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- To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter - To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system - To measure relative (intra-patient) levels of activity of 2 muscles during a functional act

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Indications for use; 2 channel, hand held, mobile EMG amplifier 1. To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter 2. To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system 3. To determine the degree of relaxation (intra-patient) of 2 muscles at rest 4. To measure relative (intra-patient) levels of activity of 2 muscles during a function act

The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.

The GRINDCARE MEASURE device is indicated to aid in the evaluation of nocturnal bruxism by measuring the temporalis muscle EMG activity during sleep.

GRINDCARE MEASURE is a portable electromyographic (EMG) monitoring device. The device consists of the recorder, a tri-polar electrode and a docking station. The electrode is placed on the forehead with three integrated electrodes in close connection to the temporalis muscle by means of a double-adhesive patch incorporating three conductive gelpads and connected to the recorder. The device records EMG activity and processes the signal to detect a particular activity (tooth grinding/clenching). It uses EMG to sense contraction of the temporalis muscle that is associated with bruxing events. The EMG events are logged and stored on the recorder. This data can be transferred to a healthcare professional's PC for assessment of the user's bruxism.

Indications for use: 8 channel EMG amplifier 1. To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric 2. To clinically monitor up to eight different muscles as an aid in the diagnosis and treatments evaluation by recording the electrical activity of muscles of the stomatognathic system 3. To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest 4. To measure relative (intra-patient) levels of activity of several muscles during a functional act Indications for Use: 2 channel JVA amplifier 1. To record and display sounds / vibrations from the temporomandibular joints 2. To aid the clinician in his analysis of a joint sound/vibration by allowing him/her to see the waveform in various standard plots (together with K981563) 3. To aid the clinician in comparing a patient's current stand plots to previous recordings before, during and after treatment 4. To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations, allowing intra-patient comparisons (only) by the clinician

The BioEMG III is a multi-channel electromyographic amplifier which includes; a) eight (8) identical high-gain differential input amplifiers, b) eight (8) identical opto-coupler isolation units and c) eight (8) ourput buffer amplifiers. The overall amplification of the BioEMG III is calibrated to 5000X. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3 dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The BioEMG III includes an isolated power converter that converts non-isolated +5 vdc into isolated + 5 and - 5 vdc. It may be connected to a personal computer through an analog to digital converter. Only three (3) functions are provided by the BioEMG III; I) amplification, 2) bandwidth limiting and 3) electrical isolation of the patient. Analogous to the BioEMG II, the BioEMG III also incorporates two (2) additional inputs for recording vibrations from the left and right temporomandibular joints. They consist of: a) two (2) identical high-gain amplifiers and b) two (2) output buffer amplifiers. For these inputs no isolation is required because there is no electrical connection to the patient. The amplification is calibrated to 5000X and the bandwidth filtering is set from 30 Hz to 1000 Hz (± 3dB). These channels are also powered from an external +5 vdc non-isolated source, which is converted to +5 and -5 vdc. The vibration signals may also be connected to a personal computer through an analog to digital converter. The two (2) functions performed by these "JVA" channels include: 1) amplification and 2) bandwidth limiting.

1. To treat temporomandibular joint (TMJ) disfunction and associated pain 2. To relieve symptoms associated with muscle spasm 3. To relax muscles and establish a physiologic occlusion 4. To take occlusal registrations 5. To take denture impressions 6. To increase local blood circulation 7. To maintain or increase mandibular range of motic

The DOLOTENS DENTAL TM2 is an ultra low frequency muscle stimulator, sending an electrical impulse to the muscles via the nerves in order to provide a minor level of muscle contraction. This gentle contraction of the muscles provides a pumping action for the blood increasing circulation in the muscles. Muscle spasm is relieved because fresh nutrients are brought into the muscles and waste products are pumped out.

The BiteStrip is generally indicated for use by orofacial pain professionals or dentists, to aid in the evaluation and management of nocturnal masticatory muscles activity disorders, which may be related to the patient's bruxism. temporomandibular disorder (TMD) or other oral function disorders during sleep. The BiteStrip is intended as an aid in the evaluation of excessive nocturnal jaw muscle activity The device is generally indicated for use by orofacial pain professionals or dentists, to evaluate nocturnal masticatory muscle activity level. which may be related to the patient's braxism. temporomandibular disorder (TMD) or other oral function disorders during sleep.

