ORTHO TECHNOLOGY, INC. HS-KIT Galaxy™

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.

KIT, ORTHOPEDIC. Includes: 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052), 133 - REST, CERVICAL HEAD (00810050240055), 145 - WEDGE, 7” x 7” x 21.25” (00810050240062), 169 - RECTANGLE, 3” x 7.5” x 10” (00810050240413)

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Centrals, Size 14, 14

7.1mm Round Fast Cutting Bur

6.3mm Round Fast Cutting Bur

2.4mm Round Bur

4.0mm Diamond Round Bur

5.0mm Egg Bur

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.

KIT, ORTHOPEDIC. Includes: 102 - HOLDER, ADULT AP-PA HEAD (00810050241205), 121 - BLOCK, OBLIQUE FINGER, 3.13” x 5.5” x 5” (00810050241052), 133 - REST, CERVICAL HEAD (00810050240055), 145 - WEDGE, 7” x 7” x 21.25” (00810050240062), 169 - RECTANGLE, 3” x 7.5” x 10” (00810050240413)

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Centrals, Size 14, 14