| No | Primary DI | Version or Model | Catalog Number | Device Description | Product Code | Product Code Name | Device Class | Brand Name |
|---|---|---|---|---|---|---|---|---|
| 1 | B915015700701 | 01570070 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | Plane Analyse DigiPro |
| 2 | B915011700700 | 01170070 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | Plane Analyse DigiPro |
| 3 | B915015700401 | 01570040 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | ARCUSdigma 3 |
| 4 | B915015700111 | 01570011 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic |
| 5 | B915015700101 | 01570010 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic |
| 6 | B915011700400 | 01170040 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | ARCUSdigma 3 |
| 7 | B915011700110 | 01170011 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic |
| 8 | B915011700100 | 01170010 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic |
| 9 | B915015700301 | 01570030 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | SICAT JMT blue |
| 10 | B915015700501 | 01570050 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | zebris for ceramill |
| 11 | B915015700211 | 01570021 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | Tizian JMA Optic |
| 12 | B915011700500 | 01170050 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | zebris for ceramill |
| 13 | B915011700210 | 01170021 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | Tizian JMA Optic |
| 14 | B915015700711 | 01570071 | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | PlaneAnalyser II | |
| 15 | B915015700201 | 01570020 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic Schütz |
| 16 | B915011700710 | 01170071 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | PlaneAnalyser II |
| 17 | B915011700200 | 01170020 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | NFS | Device, Jaw Tracking, For Monitoring Jaw Positions | 1 | JMA Optic Schütz |
| No | Primary DI | Version or Model | Catalog Number | Device Description | Brand Name | Organization Name |
|---|---|---|---|---|---|---|
| 1 | 03770022347229 | KIT | KIT | A set of trackers intended to be placed on the patient’s head and in patient’s m A set of trackers intended to be placed on the patient’s head and in patient’s mouth including :- Mandibular tracker - Frontal tracker- pen tracker | KIT PATIENT | MODJAW |
| 2 | 03770022347144 | TALLY | Pen Tracker | The pen is used in order to collect positioning of reference points in space.The The pen is used in order to collect positioning of reference points in space.The pen is used to calibrate the precision of the device. | Pen Tracker | MODJAW |
| 3 | 03770022347120 | TIARA | Frontal Tracker | Frontal Tracker | MODJAW | |
| 4 | 03770022347106 | TIARA2 | Rear band | Rear band | MODJAW | |
| 5 | 03770022347083 | SMILIT | Mandibular tracker | Mandibular tracker | MODJAW | |
| 6 | 03770022347069 | FORKS | Forks (x20) | Single-use support for the SMILIT mandibular tracker, which is fixed to the pati Single-use support for the SMILIT mandibular tracker, which is fixed to the patient's teeth. | Fork | MODJAW |
| 7 | 03770022347045 | NAVEX2 | Fiducials (x36) | Fiducials are the reflective targets fixed on the different trackers (pen, front Fiducials are the reflective targets fixed on the different trackers (pen, frontal, mandible) and should reflect infra-red light with required intensity. | NAVEX | MODJAW |
| 8 | 03770022347014 | TIMR | TIM Right-handed US | The medical device Tech in Motion® includes the following parts:• A camera to de The medical device Tech in Motion® includes the following parts:• A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion.• A set of trackers intended to be placed on the patient’s head and in patient’s mouth.• A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in right-handed configurations. | Tech In Motion | MODJAW |
| 9 | 03770022347007 | TIML | TIM Left-handed US | The medical device Tech in Motion® includes the following parts:• A camera to de The medical device Tech in Motion® includes the following parts:• A camera to detect trackers positions through infra-red emission. • A specific software solution installed on a touchscreen PC that allows the visualisation of 3D dental models in motion.• A set of trackers intended to be placed on the patient’s head and in patient’s mouth.• A pen tracker used by the dentist to acquire trackers positions (infrared communication to the camera then transferred to a dedicated software). • An operational cart designed to hold and position the camera and the touchscreen panel PC. The camera is mounted on the cart in left-handed configurations. | Tech In Motion | MODJAW |
| 10 | EKAV100523010 | 1.005.2301 | NA | This is a medical device. | ARCUS digma USB | KAVO DENTAL GMBH |
| 11 | D79209960 | K7 CMS Sensor Array | 0996 | Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. | K7 CMS Sensor Array | MYOTRONICS NOROMED, INC |
| 12 | D79209940 | K7/CMS | Multiple sensors in an extremely light weight (four ounce) spectacle-like array, Multiple sensors in an extremely light weight (four ounce) spectacle-like array, track the motion of a tiny magnet attached to the lower incisal gingiva with adhesive material. The configuration is totally non-invasive and, unlike clutches, does not interfere with patient function. The opposing sensors are wide apart permitting unobstructed access to the oral cavity for taking bite registrations and other clinical procedures, and the system is virtually immune from effects of slight head motion or nearby metallic or electronic interference. A patient education mode is included to simplify patient understanding and staff training. | K7 Evaluation System-CMS | MYOTRONICS NOROMED, INC | |
