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510(k) Data Aggregation
(90 days)
Custom Clear Aligner System
The Custom Clear Aligner System is indicated for use in the alignment teeth through orthodontic treatment of misalignment and malocclusion.
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.
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.
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