(36 days)
Fluoride-releasing, light-cured bracket bonding system in the oral cavity of dental patients.
EVOLVE is a fluoride-releasing, light-cured, color changing adhesive for bonding any type of orthodontic bracket to any enamel, porcelain, composite or metal surfaces when properly conditioned. It is a highly filled, smooth, tacky paste that helps prevent bracket flotation and delivers maximum bond strength on curing. Its contrasting blue color facilitates the ease of placement and clean-up once cured. The material is supplied in push syringes or syringe tips.
The provided text describes a 510(k) submission for a dental orthodontic adhesive called EVOLVE and does not contain information about acceptance criteria or a study proving that the device meets such criteria.
The document is a premarket notification for a Class II dental device, asserting its substantial equivalence to a predicate device ("Light Bond with Fluoride"). The submission focuses on comparing the technological characteristics and intended use of EVOLVE with the predicate device to demonstrate similar safety and effectiveness.
Therefore, I cannot provide the requested information. The text does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes or data provenance for test sets.
- The number or qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
- Results from a standalone algorithm performance study.
- The type of ground truth used (beyond general statements about biocompatibility and physical properties).
- Sample size for the training set.
- How ground truth for the training set was established.
The study presented is essentially a comparison of the new device (EVOLVE) with a previously cleared predicate device (Light Bond with Fluoride) based on:
* Intended Use: Both are "Dental Bracket Adhesive."
* Chemical Composition: Both are "Light cured, fluoride-releasing, glass filled, Dimethacrylate-based composite."
* Mechanical/Physical Properties: Both are "Highly viscous, smooth, tacky paste. High bond strength."
* Biocompatibility: EVOLVE was tested and found to be "non-toxic."
The conclusion drawn by the applicant is that EVOLVE is as safe and effective as the predicate device because the proposed changes do not affect safety and efficacy. This is the basis for the FDA's "substantial equivalence" determination, not a study against specific acceptance criteria for performance metrics as would be seen for diagnostic AI/ML devices.
§ 872.3750 Bracket adhesive resin and tooth conditioner.
(a)
Identification. A bracket adhesive resin and tooth conditioner is a device composed of an adhesive compound, such as polymethylmethacrylate, intended to cement an orthodontic bracket to a tooth surface.(b)
Classification. Class II.