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510(k) Data Aggregation
K Number
K080365Device Name
MORCE POWER PLUS AND VARIOCARVE MORCELLATOR
Manufacturer
NOUVAG AG
Date Cleared
2009-06-29
(504 days)
Product Code
HET
Regulation Number
884.1720Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Morce Power Plus morcellator is intended for use in operative laparoscopy, including laparoscopic general surgical procedures and laparoscopic gyrocological procedures to morcellate and remove tissue.
The VarioCarve morcellator is intended for morcellating and extracting tissue (e.g. removing myomata or the uterus) during laparoscopic procedures in general surgery and gynecology.
Device Description
The Morce Power Plus / VarioCarve is the drive control unit for the morcellator. With a cutting blade on the distal end, a rotating cylindrical tube is inserted in the abdominal cavity.
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K Number
K081191Device Name
TCM ENDO 20
Manufacturer
NOUVAG AG
Date Cleared
2008-08-07
(101 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TCM Endo 20 is a dental root treatment device for enlarge the root canal with a rotating, high elastic file.
Device Description
The TCM Endo 20 is a transportable, cord connected equipment, provided with a plastic enclosure which has two connection ports for the footswitch and the electronic motor. It is a microprocessor controlled electronic motor system which controls the rotational speed and the torque of the motor. The rotational speed is constant until the torque reaches the adjusted level. In order to protect the rimmer, you can choose between two torque controlling modes -the Automatic Limiter (AL) and the Automatic Reverse (AR) mode. The electronic motor has a standard E-type handpiece adapter that accepts any E-type contra angle and handpiece (E-fitting).
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K Number
K071588Device Name
DISPENSER DP 20
Manufacturer
NOUVAG AG
Date Cleared
2007-11-26
(168 days)
Product Code
FRN
Regulation Number
880.5725Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Dispenser DP 20 is intended for the general surgical fluid irrigation and infiltration under the direct control of a physician. The infiltration pump is not intended for intravascular infusion of fluids.
Device Description
The principle of operation and technology incorporated in the Dispenser DP 20 are equivalent to peristaltic irrigation systems, which use peristalsis-type action to move fluid through a tube by alternating mechanical squeezing of fluid-filled tubing with a roller. As with all peristaltic pumps, the Dispenser DP 20 contacts only the tubing and never directly contacts the fluid, thus fluid sterility cannot be compromised by the pumping action. Sterility: Tubing set; disposable with plug-in cannula, sterile, length 4 m
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K Number
K042822Device Name
TCM ENDO V, MODEL 1534
Manufacturer
NOUVAG AG
Date Cleared
2004-12-22
(71 days)
Product Code
EKX
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TCM Endo V is a dental root canal measurement and treatment device that can measure the length of the root canal and enlarge the canal while monitoring the position of the file tip inside the canal.
Device Description
The TCM Endo V is a transportable, cord connected, microprocessor-controlled endodontic device with Apex Locator. It is provided with a plastic enclosure which has four electrical connection ports for the detachable power supply cord, the foot-control, the micro-motor and the reference electrode (lip connector). The Apex Locator measures the distance between file tip and Apex. If a minimum distance is preselected, the selected auto-control mode is activated thus ensuring that the minimum distance is reached. The speed is held constantly under all circumstances until the maximum adjusted torque limit is reached. The Automatic Torque Control (ATC) protection mode ensures that no file breakage occurs. Once the preselected torque limit has been reached, the motor will immediately reverse for one revolution, then returns to forward direction. This ensures a fast and effective root canal preparation. The following parameters can be set by the user; - mains voltage (100V/115V/230V) - rotational speed (150-2000 rpm) - "Apex adjust" (-1 to 0) - automatic torque limitation "ATC" (5-40Nmm) - "Auto control" mode ("Auto Slow / Down", "Auto Reverse"; "Auto Stop") - micro-motor ON/OFF "Motor"
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K Number
K042943Device Name
NOUVAG AG - VACUSON 40 AND VACUSON 60
Manufacturer
NOUVAG AG
Date Cleared
2004-12-17
(53 days)
Product Code
BTA
Regulation Number
878.4780Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Vacuson 40 and Vacuson 60 are intended as extraction suction units for vacuum extraction, aspiration and removal of fluids, and infectious material from wounds or tissue either during surgery or at the patient 's bedside.
Device Description
Every model has at least one suction jar with overflow safety device, bacterial filter and optional a castered troiley. The optional foot switch can be used to activate the suction opinonal a castered a most can be continuously regulated by a valve and monitored through the manometer.
Vacuson 40 and Vacuson 60 are different in the maximum suction flow rate.
