The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Device Story
Paltop Narrow Implant is a single-use, endosseous, screw-type dental implant with an internal hexagonal connection; functions as a substitute for a natural tooth. Fabricated from titanium alloy (Ti-6Al-4V ELI); surface treated via sandblasting and acid etching. Used by dental professionals in clinical settings to support prosthetic devices (artificial teeth) in patients with narrow alveolar ridges or limited horizontal space between adjacent teeth/roots. Eliminates need for bone augmentation or orthodontic movement. Implant is placed surgically; provides support for prosthetic superstructures. Benefits include restoration of chewing function in anatomically constrained sites.
Clinical Evidence
No clinical data. Substantial equivalence supported by bench testing, including fatigue testing, corrosion resistance, surface analysis, biocompatibility evaluation, sterilization, and shelf-life validation.
Indicated for partially edentulous patients requiring dental implants in mandibular central/lateral incisor or maxillary lateral incisor regions where horizontal space is limited. Suitable for immediate loading if primary stability and appropriate occlusal loading are achieved.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
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Image /page/0/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a bold, modern font. Below the company name and logo is the tagline "With you to the TOP" in a cursive font.
510(k) SUMMARY
510(k) Number K | 3046 2
Applicants Name: Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 4 6271711 F +972 4 6275363
Contact Person: Tal Hammer-Topaz Quality, Regulatory & Clinical Manager Paltop Advanced Dental Solutions Ltd. Hashita 5 Industrial Park Caesarea 30889, Israel T +972 5 23 520050 F +972 4 6275363 Email: tal@paltopdental.com
AUG 27 2013
- February 18th, 2013 Date Prepared:
Trade Name: Paltop Narrow Implant
Classification Name: Implant, Endosseous, Root-form
Common usual name: Dental Implant
Medical Specialty: Dental
Product Code: DZE, NHA
- Device Class: Class II
- Regulation Number: 872.3640
- Review Panel: Dental Device Panel
Predicate Devices:
Paltop Narrow Implant is relying on the combination of the following predicate devices:
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Image /page/1/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth inside a circle on the left, followed by the word "PALTOP" in a bold, sans-serif font. A small circle with a degree symbol is located to the right of the "P". The text "With you to the TOP" is written in a cursive font below the logo.
- Paltop Dental Implant System (Paltop Advanced Dental Solutions Ltd.) cleared . under K112795; product code DZE, NHA (Implant, Endosseous, Root-Form).
- UNO Narrow Implant (MIS Implant Technologies Ltd.) cleared under K092555; . product code DZE, NHA (Implant, Endosseous, Root-Form).
- Osseospeed " Narrow (ASTRA Tech AB) cleared under K080396; product code . DZE,NHA (Implant, Endosseous, Root-Form)
# Intended Use / Indication for Use:
The Paltop Narrow Implant is indicated for use in surgical and restorative applications for placement in the mandibular central, lateral incisor and maxillary lateral incisor regions of partially edentulous jaws where the horizontal space is limited by the adjacent teeth and roots, to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. The Paltop Narrow Implant is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
#### Device Description:
Paltop Narrow Implants, as other implants available in the market, are essentially a substitute for a natural tooth. Paltop Narrow Implants, as other implants available in the market, are one and two stage endosseous screw type implant with internal hexagonal connection, intended for single use. As other implants available in the market, they are fabricated from titanium alloy, Titanium -6 Aluminum 4 Vanadium ELI alloy, according to ASTM F136-98, a biologically compatible material to vital tissue, and surface treated with sand blasting and acid etching.
The Paltop Narrow Implant is a suitable treatment option when the possibility of placing a standard implants is limited due to physical conditions, where the horizontal space is
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Image /page/2/Picture/0 description: The image shows the logo for Advanced Dental Solutions Ltd. The logo features a stylized tooth graphic on the left, followed by the word "PALTOP" in a modern, sans-serif font. Below the company name is the tagline "With you to the TOP" in a cursive font.
limited by adjacent teeth and roots, or in situations with a narrow alveolar ridge. By using a narrow implant the need for bone augmentation or orthodontic tooth movement can be avoided.
The Paltop narrow implants are 3.25mm-wide and are available in lengths of 10mm, 11.5mm, 13mm and 16mm.
# Substantial Equivalence:
The proposed Paltop Narrow Implants have similar indications for use, technological characteristics, mode of operation and performance specification as the predicates MIS Implants and Astra-Tech Implants. The proposed devices have the same intended use as the predicates and are placed using the same methodology as the predicate devices. Both the proposed and predicate devices function in the same manner providing support for prosthetic devices in the upper or lower jaw.
