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Periodontics Endodontics Scaling Prosthesis Please refer to the attached listing for a complete description. Periodontics: - Root planing . - Initial therapy . - Treatment of periodontal pockets . - Treatment of furcations . - Maintenance therapy . - Implant maintenance . Endodontics: - Canal preparation . - Canal cleaning . - Canal filling . - Gutta percha condensation . - Treatment resumption . - Retro Surgery . - Micro Retro Surgery . Scaling (prophylaxis): - 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…) .

The SUPRASSON P5 NEWTRON is a multi-purpose piezoelectric ultrasonic generator: it is an upgraded generation of the SUPRASSON P5 Booster Piezoelectric Ultrasonic Scaling Generators from SATELEC which received 510(k) clearance for dental applications (K961158) on May 23, 1996, including the technology of the SP NEWTRON module which received 510(K) clearance for dental applications (K033764) on March 1, 2004. The SUPRASSON P5 NEWTRON maintains all the functions and the key components of the SUPRASSON P5 Booster and SP NEWTRON Module; it is a stand-alone device manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SUPRASSON P5 Booster and SP NEWTRON module. The intended use, technical performance, and clinical indications are equivalent to those of their predicate devices, the SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K033764). The SUPRASSON P5 NEWTRON consists of three main components: the ultrasonic handpiece instrument, the control panel case, and the footswitch. The ultrasonic handpiece instrument (cleared by FDA - K033764) is held in the physician's hand, but it can also be stored in the holder located onto the case. The handpiece is connected to the control panel case via a fixed electrical cable connection.

The provided text does not contain information about acceptance criteria for a device, nor does it detail a study that proves a device meets such criteria.

The document is a 510(k) summary for the "SUPRASSON P5 NEWTRON" piezoelectric ultrasound scaling generator, seeking FDA clearance. It describes:

• Submitter Information: SATELEC, France.
• Device Identification: SUPRASSON P5 NEWTRON, an ultrasonic scaler.
• Predicate Devices: SUPRASSON P5 Booster (K961158) and SP NEWTRON Module (K0033764). The new device is stated to be substantially equivalent to these previously cleared devices.
• Device Description: A multi-purpose piezoelectric ultrasonic generator, an upgraded generation maintaining functions and key components of the predicate devices. It consists of an ultrasonic handpiece instrument, control panel case, and footswitch.
• FDA Clearance Letter: Confirms the 510(k) clearance for the SUPRASSON P5 NEWTRON (K050895) based on substantial equivalence to predicate devices.
• Indications For Use: Specifies the dental applications in Periodontics, Endodontics, Scaling (prophylaxis), and Prosthesis (conservative/restorative).

The document focuses on establishing substantial equivalence to previously cleared devices for FDA marketing clearance, rather than presenting a performance study with acceptance criteria. Therefore, most of the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets) is not available in the provided text.

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