Precision Dental Products LLC OBEV0001 OneBite Evolution

The BI IMAGE-X EVOLUTION® device is an extraoral x-ray generator that provides the radiation necessary for the formation of a radiographic image from which a radiographic diagnosis may be made.The BI IMAGE-X EVOLUTION® is an extraoral x-ray generator system designed to be used in combination with an intraoral image receptor for radiographic examinations (which assist in diagnosis of diseases of the teeth, jaw, and oral structure) by dental professionals.

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.