(122 days)
The Carriere SLX 3D Clear orthodontic ceramic bracket system is in the movement of teeth during orthodontic treatment.
The Carriere SLX 3D Clear is a ceramic passive self-ligating orthodontic bracket system that directly bonds to the teeth to provide a treatment solution for patients with malocclusions of primary, permanent, or mixed dentition. Each bracket is comprised of four individual components; a polycrystalline alumina door, a polycrystalline alumina base, and two 304 stainless steel springs. The two springs are laser welded together and borne by the springs are the force giving mechanism in the bracket system, providing tactile and audible feedback for the clinician when opening and closing the door. The springs also provide a mechanism to keep all four components assembled throughout treatment. Because the Carriere SLX 3D Clear is a passive self-ligating bracket system, wherein the door portion of the bracket opens and closes to alternatively expose and conceal the archwire slot, the door replaces the need for a conventional ligature and retains the archwire while providing minimal friction throughout the treatment process. The bracket system is intended to be used throughout orthodontic treatment with an accompanying archwire to move the teeth to the desired occlusion by the clinician. The Carriere SLX 3D Clear bracket has an integral hook design, which allows for the attachment of elastics and other alternate force giving mechanisms to assist the clinician in producing the desired tooth movement. The bonding surface of the bracket has a mechanical undercut design, allowing the bracket to retain the adhesive and bond to the facial surface of the tooth. The application and removal of the Carriere SLX 3D Clear orthodontic ceramic bracket is similar to that of other orthodontic ceramic brackets. It requires orthodontic adhesive for bonding and standard orthodontic tools and techniques for de-bonding.
This document describes a 510(k) premarket notification for the "Carriere SLX 3D Clear" orthodontic ceramic bracket. This is a medical device, not an AI/ML powered device, so many of the questions related to AI/ML device evaluations (e.g., sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set size, ground truth for training set) are not applicable.
Here's an analysis of the provided information, focusing on the acceptance criteria and supporting studies relevant to this type of device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria / Test | Acceptance Standard (Implied) | Reported Device Performance |
|---|---|---|
| Biocompatibility Testing | Compliance with ISO 10993-1. | "The biocompatibility testing conducted met the requirements of the tests." |
| - Cytotoxicity | Met ISO 10993-1 requirements. | Passed |
| - Sensitization | Met ISO 10993-1 requirements. | Passed |
| - Irritation | Met ISO 10993-1 requirements. | Passed |
| Bond Strength Testing (Shear Bond Strength) | Substantially equivalent to predicate device, |
§ 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.