ESSENTIAL DENTAL SYSTEMS, INC. 5031-00 SafeSiders

The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.

Cutaneous Electrode Garment

Positioning caps for implant pick-up

Tinted Pearlescent Powder

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.

3M™ ESPE™ Adult Anterior Polycarbonate Replacement Crown, Upper Right Cuspids, Size 31, 31

Convenience kit no Lidocaine

The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.

Cutaneous Electrode Garment

Positioning caps for implant pick-up