(552 days)
The Custom-made Invisible Aligners is indicated for the treatment of tooth malocclusion in patients with permanent dentition (i.e., all second molars). The Custom-made Invisible Aligner positions teeth by way of continuous gentle force.
The Custom-made Invisible Aligners System is a series of dental aligners that are fabricated of clear, thin thermoformed Polyethylene terephthalate (PETG) plastic to progressively reposition the teeth. Corrective force to reposition the teeth is delivered via minor changes into a position in each subsequent aligner.
The provided text describes a 510(k) premarket notification for a medical device, the "Custom-made Invisible Aligners." This type of submission aims to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. For this submission, the manufacturer primarily relies on non-clinical performance testing and biocompatibility testing, rather than clinical studies or AI algorithm performance studies. Therefore, many of the requested items related to AI and human reader studies are not applicable.
Here's an analysis based on the provided document:
Acceptance Criteria and Reported Device Performance
1. Table of acceptance criteria and the reported device performance:
| Test Item | Test Standard/Method | Acceptance Criteria | Result |
|---|---|---|---|
| Thickness | Internal standard | ≤1.2mm | Pass |
| Appearance | "ZMT-FD-SS-052" | No crack or bubbling; No defects | Pass |
| Odor | Internal standard | Odorless | Pass |
| Density | ASTM D792-2013 | ≤2.6g/cm³ | Pass |
| Water absorption | ISO20795.1-2013 | ≤32 μg/mm³ | Pass |
| Dissolution | ISO20795.1-2013 | ≤1.6 μg/mm³ | Pass |
| Color stability | ISO20795.1-2013 | No change | Pass |
| Tear resistance | ISO6383.1-2015 | >200N/cm | Pass |
| Wear resistance | ISO9352-2012 |
§ 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.