(263 days)
AcceleDent® Aura is intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement.
The AcceleDent® Aura is an orthodontic accessory for the treatment of tooth malocclusion. AcceleDent® Aura should be used by patients for twenty minutes per day in conjunction with standard orthodontic treatment.
The provided text describes a 510(k) premarket notification for a modified medical device, the AcceleDent® Aura, which is an orthodontic accessory. The submission focuses on expanding the indications for use to include patients undergoing orthodontic treatment with aligners.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the traditional sense of a pass/fail threshold for a specific performance metric. Instead, it relies on demonstrating substantial equivalence to predicate devices, particularly regarding clinical outcomes with aligners. The key "performance" aspect is the demonstration of facilitation of tooth movement.
| Acceptance Criteria (Implied) | Reported Device Performance (AcceleDent® Aura with aligners) |
|---|---|
| Demonstrate substantial equivalence by facilitating minor anterior tooth movement during orthodontic treatment with aligners. | In a retrospective cohort study, AcceleDent® Aura demonstrated a statistically significantly faster rate of tooth movement (p=0.0129) and **shorter overall treatment time (p |
§ 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.