Search Results

Aromacryl's relining, repairing/rebasing resin is indicated for the fabrication of flavored/fragranced orthodontic appliances.

The Aromacryl device is an orthodontic appliance using industry standard stainless steel wire and Aromacryl polymer and monomer. Aromacryl can be used to fabricate devices, such as orthopedic and functional appliances to correct malocclusions or post-treatment retention devices known as hawley retainers. The Aromacryl product offers the patient a pleasant tasting appliance by the addition of FDA approved food grade flavoring that is GRAS (Generally Recognized As Safe) for this application.

I am sorry, but based on the provided text, there is no information about acceptance criteria, device performance, study details (sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance), or ground truth establishment for a device.

The provided document is a 510(k) summary and an FDA clearance letter for an "Aromacryl flavored/fragranced Orthodontic Appliance." It primarily describes:

• Device Name: Aromacryl flavored/fragranced Orthodontic Appliance
• Classification: Resin, denture, relining, rebasing (Regulation Number: 872.3760, Class II)
• Purpose: To make orthodontic appliances (like Hawley retainers) with pleasant tasting/fragranced polymer and monomer, offering an alternative to plastic-tasting appliances.
• Substantial Equivalence: The FDA determined it is substantially equivalent to legally marketed predicate devices.
• Indications for Use: Aromacryl's relining, repairing/rebasing resin is indicated for the fabrication of flavored/fragranced orthodontic appliances.

While it's a medical device, the provided text does not contain any technical details about performance metrics, clinical studies, or acceptance criteria that would typically be required to answer your specific questions. The 510(k) process focuses on demonstrating substantial equivalence to a predicate device, and often, extensive performance studies as you've outlined are not included in the publicly available summary unless specifically requested or if the device introduces novel technology.

Ask a specific question about this device