Search Results

MT-Bone is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits: · Periodontology: Periodontal therapy and debridement for all types of periodontal diseases. including periodontal pocket irrigation and cleaning; · Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation; · Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

MT-Bone is a piezoelectric ultrasonic device designed for oral bone surgery. MT-Bone uses piezoelectric ultrasound technology to generate mechanical micro vibrations that can cut, drill or abrade through mineralized structures using appropriate inserts. This allows an efficient and safe action which preserves the integrity of the osteotomized surfaces. The micrometric, ultrasonic vibrations of the inserts provide greater precision and a selective action compared to traditional methods such as drills or oscillating saws (which act with macro vibrations), therefore minimizing traumatic effect on soft tissues. Depending by the Indication for use a lot of different type of inserts are available in Mectron portfolio.

The Surgical Drive System (Model: ES70, ES90, E8) is indicated for: drilling, milling, sawing, screwing (for positioning) of osteosynthesis screws, implants and plate systems in soft and hard tissue. Including: ENT surgery and Maxillofacial surgery

The Surgical Drive System is an electrical drive unit, including a motor, power console, foot control, connection cables, and other accessories. It is intended for use in surgical procedures involving incision/cutting, removal, drilling, and sawing of soft and hard tissue and bone. The basic function of the Surgical Drive System is the conversion of electrical energy into a mechanical rotary motion. The control unit is used to control the connected motor and the integrated pump. The integrated touch display is used to monitor the actual settings and to change, within predetermined limits, the operating parameters. The foot control is used for activation of the motor and changing parameters e.g. program, pump state, and motor direction. The motor's function is to provide power for handpieces with the gear ratio (1:1, 1:4.2, 1:5, 3.2:1, 3.4:1, 40:1), the Max. speed of the motor is 40000 min-1, and it is designed with an ISO 3964 Type 3 connector.

The Guided Surgery Kit is designed to hold various dental surgical drills and instruments to organize, steam sterilize, and transport between uses. The guided surgical drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement. The kit is to be enclosed in a FDA cleared steam sterilizable wrap (maximum thickness KC300) and sterilized in a FDA cleared sterilizer for one of the following cycles: (1) Prevacuum Steam – At 132°C for 4 minutes with a 20 minute dry time. (2) Gravity Steam At 132°C for 15 minutes with a 30 minute dry time. · The kit is intended for sterilization of non-porous loads. · Do not stack kits during sterilization. · Implant Direct Sybron Manufacturing LLC does not make any lumen claims for the Sterilizable Guided kit.

The Guided Surgery Kit is offered in 2 complete kit variations for 3 implant systems: Legacy, Simply lconic, and InterActive as a reusable perforated tray for purposes of transport, steam sterilization and storage of dental instruments, similar to the reference device Standard Sterilizable Tray (K202524). The kit is sold non-sterile and contains site preparation instruments, dental driving tools, prosthetic driving tools and ratchet tool which can be used for implant placement. The proposed Guided Surgical Drills are reusable surgical instruments designed to prepare an osteotomy for a dental implant procedure. The features remain unchanged from the predicate Surgical Drills (K200265) except for the addition of a Guide Body and Shoulder Stop. The addition of a Guide Body allows the proposed drills to function with guide sleeves which can be integrated into an existing surgical quide template to assist in the drilling sequence and placement of dental implants.

TRAUS SUS20, Piezo Surgery Engine Set, is intended for use in dental surgery including: osteotomy, osteoplasty, periodontal surgery and implantation.

TRAUS SUS20 has the function of piezo surgery by using ultrasonic mechanical vibration. TRAUS SUS20 consists of a control box (main unit), a piezo handpiece and a foot controller.

The Surgical Drills are intended to cut into maxilla or mandible to create an osteotomy for endosseous dental implant placement.

The proposed Surgical Drills are reusable invasive surgical instruments designed to prepare an osteotomy for a dental implant procedure. The base material of the drill is made of surgical grade stainless steel. The bone cutting portion of the drill may be coated with diamond like coating (DLC) or laser marked to indicate the depth marks. The Surgical Drills consist of straight drills, and cortical drills. Straight drills are available in diameters 3.2 to 5.1 mm. Step drills are available in diameters 2.3/2.0 to 5.4/4.8 mm. Cortical drills are available in diameters 3.2 to 7.0 mm. The straight and step drills have osteotomy depth indicators and are intended to make osteotomies for Implant Direct endosseous dental implants.

The Contour P-Insert System (CPIS) is an accessory attachment to the Dmetec Surgystar piezosurgery system. It is used by dental professionals during treatment of periodontal disease and oral surgery for the following intended uses: 1. Surgical procedures including osteotomy, osteoplasty, periodontal surgery and implantation. 2. Soft tissue debridement and removal, particularly in intrabony lesions.

