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510(k) Data Aggregation
K Number
K213477Device Name
Root ZX3
Manufacturer
J. Morita USA, Inc.
Date Cleared
2022-08-03
(278 days)
Product Code
EKZ, LQY
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Root ZX3 device is a dental device with an apex locating function and an optional electrosurgical function and is composed of the aforementioned corresponding modules.
The apex locating function of Root ZX3 device is used for root canal measurement and working length determination.
The electrosurgical function is used for the following dental procedures: gingival incision and excision, gingivoplasty, gingivectomy, hemostasis, pulpotomy as an adjunct to root canal therapy, and excision of intraoral lesions. It is also used for the ablation of pulp, dental filling material (e.g. gutta-percha) and tissue in/around root canals as an adjunct to root canal therapy, after determining the tip position of the active electrode by apex location.
Device Description
The Root ZX3 device (also referred to by its model number RZX3) is a battery-driven apex locator with an optional dental electrosurgical unit, used in the oral cavity during dental procedures. This device has two modules: the main module is an apex locator module and the other is an electrosurgical module (high frequency [HF] module). The apex locator module is the basic module to which dental electrosurgical functions can be added by connecting the HF module.
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K Number
K071632Device Name
PERFECT TISSUE CONTOURING SYSTEM II
Manufacturer
COLTENE/WHALEDENT INC.
Date Cleared
2007-10-18
(126 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The PerFect® TCS II is intended to cut or remove soft tissue or to control bleeding during dental and periodontal surgical procedures in the oral cavity.
Device Description
PerFect® TCS II is an electrosurge unit designed to appeal to both the new and experienced user of electrosurgery. PerFect® TCS II can simplify and enhance the results of a variety of everyday procedures performed by virtually every dentist, including the control of bleeding, gaining access to caries and aesthetic contouring of gingiva.
The PerFect® TCS II is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The radio-frequency energy used by PerFect® TCS II is able to sever and coagulate tissue because it focuses the heat energy at the small, active electrode. While the active electrode remains cold, sufficient heat energy is generated in its path to sever and coagulate effectively.
The high-frequency energy focused at the active electrode returns to the electrosurge through the large dispersive electrode, which is placed on the back of the dental chair against the patient's back during use. The PerFect® TCS II has two output modes: "Cut" and "Coag." The operator can adjust the intensity of these modes. When the power output is adjusted properly, the electrode cuts without resistance, permitting an extraordinary degree of control and precision.
The PerFect® TCS II is designed to use the Strobex (predicate) handpiece electrodes. These handpiece electrodes have not changed in biocompatibility materials (stainless steel) or in the manufacturing process. In addition performance testing was conducted by UL that included functional testing of electrodes sterilized twenty times via the recommended cycle.
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K Number
K063468Device Name
THE FUGO BLADE FOR DENTISTRY
Manufacturer
MEDISURG LTD.
Date Cleared
2007-04-18
(153 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Fugo Blade system is intended for incision, excision, ablation, vaporization and hemostasis of oral soft tissue e.g. excisional and incisional biopsies; exposure of unerupted teeth; fibroma removal; frenectomy and frenotomy; gingival troughing for crown impressions; gingiyoplasty: gingivectomy; gingival incision and excision; hemostasis; implant recovery; incision and drainage of abscess; leukoplakia; operculectomy; oral papillectomies; pulpotomy; pulpotomy as an adjunct to root canal therapy; reduction of gingival hypertrophy; soft tissue crown lengthening; secular debridement; treatment of aphthous ulcers; vestibuloplasty; biopsy incision and excision; and lesion (tumor) removal.
Device Description
The Fugo Blade for dentistry is an electrosurgical device that is powered by the electromagnetic (EM) energy from flashlight size batteries. This energy is conditioned, tuned (9.8+/- 2.0 x 106 Hz) and focused on a thin blunt cutting filament. Moreover, the EM energy from flashlight size (C cell) batteries is fed into a proprietary electronic network system which is activated by the surgeon with an on/off switch. This electronic system is fed EM energy from the battery energy supply source, then conditions it in a proprietary fashion and transfers it to the surgeon cutting filament. This column of EM energy is capable of reacting with tissue. This column of EM energy causes the molecular bonds in the tissue which come in contact with the EM field to ionize and thereby break apart, a condition that plasma physicists refer to as "plasma formation". In this way, the molecular lattice of the tissue is broken into micro-fragments, thereby creating an incision, excision, ablation, vaporization, and hemostasis of oral soft tissue.
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K Number
K052622Device Name
MACAN MODEL MC-4A DENTAL ELECTROSURGICAL UNIT
Manufacturer
MACAN ENGINEERING CO.