| 13 | D79209930 | K7/EMG | Utilizing high quality bipolar surface electrodes, surface EMG data can be taken Utilizing high quality bipolar surface electrodes, surface EMG data can be taken from up to eight muscle sites simultaneously and in real time. The program permits taking electromyography data either at rest or in function. All eight channels may be displayed simultaneously, for a period of 15 seconds (one visual screen width). The K7/EMG signal processing circuitry provides unsurpassed protection against system noise or motion artifact. The patient education mode permits quick and easy patient education as to status of masticatory muscles. | K7 Evaluation System-EMG | MYOTRONICS NOROMED, INC | |
| 14 | D79209750 | K7/ESG | TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sens TMJ Vibration (Sound) Evaluation System. A lightweight headset holds highly sensitive vibration transducers over each TM joint, enabling simultaneous, bilateral capture of tissue vibrations emanating from joint sounds. Vibration (sound) data is correlated to vertical dimension of opening and closing, providing clinicians with valuable information to aid in assessing the status of articular disk and joint function. | K7 Evaluation System-ESG | MYOTRONICS NOROMED, INC | |
| 15 | B915015700711 | 01570071 | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | PlaneAnalyser II | ZEBRIS MEDICAL GMBH | |
| 16 | B915015700701 | 01570070 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | Plane Analyse DigiPro | ZEBRIS MEDICAL GMBH |
| 17 | B915015700501 | 01570050 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | zebris for ceramill | ZEBRIS MEDICAL GMBH |
| 18 | B915015700401 | 01570040 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | ARCUSdigma 3 | ZEBRIS MEDICAL GMBH |
| 19 | B915015700301 | 01570030 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | SICAT JMT blue | ZEBRIS MEDICAL GMBH |
| 20 | B915015700211 | 01570021 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | Tizian JMA Optic | ZEBRIS MEDICAL GMBH |
| 21 | B915015700201 | 01570020 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | JMA Optic Schütz | ZEBRIS MEDICAL GMBH |
| 22 | B915015700111 | 01570011 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | JMA Optic | ZEBRIS MEDICAL GMBH |
| 23 | B915015700101 | 01570010 | NA | Opto-Electronik System including Face-Bow for monitoring and tracking of lower j Opto-Electronik System including Face-Bow for monitoring and tracking of lower jaw movements and accessories | JMA Optic | ZEBRIS MEDICAL GMBH |
| 24 | B915011700710 | 01170071 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | PlaneAnalyser II | ZEBRIS MEDICAL GMBH |
| 25 | B915011700700 | 01170070 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | Plane Analyse DigiPro | ZEBRIS MEDICAL GMBH |
| 26 | B915011700500 | 01170050 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | zebris for ceramill | ZEBRIS MEDICAL GMBH |
| 27 | B915011700400 | 01170040 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | ARCUSdigma 3 | ZEBRIS MEDICAL GMBH |
| 28 | B915011700300 | 01170030 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements. | SICAT JMA blue | ZEBRIS MEDICAL GMBH |
| 29 | B915011700210 | 01170021 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | Tizian JMA Optic | ZEBRIS MEDICAL GMBH |
| 30 | B915011700200 | 01170020 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | JMA Optic Schütz | ZEBRIS MEDICAL GMBH |
| 31 | B915011700110 | 01170011 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | JMA Optic | ZEBRIS MEDICAL GMBH |
| 32 | B915011700100 | 01170010 | NA | Opto-Electronik Face-Bow for monitoring and tracking of lower jaw movements | JMA Optic | ZEBRIS MEDICAL GMBH |
| 33 | M482S4R0 | S-4R | SMALL TOOTH SHELL | Nobilium | CMP INDUSTRIES LLC | |
| 34 | M482M4R0 | M-4R | MEDIUM TOOTH SHELL | Nobilium | CMP INDUSTRIES LLC | |
| 35 | M482L4R0 | L-4R | LARGE TOOTH SHELL | Nobilium | CMP INDUSTRIES LLC | |
| 36 | M482EDENTB9000 | EDENTB900 | EDENT LOW TEMP TRAY 4L | Nobilium | CMP INDUSTRIES LLC | |
| 37 | M482DENTLTSUR0 | DENTLTSUR | DENTATE LOW TEMP SU | Nobilium | CMP INDUSTRIES LLC | |
| 38 | M482DENTLTSLR0 | DENTLTSLR | DENTATE LOW TEMP SL | Nobilium | CMP INDUSTRIES LLC | |
| 39 | M482DENTLTMUR0 | DENTLTMUR | DENTATE LOW TEMP MU | Nobilium | CMP INDUSTRIES LLC | |
| 40 | M482DENTLTMLR0 | DENTLTMLR | DENTATE LOW TEMP ML | Nobilium | CMP INDUSTRIES LLC | |
| 41 | M482DENTLTLUR0 | DENTLTLUR | DENTATE LOW TEMP LU | Nobilium | CMP INDUSTRIES LLC | |
| 42 | M482DENTLTLLR0 | DENTLTLLR | DENTATE LOW TEMP LL | Nobilium | CMP INDUSTRIES LLC | |
| 43 | M482DENTATEB7000 | DENTATEB700 | DENTATE LOW TEMP TRAY MU | Nobilium | CMP INDUSTRIES LLC | |
| 44 | M482DENLTSU120 | DENLTSU-12 | DENPLANT L-TEMP SM-UP CSE | Nobilium | CMP INDUSTRIES LLC | |
| 45 | M482DENLTSL120 | DENLTSL-12 | DENPLANT L-TEMP SM-LO CSE | Nobilium | CMP INDUSTRIES LLC | |
| 46 | M482DENLTMUS0 | DENLTMUS | DENPLANT LT MU SAMPLE | Nobilium | CMP INDUSTRIES LLC | |
| 47 | M482DENLTMU120 | DENLTMU-12 | DENPLANT L-TEMP MD-UP CSE | Nobilium | CMP INDUSTRIES LLC | |
| 48 | M482DENLTMLS0 | DENLTMLS | DENPLANT LT ML SAMPLE | Nobilium | CMP INDUSTRIES LLC | |
| 49 | M482DENLTML120 | DENLTML-12 | DENPLANT L-TEMP MD-LO CSE | Nobilium | CMP INDUSTRIES LLC | |
| 50 | M482DENLTLU120 | DENLTLU-12 | DENPLANT L-TEMP LG-UP CSE | Nobilium | CMP INDUSTRIES LLC |