| | PALTOP Narrow | PALTOP Dental | MIS UNO Narrow | Astra Tech |
|-----------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | lmplants | Implant System | lmplant | OsseoSpeed Narrow |
| K# | | Cleared under | Cleared under | Cleared under |
| | | K#112795 | KHO92555 | K#080396 |
| Product Code | DZE, NHA | DZE, NHA | DZE, NHA | DZE, NHA |
| Manufacturer | Paltop Advanced | Paltop Advanced | MIS Implant | Astra Tech AB |
| | Dental Solutions Ltd. | Dental Solutions Ltd. | Technologies Ltd. | |
| Intended Use/ | The Narrow Implant is | The Paltop Dental | The UNO Narrow | The OsseoSpeed |
| Indications for | indicated for use in | lmplant System is | implant is indicated | Narrow is intended to |
| Use | surgical and | indicated for use in | for use in surgical and | be used to replace |
| | restorative | surgical and | restorative | missing masticatory |
| | applications for | restorative | applications for | functional units |
| | placement in the | applications for | placement in the | (teeth) in single or |
| | mandibular central, | placement in the | mandibular central, | multiple unit |
| | lateral incisor and | bone of the upper or | lateral incisor and | applications within |
| | maxillary lateral | lower jaw to provide | maxillary lateral | the mandible or |
| | incisor regions of | support for prosthetic | incisor regions of | maxilla. The device |
| | partially edentulous | devices, such as | partially edentulous | may be equally well in |
| | jaws where the | artificial teeth, in | jaws where the | single-stage or two- |
| | horizontal space is | order to restore the | horizontal space is | stage surgical |
| | limited by the | patient's chewing | limited by the | procedure. It is |
| | adjacent teeth and | function. The Paltop | adjacent teeth and | indicated for |
| | PALTOP Narrow | PALTOP Dental | MIS UNO Narrow | Astra Tech |
| | Implants | Implant System | Implant | OsseoSpeed Narrow |
| | roots, to provide | Dental Implant<br>System is indicated<br>also for immediate<br>loading when good<br>primary stability is<br>achieved and with<br>appropriate occlusal<br>loading. | roots,<br>jaw to provide<br>support for prosthetic<br>devices, such as<br>artificial teeth, in<br>order to restore the<br>patient's chewing<br>function. Mandibular<br>central and lateral<br>incisors must be<br>splinted if using two<br>or more φ3.0mm<br>implnats adjacent to<br>one another. . The<br>UNO Narrow Implant<br>is indicated for<br>immediate<br>implantation in the<br>extraction sites or<br>implantation in<br>partially healed or<br>completely healed<br>alveolar ridge<br>situations.<br>When a one stage<br>surgical procedure is<br>applied, the implant<br>may be immediately<br>loaded when good<br>primary stability is<br>achived and the<br>occlusal load is<br>appropriate. | immediate<br>implantation in<br>extraction sites or<br>implantation in<br>partially healed<br>alveolar ridge<br>situations. When a<br>one-stage surgical<br>approach is applied,<br>the implant may be<br>immediattely loaded<br>when good primary<br>stability is achived<br>and functional load is<br>appropriate. The<br>OsseoSpeed Narrow<br>product line shall be<br>used only to replace<br>maxillary lateral<br>incisors and<br>mandibular lateral<br>and central incisors.<br>The fluoride-modified<br>surface, though<br>having a fluoride ion<br>level far below the<br>needed for caries<br>prevention in theeth,<br>provides a favorable<br>substrate for bone<br>attachment and<br>osseointegration.<br>OsseoSpeed Narrow<br>is especially indicated<br>for use in soft bone<br>applications where<br>implants with other<br>implant surface<br>treatment may be<br>less effective.Because<br>initial stability may be<br>difficult to obtain in<br>Type IV bone,<br>immediate loading of<br>sungle tooth<br>restorations may not<br>be appropriate in<br>such situations. |
| Components | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures;<br>surgical instruments. | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; | Dental implants,<br>cover screws healing<br>caps; abutment<br>systems and<br>superstructures; |
| Clinical Data | Not applicable | Not applicable | Not applicable | Not applicable |
| | PALTOP Narrow<br>Implants | PALTOP Dental<br>Implant System | MIS UNO Narrow<br>Implant | Astra Tech<br>OsseoSpeed Narrow |
| Supplied<br>Sterile | Yes | Yes | Yes | Yes |
| Re-Use | No | No | No | No |
| Material<br>Composition | Titanium alloy | Titanium alloy | Titanium alloy | Titanium alloy |
| Surface<br>treatment | Sand Blasting and<br>Acid Etching | Sand Blasting and<br>Acid Etching | Sand Blasting and<br>Acid Etching | Fluride-modified<br>surface |
| Shape | Screw type | Screw type | Screw type | Screw type |
| Length | 10mm, 11.5mm,<br>13mm, 16mm | 8mm, 10mm,<br>11.5mm, 13mm,<br>16mm | 10mm, 11.5mm,<br>13mm, 16mm | 11mm, 13mm, 15mm |
| Diameters | 3.25mm | 3.75mm, 4.2mm,<br>5.0mm | 3.0mm | 3.0mm |
| Abutments | Straight and up to 20° | Straight and up to 25° | Straight and up to 20° | Straight and up to 20° |
| Material<br>Composition of<br>Abutments | Titanium al…
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.