The BiteStrip is a disposable diagnostic device. The device is intended for use in monitoring masseter muscle contractions during sleep. It is generally indicated for use by physicians to aid in the evaluation of the presence and severity of bruxism, to determine the need for treatment, and for treatment follow-up. The BiteStrip is specifically indicated to obtain a quantitative measure of masseter muscle contractions during sleep, which correlates with bruxism severity derived from formal sleep lab studies. The BiteStrip is intended for adult users during an overnight sleep episode, i.e., 4-6 hours. The BiteStrip display gives an indication of muscle contraction severity as a single number, from 0 to 3 (Where 0 is very low count, and 3 is high count) depending on the total number of masseter muscle contraction episodes that the patient performs for the duration of the test. This number is referred to as the Bscore. While both Bscore and traditional bruxism score are very similar, and have good correlation, the terms differ because the bruxism score is measured using sleep lab EMG and additional physiological measures (not only EMG signals), while the Bscore is obtained by EMG analysis alone.

For Jaw Tracking functions of this device: - Tracks mandibular movement and position . - . For the diagnosis of functionaldisorderssuch as TMJ/MPD syndrome, muscle tension, bruxing, and instability of occlusion - Identification of mandibular rest position . - Identification of interocclusal distance and freeway space . - . Monitors the position of the jaw in three dimensions - Represents the spatial position of the mandibular incisal edge relative to the skull . For electromyographic function of this device: - Intended for use for muscles of mastication, especially temporalis, masseter, and digastric ● - . Designed to perform a limited number of functions in dental diagnosis - For use as a stand alone system for clinical monitoring of up to eight differentmuscles. it is ■ ideally suited for diagnosis and treatment evaluation by recording function of the muscles of the stomatognathic system - The determination of the degree of relaxation of a particular muscle or muscle group at rest . - The precise measurement of relative levels of contraction of several muscles during a ■ functional test For both functions of this device: - Diagnosis and management of TMJ/MPD disorders, orthodontic patients, denture patients, . and reconstruction patients. The addition of the feature described in this new Premarket Notification does not expand upon the above indicated uses.

The Model K6-I Diagnostic System is a surface electromyographic device that measures and records electrical potential emanating from muscle (in addition to its ability to track and document mandibular position/range of motion). The feature being added to the software of this device, Fast Fourier Transformation (FFT) of captured data, has the same technological characteristics as other legally marketed devices described above and in the Special 510(k).

Indications for Use: At the present time, comparisons between patients of electromyograms, sonograms and / or jaw traces should not be made, Sufficient normative data have not been collected to support such population-based measurements as "frean electromyographic clench," "standard deviation (Jaw Tracking) of freeway space," "integral (sonograph) of sound intensity" "average jaw tracing of chewing," etc., for non diseased individuals as well as for patients having various disease entitles that are now lumped within the terminology known as "TemporomandIbular Disorders and Associated Orofacial Pain (TMD/MPD)." Jaw Tracking - To track mandibular movement and position - To aid in the diagnosis of TMJ / MPD syndrome, muscle tension and bruxing [instability of occlusion] - To identify mandibular rest position and to identify interocclusal distance and freeway space - To monitor the position of the jaw in three dimensions - To represent the spatial position of the mandibular incisal edge relative to the skull - To provide Baseline measurements for future reference Electromyography - To record electrical activity of muscles of the stomatognathic system, especially temporalis, masseter and digastric - To clinically monitor up to eight different muscles as an aid in diagnosis and treatment evaluation by recording the electrical activity of the muscles of the stomatognathic system. - To determine the degree of relaxation (intra-patient) of a single muscle / group of muscles at rest - To measure relative (intra-patient) levels of activity of several muscles during a functional act - To provide Baseline measurements for future reference Sonography, joint vibration (sound) recording - To record and display sounds / vibrations from the temporomandibular joint - To aid the clinician in his analysis of a joint sound / vibration by allowing him to see the waveform in various standard plots - To aid the clinician in companing a parient's current standard plots to previous recordings before, during and after treatment - To provide numerical values that can be used to quantify the physical characteristics of the sounds / vibrations allowing intra-bationt commissions (only) by the clinician - To provide Baseline measurements for future reference

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