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Cartridge Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.

Dental Aspirating Syringes/Self Aspirating Syringes include standard, petite and medium sizes. All syringes are made of stainless steel and have aluminum handles. Syringes are reusable, sterilizable and packaged non-sterile.

This document is a 510(k) Premarket Submission for a Cartridge Dental Syringe (K092943). It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, the provided text does not contain the information requested regarding acceptance criteria and a study that proves the device meets those criteria, as it's a premarket notification document for a medical device seeking market clearance, not a study report.

The document indicates that the device is a simple cartridge syringe for dental anesthetic injections and is being found "substantially equivalent" to existing devices on the market. This type of submission relies on demonstrating that the new device has similar technological characteristics and intended use as a legally marketed predicate device, rather than requiring new clinical performance data against specific, quantitative acceptance criteria.

Therefore, it is not possible to fill out the requested table and information points from the provided text.

Explanation of what this document is (and isn't):

• 510(k) Premarket Submission: This is a regulatory pathway in the US for medical devices that are substantially equivalent to a legally marketed predicate device. It demonstrates that the new device is as safe and effective as the predicate.
• Substantial Equivalence: This means the device has the same intended use and the same technological characteristics as the predicate, or it has different technological characteristics but does not raise different questions of safety and effectiveness, and the information submitted demonstrates that the device is as safe and effective as the predicate device.
• Absence of Acceptance Criteria and Performance Study: For many Class I and Class II devices seeking 510(k) clearance, extensive clinical studies with quantifiable acceptance criteria are not required if substantial equivalence can be established through technological comparison, design features, and material properties. The FDA letter confirms the device classification (Class II) and that it's subject to general controls, indicating that a full PMA (Premarket Approval) with extensive clinical trial data was not necessary.

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