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510(k) Data Aggregation
K Number
K233922Device Name
SP NEWTRON CAN-A; MODULE NEWTRON CAN-A EMB; SUPPORT XINETIC; NWT CAN SLIM LED CORD G3 SHORT; NWT CAN SLIM LED CORD G3 LONG
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2024-03-11
(89 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Scaling:
- Interdental junction treatment
- Tooth neck and subgingival treatment
- Treatment of large deposits
- Treatment of coating and tobacco stains
- Interproximal treatment
- Prosthesis conservative/restorative:
- Inlay/onlay condensation
- Amalgam plugging
- Loosening prostheses (bridge, crown, post, pivot ... )
Endodontics:
- Canal preparation
- Canal cleaning
- Canal filling
- Gutta percha condensation
- Treatment resumption
- Retro surgery
- Micro retro surgery
- Surface smoothing after burring
Periodontics:
- Root planning
- Initial therapy
- Treatment of periodontal pockets
- Treatment of furcations
- Maintenance therapy
Device Description
The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System. The NEWTRON CAN A Module contains an Embedded Software. The NEWTRON CAN A Module is an Ultrasonic Control Module intended to be integrated in a Dental Delivery System manufactured by the American Company named A-DEC. The A-DEC Dental Delivery System provides different function to the NEWTRON CAN A Module such as Ultrasonic Power Setting, Light Command through a communication frame. The communication frame is designed and imposed by A-DEC, the Manufacturer of the Dental Delivery System. The values of Ultrasonic Power Setting and the Light Command are coded and communication frame. Ultrasonic Power Setting and the Light Command are driven by the user with a touch pad embedded in the A-DEC Dental Delivery System. The only parameters of the NEWTRON CAN A Module that can be modified by the A-DEC Dental Delivery System are the values of Ultrasonic Power Setting and the Light Command. The NEWTRON CAN A Module converts a low voltage Power Supply provided by the A-DEC Dental Delivery System into an Ultrasonic Electric Signal. The NEWTRON CAN A Module is intended to be used in combination with a SATELEC Dental Ultrasonic Handpiece and a SATELEC range of Dental Tips. The electrical signal emitted by the NEWTRON CAN A Module supplies the Dental Ultrasonic Handpiece equipped with SATELEC Dental Tip. The amplitude of the ultrasonic micro-vibrations depends on the electrical Signal provided by the NEWTRON CAN A Module (amplitude). The SATELEC Dental Ultrasonic Handpiece is connected to the Dental Delivery System via a Handpiece cord. Mechanical micro- vibrations are transmitted to a Dental tip attached to the end of the SATELEC Dental Ultrasonic Handpiece.
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K Number
K131906Device Name
SCANWAVE PEN (WITH LIGHT GRAY CORD), SCANWAVE PEN (WITH MEDIUM GRAY CORD), SCANWAVE PEN (WITH DARK GRAY CORD), SCANWAVE
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2014-04-11
(289 days)
Product Code
EBZ, 804
Regulation Number
872.6070Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
SCANWAVE PEN is a source of illumination for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm.
Device Description
SCANWAVE PEN is a Dental Curing Light. More precisely, SCANWAVE PEN is a source of illumination used for the polymerization of light-curing dental materials curing in the wavelength range of 390 nm - 505 nm. SCANWAVE PEN is equipped with a LED (Light Emitting Diode) which permit to polymerize a large range of dental materials present on the market. SCANWAVE PEN is an Electro-medical Device. SCANWAVE PEN is compatible with only ADEC Dental units. The Handpiece contains the electronic command board, the power board and the light source. The rigid protection shield to the Handpiece reduces the light propagation outside the initial site. This accessory is used to protect the eyes of the patient and the user during the Curing Light polymerization act. The O.E.M. Module is a power supply module intended to deliver the electrical source needed for the Handpiece functioning. The O.E.M. Module is integrated in an ADEC Dental Unit. The User Manual contains all needed information for a correct using (description, safety aspects, problems, cleaning, disinfecting and sterilization procedures).
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K Number
K132322Device Name
NEWTRON P5 XS B.LED
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2014-03-11
(229 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosiblesis.
Device Description
The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).
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K Number
K132267Device Name
NEWTRON P5, NEWTRON P5 B.LED
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2014-03-10
(231 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
This medical device is intended for prophylaxis, including scaling, for periodontics, for endodontics, and for preservation and restoration dentistry, including prosthesis.
Device Description
The Satelec New Device is a Dental Ultrasonic Generator. The Satelec New Device uses Piezoelectric Technology. The Satelec New Device uses a Satelec Dental Piezoelectric Handpiece (NEWTRON SLIM or NEWTRON SLIM B.LED). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with Predicate Devices (K050895, cleared April 20, 2005 and K113430, cleared February 23, 2012).
