Search Results

Use for almost all bonding needs in restorative dentistry. Chemical cure luting and chemical cure composites, namely PermaFlo DC, also bonds to light cured PQ1. PQ1 is conducive for bonding to:

1. Dentin and Enamel using composite or amalgam
2. Porcelain
3. Metal
4. Composite repair

PQ1® Single Syringe Bonding Agent

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent (PQ1 Single Syringe Bonding Agent). This document does not describe a study with acceptance criteria and reported device performance in the way a clinical trial or AI/ML device study would.

The information requested in the prompt (acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC, standalone performance, training set details) is typically found in the summary of safety and effectiveness data for devices that either have specific performance metrics (like AI/ML devices, diagnostic tests) or require a clinical trial to demonstrate safety and effectiveness.

For a device like a dental bonding agent, the "acceptance criteria" for FDA clearance primarily revolve around demonstrating "substantial equivalence" to a legally marketed predicate device. This typically involves:

• Same intended use: The new device is intended for the same use as the predicate device.
• Same technological characteristics: The new device has the same technological characteristics as the predicate, or if it has different technical characteristics, those characteristics do not raise new questions of safety and effectiveness. If different, performance data (bench testing, some clinical data, etc.) is provided to demonstrate that the device is as safe and effective as the predicate.

In this specific document, the FDA states that they have "reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent...to legally marketed predicate devices."

Therefore, I cannot extract the requested information from the provided text about acceptance criteria met by a specific study with performance metrics. The document confirms substantial equivalence based on the submitted 510(k) notification, which would have contained data (likely bench testing for bond strength, durability, etc.) to support this claim, but those specific details are not present in this letter.

Ask a specific question about this device

Ask a specific question about this device

Use for almost all bonding needs in restorative dentistry. Ease of use and unsurpassed bond strength in a single syringe primer/ocnding resin makes PQ1 the agent of choice for most light cure bonding needs. Also use PQ1 with chemical sure luting and chemical cure composite (e.g. Permalute). PQ1 is conducive for bonding to:

• 1. Dentin and Enamel i sing composite or amalgam
• 2. Porcelain
• 3. Metal
• 4. Composite repair

Modification of PQ1

The provided text is a 510(k) clearance letter from the FDA for a dental bonding agent named "PQ1" (or "PO1" in one instance), with a submission number K983668. This document outlines the FDA's decision regarding the substantial equivalence of the device but does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for the specific details about the acceptance criteria and the study that proves the device meets them based solely on the provided text.

The document indicates:

• Device Name: PQ1 (also listed as PO1)
• 510(k) Number: K983668
• Indications for Use: For almost all bonding needs in restorative dentistry, including bonding to dentin, enamel, porcelain, metal, and for composite repair. It is also used with chemical cure luting and chemical cure composite.

To answer your questions, I would need access to the actual 510(k) submission document (K983668) from Ultradent Products, Incorporated, which would contain the performance data and details of any studies conducted.

Ask a specific question about this device