The Contour P-Insert System (CPIS) is an accessory to the Dmetec Surgystar Piezosurgery System (DSPS). The CPIS comprises two sets of components. CPIS tips and CPIS shafts, as follows: - CPIS Shafts: The two CPIS shaft models (45 and 90) are machined from 431 stainless steel. Both models ● have an identical female threaded proximal end that is designed and configured to attach to the DSPS handpiece distal male threaded end. On the shafts' distal end, both models have an identical male threaded section that is designed and configured to attach the various models of CPIS tips. These models 45 and 90 differ primarily in that the CPIS 45 has a mid-shaft bend of 20.59 while the CPIS 90 does not. - CPIS Tips: The three CPIS tip models (Tri, WC and QT) are machined from PEEK ● (polyetheretherketone). All three tip models have an identical female unthreaded hole on the proximal end that is designed and configured to attach to the distal male threaded end of the CPIS shafts. These tips have different grooves, edges and vertices that abrade, ablate, cut and recontour oral tissues as intended by the operator. - CPIS Inserts: The CPIS inserts are created by the end user by attaching one CPIS tip to one CPIS shaft. By combining each of the three tip models with each of the two shafts models, six versions of CPIS insert can thus be created, depending on the clinical needs and professional judgement of the end-user. These resultant CPIS inserts are designated as follows: CPIS 45/WC, CPIS 45/QT, CPIS 90/Tri, CPIS 90/WC and CPIS 90/QT. The CPIS inserts are attached to the DSPS using the DSPS torque wrench. During use by the end user, the DSPS is powered, generating high frequency mechanical micro-vibrations in the handpiece, that is transmitted to the CPIS insert. The tip sides and tip end of the CPIS inserts are brought into contact with the patient's various oral tissue types to accomplish dental procedures where ablation, abrasion, cutting and/or recontouring of the target tissue is desired.

The PIEZOTOME CUBE is an ultrasonic surgical system that supply utilities to and serve as a base for dental tips. The PIEZOTOME CUBE consist of a control unit and handpiece intended for use in intraoral surgery procedures, including osteotomy, osteoplasty, periodontics and implantology.

SATELEC CUBE is an piezoelectric device that uses micro-vibrations of associated Tips, to perform the dental procedures defined in Indication for Use. PIEZOTOME CUBE consists of a Console, a Multifunction footswitch and a reusable Handpiece. The Console is the heart of the SATELEC PIEZOTOME CUBE. The Console contains the display board and the motherboard. Ultrasonic Handpiece and Footswitch are connected to the Console. The Touch screen present on the front panel is used to define the settings of the SATELEC PIEZOTOME CUBE (Ultrasonic modes, irrigation flow values). The Ultrasonic Handpiece is held in the Practitioner's hand. The Ultrasonic Handpiece is connected to the Console via a Handpiece Cord. The Handpiece is dedicated to Dental Bone Surgery procedures. The Ultrasonic Handpiece is equipped with a Piezoelectric Transducer. The Piezoelectric transducer converts the Electrical Signal delivered by the Console into mechanical micro-vibrations. The Ultrasonic Handpiece is reusable and Sterilizable by autoclaving. Tips are fixed by means of a Wrench at the extremity of the Ultrasonic Handpiece. Tip are in direct contact to the patient. The ultrasonic mechanical vibrations are transmitted to the Tip. The Pump housing is designed to accommodate SATELEC Irrigation Tubing cassettes. Irrigation Tubings are Single Use and delivered under Sterile State. Irrigation is intended to cool the clinical site and rinse the fragments such as bone or teeth.

The Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: • Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; • Scaling applications, including: – Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; – Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; – Endodontics: All treatments for root canal reaming, irrigation, revision, filling, gutta-percha condensation and retrograde preparation; – Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

The Piezosurgery White uses ultrasonic energy to generate mechanical micro-vibration of the available insert tips designed with different morphologies/shapes to perform the dental procedures defined in its intended use. The Piezosurgery White consists of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard.

Piezosurgery Touch is a piezoelectric ultrasonic device, consisting of handpieces and associated tip inserts, intended for: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic, and surgical endodontic procedures; - Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; - Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning; - Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation: - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation. Piezosurgery White is a piezoelectric ultrasonic device, consisting of handpieces and associated tor: - Bone cutting, osteotomy, osteoplasty and drilling in a variety of oral surgical procedures, including implantology, periodontal surgery, surgical orthodontic and surgical endodontic procedures; - Scaling applications, including: - Scaling: All general procedures for removal of supragingival and interdental calculus & plaque deposits; - Periodontology: Periodontal therapy and debridement for all types of periodontal diseases, including periodontal pocket irrigation and cleaning: - Endodontics: All treatments for root canal reaming, irrigation, filling, gutta-percha condensation and retrograde preparation: - Restorative and Prosthetics: Cavity preparation, removal of prostheses, amalgam condensation, finishing of crown preparations and inlay/onlay condensation.

The Piezosurgery Touch and Piezosurgery White use ultrasonic energy to generate mechanical microvibrations of the available tip inserts to perform the dental procedures defined in its intended use. They consist of a table-top unit (console) containing the irrigation delivery system, the internal electric power supply, the ultrasonic generator, and the control keyboard. They also includes the piezoelectric ultrasonic handpiece and foot-pedal, both connected directly to the console by means cords, and a variety of insert tips designed with different morphologies/shapes to be used for different dental procedures, according to device's intended use. The table-top units use piezoelectric ultrasonic technology to generate mechanical micro-vibrations of the insert tip attached to the handpiece. A piezoelectric transducer, located inside the handpiece, and driven by the ultrasonic generator electronics, induces vibrations at ultrasonic frequencies in the insert tip. The ultrasonic generator electronics searches and locates the resonant frequency of the transducer/insert tip combination, which varies according to the geometry/morphology of the insert tip in use. The functional ultrasonic frequency of the device is between approximately 24 and 36 kHz. Each of the insert tips is available separately. The purpose of this 510(k) is to add additional insert tip designs to the PIEZOSURGERY TOUCH and PIEZOSURGERY WHITE to extend the number of insert tips already cleared for sale in the US under K122322 and K151248.

The Bonart Oral Surgery System is intended for use in oral surgery and dental implantology,

ARTeotomy ORAL SURGERY SYSTEM and ACCESSORIES (Model No. BIS)