Comfort Control Syringe System

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K002387 ↗

FDA Product Code

EJI

Device Class

Class II

Regulation

21 CFR Part 872.6770

Advisory Committee

Dental

FDA Decision

SESE Substantially Equivalent

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• What is the Comfort Control Syringe System used for?

  The Comfort Control Syringe System is a cartridge syringe intended to inject anesthetic agents subcutaneously or intramuscularly, specifically designed for dental procedures.

• How is the Comfort Control Syringe System supplied?

  The system consists of a metal syringe body into which a disposable, previously filled, glass carpule containing anesthetic is placed. It is supplied as a Class II device under product code EJI.

• Is the Comfort Control Syringe System single-use or reusable?

  The device is not specified as single-use or reusable in the provided information. The syringe body appears to be metal, while the carpule containing the anesthetic is disposable.

• What regulatory approvals does the Comfort Control Syringe System have?

  The Comfort Control Syringe System has FDA 510(k) clearance K002387, issued on September 28, 2000, and is classified as a Class II device under product code EJI for dental use.