,usually a few weeksprior to using the nextsequential aligner tray.
Material	Thinthermoformedpolyurethane	Thinthermoformedpolyurethane
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.

Regulation Number and Section

§ 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.