Date Cleared
2005-12-09
(77 days)
Product Code
EKZ, CLA
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Soft tissue management within the oral cavity to address the indications for incision, excision and ess of the success in and caff to comboof ties o Soft tissue managements in intra-oral soft tissue.
Device Description
The MC-4A dental electrosurgical unit is an AC powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended a controlled power of thissue or to control bleeding during surgery in the oral cavity. An electrical to our of the tip of the tip of the electrode into tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
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K Number
K050735Device Name
MC6A
Manufacturer
MACAN ENGINEERING CO.
Date Cleared
2005-05-23
(63 days)
Product Code
EKZ, CLA
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Soft tissue management within the oral cavity to address the indications for incision, excision and in the states in interested soft tissue. Soft tissue management while as a soft tissue.
Device Description
The Radiosurge MC6A device is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. The device is intended to cut or remove soft tissue or to control or cating and coughtang orcedures in the oral cavity. An electrical current passes through the tip of the blectrode into the tissue and, depending upon the operating mode selected, either cuts through soft tissue or coagulates the tissue.
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K Number
K023672Device Name
X O ODONTOSURGE 4
Manufacturer
XO CARE A/S
Date Cleared
2003-04-29
(179 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The X O Odontosurge 4 is intended for use in removing soft tissue and controlling bleeding in the oral cavity in all phases of dentistry, including prosthodontics, periodontics, endodontics, pedodontics, orthodontics, oral surgery, and routine restorative dentistry.
Device Description
The X O Odontosurge 4 is a high frequency electrosurgery unit that is comprised of the following three principal components: Control Box, Handpiece and Cord, and seven different Electrodes contained in a separate case. The X O Odontosurge 4 is compact and easily portable. The X O Odontosurge 4 is a reusable electrosurgical unit that is used to cut and to coagulate soft tissue during procedures in all disciplines of dentistry. There is no software utilized in the operation of the X O Odontosurge 4.
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K Number
K020080Device Name
BONART ART-E1 ELECTROSURGERY UNIT
Manufacturer
DIAGNOSTIC DATA, INC.
Date Cleared
2002-02-19
(41 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Bonart Co., Ltd. ART-E1 Electrosurgery Unit is intended for use in dental electrosurgery (electrosection), electrosection/electrocoagulation, and electrocoagulation for serious bleeding.
Device Description
Not Found
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K Number
K001560Device Name
ODONTOSURGE 3
Manufacturer
ODONTO-WAVE
Date Cleared
2000-08-24
(97 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K000768Device Name
WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
Manufacturer
WALLACH SURGICAL DEVICES, INC.
Date Cleared
2000-04-11
(33 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K982229Device Name
BI-DENT
Manufacturer
VALLEY FORGE SCIENTIFIC CORP.
Date Cleared
1998-08-13
(90 days)
Product Code
EKZ
Regulation Number
872.4920Why did this record match?
Product Code :
EKZ
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Valley Forge Bi-Dent Electrosurgical System is intended for the Dental Practitioner for the cutting and coagulation of oral tissue.
Device Description
The Valley Forge Bi-Dent Electrosurgical System is a Bipolar Surgical System. It is a Bipolar Coagulator/Cutting System with integrated irrigation. It incorporates the effectiveness and safety features of bipolar coagulation/cutting and irrigation packaged into one functional unit. Some of the effective safety features of the Bipolar Coagulator/Cutting System are: Bipolar Technology eliminates the need for grounding pads and the possibility of patient burns. Bipolar Cutting/Coagulation minimizes damage to adjacent tissue since the patient is no longer the return path for the electrical current. Bipolar Technology works at voltages approximately 1/10th the voltage required for monopolar technique. Localized Bipolar Cutting/Coagulation gives the surgeon precise control of the electric current at the tissue site. The System's patented waveform and exceedingly low Output Impedance provide superior Cutting/Coagulation and the absence of charring and sticking even in a dry field. Because of the high output impedance of monopolar and other bipolar systems, instruments short-out in an irrigated or bloody field. The Bipolar Coagulator/Cutting System offers an Irrigation Delivery System to keep tissue moist and cool during coagulation. Because of the System's ability to work in a wet field, tissue samples removed for biopsy are not charred or desiccated. Unlike monopolar systems, the Bipolar Coagulator/Cutting System provides smooth, progressive coagulation with precise flow-controlled irrigation. The System permits the physician to cut and coagulate in an Irrigated Field thereby minimizing heat build-up or thermal damage to adjacent tissues. The waveform parameters of the Bipolar Coagulator/Cutting System are programed for the smoothest, most gentle, precise and efficient coagulation and cutting of tissue during any surgical procedure.
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