ESSENTIAL DENTAL SYSTEMS, INC. 2535-0 EZ-Fit

First Aid Kit Wihout Drug (Content : Adhesive bandages in a variety of different sizes and shapes + Non-adherent sterile Gauze Pad + Cleansing wipe (with alcohol)) This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.

The Test of Variables of Attention (T.O.V.A.) kit contains the hardware and software necessary to install and administer the T.O.V.A. continuous performance test. The T.O.V.A. provides healthcare professionals with objective measurements of attention and inhibitory control. The visual T.O.V.A. aids in the assessment of, and evaluation of treatment for, attention deficits, including attention-deficit/hyperactivity disorder (ADHD). The auditory T.O.V.A. aids in the assessment of attention deficits, including ADHD. T.O.V.A. results should only be interpreted by qualified professionals.

Burr, Oval, 10 flute, 3.0mm

Device is a stool collection kit for at-home use.

The Cartilage Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live cartilage biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of MACI - (Container, specimen mailer and storage, temperature controlled, sterile)

The Skin Biopsy Transport Kit, developed by Vericel Corporation, provides a way for surgeons to preserve a live skin biopsy and return it to the Vericel Cambridge Manufacturing Facility for the production of EPICEL - (Container, specimen mailer and storage, temperature controlled, sterile)