# K013801: Ultrasafe Dental Injection System

- Pathway: 510(k) (Special)
- Applicant: Safety Syringes, Inc.
- Decided: Dec 13, 2001 after 28 days
- Product code: MEG (Syringe, Antistick)
- Device class: 2
- Regulation: 21 CFR 880.5860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) UltraSafe Aspirating Syringe: named in the summary without a submission number

## Recalls of this device
- Sep 5, 2002 · Not classified · Z-0444-03: Package integrity not validated. Sterility not assured.

## Indications for 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.

Source page: https://510kreport.com/device/K013801
Methodology: https://510kreport.com/methodology