(98 days)
Empower Clear brackets are intended for orthodontic movement of teeth as diagnosed by an orthodontist. It is used temporarily and is removed upon completion of orthodontic treatment. Empower Clear brackets are intended to be single use only.
The Empower Clear line of products is single-use devices intended for use in conjunction with comprehensive orthodontics to control the movement of individual teeth. The Ceramic Bracket combines the aesthetics of a ceramic bracket with the versatility and ease of self ligation. These brackets are comprised of several geometries that vary from bracket to bracket, corresponding to the intended tooth. These geometries contribute to the fit of the tooth and also impart the axial control of the energy from the archwire.
This document is a 510(k) premarket notification for the Empower Clear orthodontic bracket. It focuses on demonstrating substantial equivalence to predicate devices rather than proving a device meets specific acceptance criteria through a study with detailed performance metrics. Therefore, it does not contain the kind of information requested in the prompt regarding acceptance criteria, reported device performance, sample sizes, expert ground truth establishment, adjudication methods, or MRMC/standalone studies.
The document primarily provides:
- Device Description: Empower Clear line of single-use devices intended for use in comprehensive orthodontics to control tooth movement.
- Intended Use: Orthodontic movement of teeth as diagnosed by an orthodontist, used temporarily, removed upon completion of treatment, single use only.
- Technological Characteristics: Made of Alumina Oxide [Al2O3], same material as predicate devices (Radiance and In-Ovation C). Clip material for Empower Clear is the same as In-Ovation C.
- Biocompatibility Testing: States that biocompatibility testing was conducted and indicated the bracket material (Aluminum Oxide [Al2O3]) is safe for use, free of harmful extractables, and caused no oral mucosa irritation or skin sensitization. This is the closest approximation to a "study" mentioned, but it lacks specific quantitative acceptance criteria or detailed results suitable for the table requested.
- Substantial Equivalence Analysis: Compares Empower Clear to predicate devices (Radiance and In-Ovation C) based on material, intended use, single use, and non-sterile packaging, concluding they are "Equivalent." This is the core of the 510(k) submission.
Due to the nature of this 510(k) document, I cannot fulfill your request for detailed acceptance criteria and study results as it would be inappropriate to invent or infer data not present in the provided text.
The document's purpose is to show equivalence to existing devices, not to present a de novo study with performance metrics against a defined set of acceptance criteria in the way a medical AI/software device might.
§ 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.