(90 days)
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 ... )
Endodontia:
- Canal preparation
- Canal cleaning
- Canal filling
- Gutta percha condensation
- Treatment resumption
- Retro surgery
- Micro retro surgery
- Surface smoothing after burring
Periodontia:
- Root planing
- Initial therapy
- Treatment of periodontal pockets
- Treatment of furcations
- Maintenance therapy
- Implant maintenance
The SP NEWTRON is a multi-purpose Piezoelectric Ultrasonic Scaling Generator sub-assembly which is an upgraded generation of the SP 4055 and SP 4055 LUX Modules from SATELEC that received 510(k) clearance for dental applications (K972026) on July 9, 1997. The SP NEWTRON maintains all the functions and the main components of the SP 4055 and SP 4055 LUX Modules. It is a stand-alone sub-assembly manufactured by SATELEC, all with the same components and materials used in the manufacture of the original SP 4055 and SP 4055 LUX Modules products, which can be used in standard dental units. The indented use, technical performance, and clinical indications are identical to those of their predicate devices, the SP 4055 and SP 4055 LUX Modules (K972026).
The SP NEWTRON module is a multi-purpose ultrasonic generator to be marketed as a modular sub-assembly to OEM manufacturers of dental units. Each module is shipped with three standard tips, (# 1, # 2 and # 10P) but can be used with a variety of optional tips with up to 70 different models. According to clinical indications, the SP NEWTRON offers 3 setting ranges: scaling, prosthesis conservative/restorative, ultrasonic endodontic treatment, and ultrasonic periodontal treatment.
As the ultrasonic waves are produced by piezoelectricity, the SP NEWTRON hand pieces give off very little heat, making it possible for surgeons to perform both periodontal work (sub-gingival work at low power, where the absence of overheating is vital), as well as loosening (requiring high power, but without the unpleasant side-effect of a hot hand piece).
The SP NEWTRON, similar to its predicate devices, SP 4055 and SP 4055 LUX Modules (K972026) from SATELEC, operates from the action of cavitation, following the efficient propagation of ultrasound signals in a frequency spectrum comprised between 28 and 36 kHz.
The electronic automatic control system has the capability to adjust power instantaneously in function of the resistance encountered by the tip, and varies with hand-piece and tip frequency so as to optimize power output.
This 510(k) summary (K033764) describes a piezoelectric ultrasonic scaling generator called the "SP NEWTRON Module."
The key takeaway is that the SP NEWTRON Module is found substantially equivalent to its predicate devices, SP 4055 and SP 4055 LUX Modules (K972026), based on their identical intended use, technical performance, and clinical indications. There is no discussion of a specific study with acceptance criteria and device performance results in the provided document. The 510(k) process for this device relies on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting new clinical study data against defined acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria, study details, and data provenance cannot be directly extracted from this document, as they are not applicable to a submission based on substantial equivalence to an existing device without new clinical claims.
However, I can provide information based on the assertion of substantial equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance (Implied by Predicate Equivalence) |
|---|---|
| Safety: Device is as safe as predicate devices. | SP NEWTRON Module is as safe as SP 4055 and SP 4055 LUX Modules. "Differences... are minor and do not affect the relative safety..." |
| Effectiveness: Device is as effective as predicate devices for all stated indications. | SP NEWTRON Module is as effective as SP 4055 and SP 4055 LUX Modules. "The indented [sic] use, technical performance, and clinical indications are identical..." and "Differences... are minor and do not affect the relative... effectiveness..." |
| Technical Characteristics: Similar to predicate devices, especially regarding ultrasonic wave generation, frequency spectrum, and automatic control system. | Operates via piezoelectricity, similar to predicates. Frequency spectrum between 28 and 36 kHz, similar to predicates. Electronic automatic control system adjusts power instantaneously based on resistance, similar to predicates. |
| Intended Use: Identical clinical applications (scaling, endodontic, periodontal treatments, etc.). | Identical intended use as predicate devices, covering scaling, prosthesis work, endodontia, and periodontia as listed in the Indications for Use. |
| Materials and Components: Same or equivalent materials and components as predicate devices. | Manufactured with "the same components and materials used in the manufacture of the original SP 4055 and SP 4055 LUX Modules products." |
2. Sample Size Used for the Test Set and the Data Provenance
Not applicable for this 510(k) submission. No new clinical test set or study data is presented to prove specific performance against acceptance criteria. The claim of substantial equivalence is based on engineering and functional comparison to the predicate device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. No new test set or ground truth establishment relevant to specific performance metrics is discussed.
4. Adjudication Method for the Test Set
Not applicable. No test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-assisted device, nor does the submission contain an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable in the context of a new study proving performance against acceptance criteria. The "ground truth" for this submission is the established safety and effectiveness of the predicate devices as legally marketed.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm requiring a training set.
Summary of the 510(k) Approach for K033764:
This submission leverages the concept of substantial equivalence. Instead of conducting new clinical trials or extensive performance studies with specific acceptance criteria, SATELEC demonstrated that their SP NEWTRON Module shares the same intended use, technical characteristics, and principles of operation as legally marketed predicate devices (SP 4055 and SP 4055 LUX Modules). The minor differences highlighted (technical specifications, materials, physical appearance, and control systems) were asserted not to affect the safety or effectiveness of the device. The FDA's clearance indicates agreement with this assertion, allowing the device to predicate on the established safety and effectiveness of the earlier devices.
§ 872.4850 Ultrasonic scaler.
(a)
Identification. An ultrasonic scaler is a device intended for use during dental cleaning and periodontal (gum) therapy to remove calculus deposits from teeth by application of an ultrasonic vibrating scaler tip to the teeth.(b)
Classification. Class II.