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K Number
K131151Device Name
ENDOCENTER
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2014-01-16
(268 days)
Product Code
ELC, EKX
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
For use by dentists in standard endodontic procedures using rotary endodontic files or reciprocating endodontic files or use by dentists in periodontics, endodontics, scaling, prosthesis procedures with ultrasonic tips.
Device Description
The ENDO CENTER is an electric motor-driven handpiece combined with an ultrasonic scaler intended for root canal preparation procedures in endodontic industry. In ULTRASONIC mode, the device is able to drive piezo-electric resonator for root canal treatment at selectable power and fixed frequency . In ROTATING mode, the device is able to drive electrical micromotor for rotary files for root canal treatment at selectable speed and torque. In RECIPROCATING, mode, the device is able to drive electrical micromotor for reciprocating files for root canal treatment at selectable speed and rotational angle. The New Device is a combination of two existing devices already in consolidated use in endodontic field.
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K Number
K131997Device Name
NEWTRON BOOSTER
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2013-11-26
(151 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The medical device is used in association with a dental ultrasound handpiece to which an ultrasound instrument is attached. It is designed for the treatment of scaling (prophylaxis), periodontics, endodontics and prosthesis (preservation and restoration dentistry).
Device Description
The Satelec New Device is a Dental Ultrasonic Generator. The Sateler New Device uses Piezoelectric Technology.The Satelec New Device uses a Satelec Dental Piezoelectric Plezonecht - Technology. The Satelec New Device can use the same Handpiece Harroplece (NEWTRON OElin). In Option the School (K050895, cleared April 20, 2005). The Satelec New Device is designed to be used with Satelec Dental Tips previously cleared with The Satelec New Device is Gesigned to be association of the St. 430, cleared February 23, 2012) or other new Satelec Dental Tips.
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K Number
K113430Device Name
PROULTRA PIEZO ULTRASONIC
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2012-02-23
(94 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator intended for use with The Frookia , lead on for, scaling, periodontics, prosthesis and endodontic Dental Applications.
Device Description
ProUltra Piezo Ultrasonic is a Dental Ultrasonic Generator.
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K Number
K111623Device Name
I-ENDO DUAL
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2012-01-10
(214 days)
Product Code
EBW
Regulation Number
872.4200Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
I-Endo Dual is indicated for use by dentists in standard endodontic procedures using endodontic files and endodontic drills.
Device Description
The I ENDO DUAL is an electric motor-driven handpiece intended for root canal preparation procedures in the endodontic industry. It works in both reciprocating mode and continuous rotation.
The motor allows the dentist to program 10 settings of their choice for speed and torque control in rotating mode and to program 10 setting of their choice for speed and angles in reciprocating mode.
The device consists of a control unit with an LCD screen for selection of settings. A foot pedal is connected to the control unit so the dentist can selectively activate and deactivate the motor.
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K Number
K072030Device Name
IMPLANT CENTER
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2007-11-19
(118 days)
Product Code
DZI
Regulation Number
872.4120Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The intended use of the Satelec Implant Center is to supply utilities to and serve as a base for dental tools and accessories for use by qualified dental practitioners.
Device Description
The Satelec Implant Center is a dental operative unit that supplies utilities to and serves as a base for dental tools and accessories for use by qualified dental practitioners.
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K Number
K071424Device Name
PMAX NEWTRON XS
Manufacturer
SATELEC-ACTEON GROUP
Date Cleared
2007-08-24
(93 days)
Product Code
ELC
Regulation Number
872.4850Why did this record match?
Applicant Name (Manufacturer) :
SATELEC-ACTEON GROUP
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pmax Newtron XS is intended for use by qualified dental practitioners in the following dental applications:
Periodontics
Endodontics
Scaling
Prosthesis
Device Description
The Pmax Newtron XS is an ultrasonic scaler for use by qualified dental practitioners in the four conventional dental applications of prophylaxis, periodontics, endodontics, and prosthesis.
The Pmax Newtron XS device uses piezoelectric ultrasound technology to generate mechanical microvibrations for ultrasonic scaling, with minimal trauma to soft tissue.
The Pmax Newtron XS™ function offers four utilization modes at pre-set ultrasound power settings. The power of the ultrasound can be finely adjusted by the user.
Range: Green, Ultrasound power: Low, Procedure: Periodontics mainly
Range: Yellow, Ultrasound power: Medium, Procedure: Endodontics mainly
Range: Blue, Ultrasound power: High, Procedure: Prophylaxis mainly
Range: Orange, Ultrasound power: Very high, Procedure: Prosthesis or Specific treatment modalities
Liquid irrigation is provided by two 300 mL self-contained solution tanks and the Newtron LED handpiece provides light and air functions. The light is provided by a light ring consisting of high-performance light-emitting diodes (LED) in the handpiece and air is delivered to the handpiece for air irrigation through connection of the control unit to the user's dental surgery's medical quality filtered air distribution system.
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