(77 days)
Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity.
Miltex® Dental Aspirating Syringes include Standard Aspirating Syringes, Petite Aspirating Syringes, Self-Aspirating Syringe, Lightweight Self-Aspirating Syringe, Articulating Barrel Syringe and GripRite™ Standard and Petite Aspirating Syringes. All syringes are made of chrome-plated brass and stainless steel; Lightweight Self-Aspirating Syringe has aluminum handle. Syringes are reusable, sterilizable and packaged non-sterile.
This document is a 510(k) summary for the Miltex® Dental Aspirating Syringes, which is a traditional medical device (not an AI/ML powered device). Therefore, the requested information regarding acceptance criteria, study details, and AI/ML specific performance metrics (like MRMC studies or standalone algorithm performance) is not applicable or available in this submission.
The 510(k) summary establishes substantial equivalence to predicate devices based on:
- Intended Use: "Miltex® Dental Aspirating Syringes are indicated to be used in conjunction with anesthetic needles and anesthetic cartridges for injection of anesthetic solutions in the oral cavity." This is the same as the predicate devices.
- Fundamental Technology, Design, and Materials: The document states the Miltex® syringes are substantially equivalent to the legally marketed predicate devices in these aspects. The devices consist of chrome-plated brass and stainless steel (and aluminum for one specific model), are reusable and sterilizable, and are packaged non-sterile, consistent with standard dental aspirating syringes.
The FDA's review confirms substantial equivalence, allowing the device to be marketed, subject to general controls and applicable additional controls for Class II devices.
§ 872.6770 Cartridge syringe.
(a)
Identification. A cartridge syringe is a device intended to inject anesthetic agents subcutaneously or intramuscularly. The device consists of a metal syringe body into which a disposable, previously filled, glass carpule (a cylindrical cartridge) containing anesthetic is placed. After attaching a needle to the syringe body and activating the carpule by partially inserting the plunger on the syringe, the device is used to administer an injection to the patient.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.