(64 days)
The Pontic Paint is intended for use as a light cure coloring agent of thermoplastic aligners.
The Pontic Paint is a light cure coloring agent for thermoplastic aligners. The Pontic Paint is formulated in a viscosity that is easily mixed and bonds chemically to a typically difficult to adhere to surface, a thermoplastic aligner now common in the dental industry. This paint, upon polymerization, is in Vita Shades A1. A2, and Bl allowing the appearance of a realistic tooth under the thermoplastic aligner thereby making a missing tooth situation appear aesthetically pleasing to the patient undergoing orthodontic treatment using clear aligner systems. The light cure property of the paint allows the user to determine the polymerization time required by simply exposing the adhesive to an LED light source until set. The Pontic Paint will be marketed in a jar for ease of mixing and application with a brush.
The provided text describes a 510(k) summary for a medical device called "Pontic Paint." However, the document does not contain any information about acceptance criteria, device performance results, or a study to prove the device meets acceptance criteria.
The document primarily focuses on:
- Identifying the applicant (Reliance Orthodontic Products, Inc.)
- Describing the device ("Pontic Paint" - a light-cure coloring agent for thermoplastic aligners)
- Stating its intended use and population
- Identifying the predicate devices (Flowtain™ and Plastic Conditioner)
- The FDA's decision of substantial equivalence.
Therefore, I cannot provide the requested information in the tables or bullet points because it is not present in the provided text.
§ 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.