The Vacuson 40 has a built-in piston pump with the name "P40". The maximum suction flow rate for the Vacuson 40 Device is specified with 40 litres/min.
The Vacuson 60 has a built-in piston pump with the name "P70". The maximum suction flow rate for the Vacuson 60 Device is specified with 60 litres/min.
Sterility:
Suction tube, Suction jars with jar lids: Sterility by user up to 134°C.
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K Number
K042434Device Name
MICRO-MOTORSYSTEMS MD20, SEM2, HIGHSURG 20 & DT55
Manufacturer
NOUVAG AG
Date Cleared
2004-11-03
(56 days)
Product Code
DZI, ERL, HBC, HBE
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K022505Device Name
CONTRA-ANGLE, MODELS 1059, 5050, 5051, 5055, 5056, 5057, 5059, 5060, 5061, 5062, 5063, 5064, 5065, 5066, 5067, 5068,
Manufacturer
NOUVAG AG
Date Cleared
2003-10-01
(429 days)
Product Code
EGS
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Indications are widespread in the field of Surgery, Implantology and Endodontic treatment.
- Surgery: 1059, 5050, 5051, 5055, 5056, 5060, 5062, 5063, 5068, 5070, 5075
- . Endodontic treatment: 5057, 5059, 5061, 5066, 5067, 5069, 5071, 5076
- . Speed Increaser Contra-Angle: 5081 The device is intended for use where high speed such as 200'000 rpm is required in general dentistry with or without use of coolant; such as cutting a tooth for cavity and/or crown preparation and finishing, cuttin and/or finishing of dentures, denture bases, crowns, inlays and metal plates
All devices are driven by an electric micromotor handpiece that has the ISO-3964 Coupling.
Device Description
All mentioned NOUVAG Contra-Angle Attachments Dental are attachments for surgical drive units. They are designed to transmit rotational movement of the motor axle of such drive units to the shank of a bur which will be inserted into the output end of the handpiece.
For this application, all these Contra-Angle Attachments contain a coupling part fittable to all surgical motors with a coupling according to ISO 3964.
The output end of the Contra-Angle Attachments contains chuck systems for accommondation of standardized bur shanks. All mentioned NOUVAG Contra-Angle Attachments Dental are designed for burs according to ISO 1797 shank-type 1.
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K Number
K013185Device Name
TCM ENDO III
Manufacturer
NOUVAG AG
Date Cleared
2001-11-28
(65 days)
Product Code
EFA
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation.
Device Description
The TCM Endo III is an AC-powdered endodontic unit consisting of a controller console, foot pedal and motor intended to drive dental handpieces during root canal preparation. The motor has a maximum 1:1 drive output of 16,000 Rpm's. The unit is supplied with either a 115V or 230V power cord. The entire motor assembly of the TCM Endo III is autoclavable.
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K Number
K000710Device Name
MD 10, SEM, SM 12, CBM
Manufacturer
NOUVAG AG
Date Cleared
2000-05-11
(70 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Device Description
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K Number
K981679Device Name
TCM 3000 AND TCM ENDO
Manufacturer
NOUVAG AG
Date Cleared
1999-02-09
(272 days)
Product Code
EFB
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
NOUVAG AG
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Nouvag AG's ("Nouvag") TCM 3000 and TCM Endo is a microprocessorcontrolled dental hand piece with controlled electric motor-torque. The TCM 3000 and TCM Endo is intended to be used for dental drilling and tightening of the various types of screws during dental implantation and microsurgery.
Device Description
The TCM 3000's and TCM Endo's primary components are (1) a console; (2) a motor; (3) a microprocessor; (4) a foot pedal; and (5) an electric cord and plug. The TCM 3000 and TCM Endo is not supplied with dental drills or contra-angles or contra-angles torque wrenches, which are also called dental hand pieces. The Micromotor has a standard E-Type coupling that will fit any E-Type hand pieces and contra-angles.
The console houses the microprocessor and the motor. The buttons for setting the motor speed, contra-angle reduction ratio, motor torque are located on the front panel of the console. The buttons that may be used to start and stop the motor and change the cut-direction of the drill also are located on the front panel. The port connections for the contra-angles and the foot pedal and the main power switch are located on the back of the console.
A lever is located on the foot pedal for starting and stopping the motor. For the second version of the foot pedal the lever also can adjust the motor speed. The TCM 3000/Endo contains an audible alarm that sounds when the drill is turning in the reverse- cut direction.
The TCM 3000/Endo requires an AC current of 115V or 230V. An electrical cord, which is intended to be plugged into a standard electrical outlet, is attached to the back of the console.
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