Who is the manufacturer of Custom Clear Aligner System?

Derby Dental Laboratory filed the 510(k) submission for Custom Clear Aligner System (K173785).

What is the FDA product code for Custom Clear Aligner System?

NXC. It is classified under 21 CFR 872.5470 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Custom Clear Aligner System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Custom Clear Aligner System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Custom Clear Aligner System

K173785 · Derby Dental Laboratory · NXC · Mar 13, 2018 · Dental

Device Facts

Record ID	K173785
Device Name	Custom Clear Aligner System
Applicant	Derby Dental Laboratory
Product Code	NXC · Dental
Decision Date	Mar 13, 2018
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5470
Device Class	Class 2
Attributes	Therapeutic

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 Story

Custom Clear Aligner System consists of series of clear, removable thermoplastic polyurethane aligners; used for orthodontic tooth movement. Clinician takes patient impressions; laboratory creates physical models; models scanned using validated software to generate digital files; aligners fabricated from digital files. Patient wears sequential aligners as prescribed by dentist/orthodontist; aligners exert gentle, continuous force to move teeth incrementally. Used in dental clinic/office setting; operated by dental professionals. Output is physical aligner tray; clinical decision-making based on clinician-designed treatment plan. Benefits patient by providing aesthetic, removable alternative to traditional braces for correcting malocclusion.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence established through bench testing, including biocompatibility assessment per ISO 10993 (Ames Assay, Cytotoxicity, Intracutaneous Reactivity, Oral Mucosa Irritation, Maximization for Delayed-Type Hypersensitivity, and Subacute Systemic Toxicity).

Technological Characteristics

Material: Thermoplastic polyurethane. Sensing/Actuation: Mechanical force via sequential thermoformed trays. Connectivity: Digital scanning of physical models. Software: Validated software for digital model processing. Sterilization: Non-sterile. Form factor: Custom-fit clear plastic aligners.

Indications for Use

Indicated for alignment of permanent teeth in patients with misalignment and malocclusion requiring orthodontic treatment.

Regulatory Classification

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.

Predicate Devices

ClearCorrect System (K113618)

Reference Devices

3Shape Ortho System (K152086)

Related Devices

K211510 — uLab Systems Dental Aligner Kit · Ulab Systems, Inc. · Feb 24, 2022
K223454 — Custom-made Invisible Aligners · Zhejiang Yinchili Medical Technology Co., Ltd. · Apr 17, 2023
K113618 — CLEARCORRECT SYSTEM · Clearcorrect, Inc. · Mar 19, 2012
K190394 — SunClear Aligner system · Sun Dental Laboratories, LLC · Dec 16, 2019
K191823 — Clear-Aligners · Cdb Corporation · Dec 20, 2019

Submission Summary (Full Text)

{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); {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## 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. {5}------------------------------------------------ | 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.