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K Number
K013801
Device Name
ULTRASAFE DENTAL INJECTION SYSTEM
Manufacturer
SAFETY SYRINGES, INC.
Date Cleared
2001-12-13

(28 days)

Product Code
MEG
Regulation Number
880.5860
Type
Special
Panel
HO
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

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.

Device Description

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.

AI/ML Overview

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.

§ 880.5860 Piston syringe.

(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).