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 o - Amalgam plugging o - · 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 t - Implant maintenance t
Device Story
SP NEWTRON Module is a piezoelectric ultrasonic scaling generator sub-assembly for integration into dental units. Device converts electrical energy into ultrasonic waves (28-36 kHz) via piezoelectric handpieces to induce cavitation at the tip. Used by dental professionals for scaling, restorative, endodontic, and periodontal procedures. Electronic control system automatically adjusts power output based on resistance encountered by the tip; ensures optimal performance and prevents handpiece overheating. Benefits include efficient deposit removal and safe sub-gingival work. Output is mechanical vibration of the scaling tip for clinical intervention.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and intended use identical to the predicate device.
Technological Characteristics
Piezoelectric ultrasonic generator; frequency range 28-36 kHz. Modular sub-assembly for dental units. Features electronic automatic power control system based on tip resistance. Includes various interchangeable tips. Materials and components are consistent with predicate device (K972026).
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.
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K033764
MAR - 1 2004
# 8 SMDA Summary of Safety and Effectiveness - "510(k) Summary"
- A. Submitter Information
SATELEC Z.I. du Phare, BP 216 17, Avenue Gustave Eiffel 33708 Merignac Cedex FRANCE
011 33 5 5634 0607 Telephone:
Pascal Dupeyron Contact Person: Requiatory Affairs
December 1, 2003 Date Prepared:
#### B. Device Identification
Piezoelectric Ultrasound Scaling Generator Common/Usual Name: Proprietary Name: SP NEWTRON Module
### C. Identification of Predicate Devices
The SP NEWTRON module is substantially equivalent to its predicate devices, SP 4055 and SP 4055 LUX Modules (K972026) from SATELEC previously cleared and currently marketed.
#### D. Device Description
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:
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- 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.
## E. Substantial Equivalence:
The technical characteristics of the SP NEWTRON are almost identical to those of the SATELEC SP 4055 and SP 4055 LUX Modules. Differences that exists between the above systems relating to technical specifications, materials, physical appearance, and control systems are minor and do not affect the relative safety or effectiveness of the SP NEWTRON relative to the SP 4055 and SP 4055 LUX Modules.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem that resembles an abstract caduceus or a bird-like figure with three curved lines representing wings or feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR - 1 2004
Mr. Pascal Dupeyron Regulatory Affairs SATELEC Z.l. Du Phare, BP 216 17. Avenue Gustave Eiffel 33708 Merignac Cedex. FRANCE
Re: K033764
Trade/Device Name: SP NEWTRON Module Regulation Number: 21 CFR 872.4850 Regulation Name: Ultrasonic Scaler Regulatory Class: II Product Code: ELC Dated: December 1, 2003 Received: December 2, 2003
Dear Mr. Dupeyron:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Dupeyron
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Clive Li, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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33764
# Indications for Use
510(k) Number (if known): K033764
Device Name: SP Newtron Module
Indications For 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 o
- Amalgam plugging o
- · 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 .
Prescription Use
- Treatment of periodontal pockets .
×
- Treatment of furcations .
- Maintenance therapy t
- Implant maintenance t
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kein Muely for MSR
(Division Sign-Off)
Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
51D(k) Number:
Page 1 of
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
