(191 days)
FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.
The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.
The provided text describes the 510(k) summary for the FiteBac® CC OrthoSeal device. Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format for the device's performance characteristics. Instead, it categorizes performance testing, and the reported performance is described as being "acceptable" and not raising "any new issues of safety or effectiveness" in comparison to predicate devices. The primary performance characteristic mentioned is "Bond Strength Testing."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Bond Strength (Equivalent to predicate devices) | Results of all conducted testing including Bond Strength Testing was found acceptable and did not raise any new issues of safety or effectiveness. (Implied equivalence to predicate devices) |
| Biocompatibility (Meeting ISO standards) | Sensitization: Acceptable |
| Cytotoxicity: Acceptable | |
| Irritation: Acceptable (Complied with ISO 10993-1, ISO 10993-5, ISO 10993-10) | |
| Cure Time | 10 seconds |
| Wavelength |
§ 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.