Anutra Medical Syringe Receives FDA 501k Approval

Improving a centuries-old device:

Our recent partnership with Anutra Medical in conjunction with Gilero Biomedical has resulted in the FDA approval and market launch of the Anutra Syringe.

Per Anutra Press Release:

“Morrisville, NC – In January 2015, Anutra Medical received 510k approval from the FDA on a new disposable, feedback aspiration syringe. This syringe is the first known innovation on the traditional, metal, one-handed aspiration dental syringe. Overcoming many shortcomings of the traditional dental syringes, Anutra Medical has developed a light, ergonomic, bulk-delivery, disposable dental syringe.

Until now, an aspiration dental syringe is limited to holding only one cartridge at a time. A cartridge is a small vial that typically holds 1.8 mL of fluid. Most dental restorative procedures require the use of multiple cartridges. As a result, Anutra Medical engineered the Anutra Feedback Aspiration Syringe® to hold up to 5 mL of fluid, a major innovation. To further enhance a clinician’s experience, the Anutra Feedback Aspiration Syringe® is designed with audible and haptic feedback. With the traditional metal syringe, it can be difficult to know just how much anesthetic is being injected into a patient.

With Anutra’s new syringe, it is easy for a clinician to both hear and feel a click for each milliliter that is being injected. Additionally, the Anutra Feedback Aspiration Syringe® is equipped with double-sided volume labeling to allow a dentist to easily see how much anesthetic is being administered regardless of the angle.”
-Anutra Medical, January 8, 2015

 

Our product and brand teams collaborated with Anutra on the industrial design of their Anutra Syringe conceptualization, CAD development, engineering collaboration, and prototype fabrication.

 

Below is a look inside our process:

For more on Anutra Medical, visit anutramedical.com, or the FDA press release here.