(239 days)
The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion.
The Dentti System is a series of clear plastic aligners that are used to replace traditional orthodontic wires and brackets for the alignment of maloccluded or misaligned teeth. This series of aligners moves the teeth gently, and in small increments, from their original to their final treated position for improved dental alignment. The Dentist will provide a scan of the patient's current dentition along with instructions for the treatment plan. The dental laboratory will generate a series of 3-D computer-designs of the modified dentition that the Dentist will review. Upon approval, the models will be generated and used to fabricate the sequential aligners according to the dentist's prescription. The aligners are fabricated from commonly used thermoformed polyurethane plastic material. The aligners are sent back to the Dentist, who then provides them to the patient, confirming the fit and design. Over a period of months, additional aligners will be provided sequentially to the patient by the Dentist to gradually move the selected teeth to the desired position. The Dentist will monitor the treatment from the moment the first aligner is delivered to when treatment is completed. The aligners are held in place by pressure and can be removed by the patient at any time. This technology is essentially identical to that used by a number of sequential alignment systems, including the predicate devices.
This document is a 510(k) premarket notification for the Dentti System, an orthodontic plastic bracket (sequential aligner). The FDA has determined the device is substantially equivalent to legally marketed predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the traditional sense of performance metrics with specific thresholds. Instead, the submission relies on demonstrating substantial equivalence to predicate devices. The "performance" assessment is based on a comparison of characteristics, materials, and intended use, rather than specific quantitative performance studies with predefined acceptance limits.
The table below summarizes the comparative information provided in the "Substantial Equivalence Comparison" on page 6 of the document. The "Reported Device Performance" here refers to the characteristics of the Dentti System as presented in comparison to its predicates.
| Characteristic | Acceptance Criteria (Implied by Predicate Comparison) | Reported Device Performance (Dentti System - K151965) |
|---|---|---|
| Device Classification Name | Orthodontic Plastic Bracket (Sequential Aligners) | Orthodontic Plastic Bracket (Sequential Aligners) |
| Regulation Number | 872.5470 | 872.5470 |
| Product Code | NXC | NXC |
| Indications for Use | Alignment of teeth during orthodontic treatment of malocclusion (similar to predicates, though Clear Image has more narrow scope of "minor discrepancies in the alignment of maloccluded anterior teeth") | "The Dentti System is indicated for the alignment of teeth during orthodontic treatment of malocclusion." |
| Mechanism of Action | Basic mechanics follows same principles of conventional orthodontics; aligners apply force on teeth to produce tipping, rotation, extrusion, and intrusion forces. | Basic mechanics follows the same principles of conventional orthodontics. The aligners apply a force on the tooth. Therefore, the Sequential aligners can produce tipping, rotation, extrusion and intrusion forces. |
| Software | Yes (for most comparable predicates like Invisalign and ClearCorrect) | Yes |
| Materials that Contact the Patient | Commonly used thermoformed plastic material; specifically, Thermoformed Polyurethane (Zendura) as used in ClearCorrect. | Commonly used thermoformed plastic material - Thermoformed Polyurethane (Zendura) |
| Aligner Design | Covers buccal, lingual and occlusal surfaces of the teeth like a custom tray; may include space for attachments to aid retention. | Covers buccal, lingual and occlusal surfaces of the teeth like a custom tray. When using the modified tray design, space is left for so thin attachments could be affixed to the teeth to aid retention. |
| Single Use | Yes - Multiple use by the same patient (for all predicates) | Yes - Multiple use by the same patient |
| Supplied Sterile | No (for all predicates) | No |
| Biocompatibility | Established for commonly used thermoformed plastic material. | Established for commonly used thermoformed plastic material (specifically, states "The material used in the FDA-Cleared ClearCorrect System (K113618) is exactly the same as the material used in the Dentti aligners (K151967)"). No additional testing required due to established biocompatibility. |
| Worn at Night | Yes (for all predicates) | Yes |
| Rx or OTC | Rx (for all predicates) | Rx |
How the Device Meets Acceptance Criteria (Study/Evidence):
The device meets the "acceptance criteria" by demonstrating substantial equivalence to the predicate devices through a detailed comparison of:
- Design: The Dentti System's design as a series of clear plastic aligners that move teeth gently in small increments is presented as technologically identical to predicate systems (page 4).
- Indications for Use: The stated indications for use are explicitly compared and found to be similar to the predicate devices (page 6).
- Material Composition: The Dentti System uses the same thermoformed polyurethane material (Zendura) as the ClearCorrect System (K113618) predicate. This pre-established biocompatibility and material usage eliminate the need for new testing (page 4).
- Mechanism of Action: The mechanism (mild force application for tooth movement) is described as following the same principles as conventional orthodontics and the predicate devices (page 6).
- Technological Characteristics: Other characteristics such as software usage, aligner design (covering surfaces like a custom tray, with an option for attachments), single use by the patient, non-sterility, and Rx-only classification are all shown to be equivalent to the predicates (page 6).
The submission explicitly states on page 5: "No bench testing was warranted for this product because the scientific literature and similarity in design, materials and use to the predicate devices assure that the aligners are suitable for the specified intended use." This indicates that direct performance testing for acceptance criteria was not performed for the Dentti System due to its demonstrated substantial equivalence to already approved devices.
Based on the provided document, the following information is not applicable or not provided:
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
No specific test set data is provided, as the submission relies on substantial equivalence rather than new performance testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable, as no new clinical or performance test set was used for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no new clinical or performance test set was used.
5. 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. This device is an orthodontic aligner, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
Not applicable. This device is an orthodontic aligner, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The ground truth for this submission is the established safety and effectiveness of the predicate devices, against which the Dentti System demonstrated substantial equivalence.
8. The sample size for the training set:
Not applicable. No training set was used as this is not an AI/ML device.
9. How the ground truth for the training set was established:
Not applicable. No training set was used.
§ 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.