Search Results

Oral Bond is indicated to be used as an adjunct to temporally assist in securing periodontal dressings.

Oral Bond is a sterile, liquid dental cement containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2 or D&C Yellow #10) . Oral Bond is supplied in a multiuse vial. The liquid is syrup-like in viscosity and polymerizes within seconds after contact with water.

The provided text is a 510(k) premarket notification for a medical device called "Oral Bond," a dental cement. It focuses on demonstrating substantial equivalence to a predicate device ("PeriAcryl"). The document does not contain information about device performance meeting a set of acceptance criteria in the context of a clinical study or rigorous performance evaluation with a test set, expert ground truth, or MRMC studies.

Therefore, I cannot fulfill the request to describe acceptance criteria and a study proving the device meets them based on the provided text. The document's purpose is to show an administrative equivalence to a legally marketed device, not to present a detailed performance evaluation from a new study meeting the criteria you outlined.

The sections for which no information can be extracted from the text are:

• A table of acceptance criteria and the reported device performance
• Sample sized used for the test set and the data provenance
• Number of experts used to establish the ground truth for the test set and their qualifications
• Adjudication method for the test set
• If a multi reader multi case (MRMC) comparative effectiveness study was done, and its effect size
• If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
• The type of ground truth used
• The sample size for the training set
• How the ground truth for the training set was established

Ask a specific question about this device