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The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly and a reusable Syringe Plunger assembly that is indicated for use with pre-filled, 1.8mL, anesthetic cartridges for injection of anesthetic solution for profound anesthesia of oral tissues.

The Needle Guard sheath manually slides forward over the needle in between injections and after injection(s) have been completed. The Needle Guard helps protect dental healthcare professionals from accidental needlesticks.

The intended patient population is unrestricted and includes children and adults of all ages.

The UltraSafe Dental™ Injection System is a sterile, single use Needle Guard assembly to help prevent needlestick and a reusable Syringe Plunger assembly that is used to administer local anesthetic solutions.

This document is a 510(k) summary for the UltraSafe Dental™ Injection System, which is a medical device submission to the FDA. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria in the format requested.

The document primarily provides:

• Company and device information.
• Device description (sterile, single-use Needle Guard assembly and a reusable Syringe Plunger assembly).
• Intended use (injecting anesthetic into oral tissues with a needlestick prevention mechanism).
• Intended patient population (unrestricted, all ages).
• Intended environment of use (dental offices, clinics, oral surgery).
• Indications for use (for use with 1.8mL anesthetic cartridges; Needle Guard slides manually to protect from needlesticks).
• FDA's determination of substantial equivalence to a predicate device.

Therefore, I cannot populate the requested table and details because the provided text does not contain the necessary information regarding acceptance criteria, study design, sample sizes, ground truth establishment, or expert involvement.

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