Tomas-pins are temporary, enossal anchorage elements for the treatment of tooth abnormalities in orthodontics and pre-prosthetics. To provide a fixed anchorage point for attachments of orthodontic appliances.
Device Story
Tomas-pin is a titanium grade 5 micro screw used as a temporary orthodontic anchorage device. The device features a hex head with slots for wire attachment and a retention channel for light-cured adhesive to secure orthodontic elements like arches and elastic bands. The screw is self-tapping but requires pre-drilling; it is inserted into the bone manually or mechanically. A soft tissue sleeve acts as a stop and protects surrounding tissue from irritation. The device is used in a clinical setting by an orthodontist to provide a stable anchor point, facilitating specific tooth movements. By providing a fixed point, it allows for more precise orthodontic force application, potentially improving treatment outcomes for tooth abnormalities.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Material: Titanium Grade 5 (ASTM). Design: Micro screw with hex head, retention channel, and soft tissue sleeve. Energy source: Manual or mechanical insertion. Connectivity: None. Sterilization: Supplied sterile in glass ampoules. Software: None.
Indications for Use
Indicated for orthodontic and pre-prosthetic patients requiring temporary, enossal anchorage for tooth movement. Used to provide a fixed anchorage point for orthodontic appliances.
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.
Predicate Devices
Nobel BioCare Implant Orthodontic Anchor System (K000643)
Jeil Medical Corporation Dual Top Anchor System Screws (K033767)
Submission Summary (Full Text)
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K042965
APR 1 5 2005
Dentaurum, Inc. 10 Pheasant Run • Newtown, PA 18940 USA Tel: 800-523-3946 • Fax: 215-968-0809 Dentaurum, Germany Postfach 440 • 75104 Pforzheim, Germany Tel: 011-49-7231-803511 · Fax: 011-49-7231-803340 Revised September 1, 2004 Contact: Dr. Thomas Lietz, R&D Director 510(k) Summary of Safety and Effectiveness
- Identification of the Device: (1) Proprietary-Trade Name: tomas-pin (Temporary Orthodontic Micro Anchorage System) ( Classification Name: Implant, Endosseous, Product Code DZE Common/Usual Name: Bone Screw
- Equivalent legally marketed devices: OsteoMed Orthodontic Screw System (K031936), Strauman Ortho (2) Equivalent legally mancies do roces. Socor Orthodontic Anchor System (K000643), and the Jeil Medical Corporation Dual Top Anchor System Screws (K033767) ...
- Indications for Use (intended use): Tomas-pins are temporary, enossal anchorage elements for the treatment of (3) tooth abnormalities in orthodontics and pre-prosthetics.
- Description of the Device: tomas-pin micro screws (orthodontic micro implant) are precisely manufactired, (4) Description of the Device. comas pin miero sorts (6), according to ASTM (American Society for Testing and anchorage elements made or grade 5 thankin (orrroo), and serve as a temporary anchor for various orthodontic tooth Materials). They are insorted into the best as follows: The head of the screw features hex type slots. movements. The tonias pill is constructions or thoughtic elements, such as arches, elastic bands and Reclaigular Wires are misetted to accomments on the tomas-pin with light cured adhesive. The adhesive should blackers. I relevably, the wire and retention head. The retention channel below the slots serves to securely anchor the adhesive to the tomas-pin. This also protects the soft tissue (cheek, lips, tongue) against irritation that could result from the screw head.
The thread of the tomas-pin is self-tapping but not self-drilling, which means that pre-drilling according to the I he tiread of the tomas-pin is ser tapping our it accommodate the tomas-pin. The tomas-pin is inserted and screwed into the bone by either manual or mechanical method.
The shoulder connection between the thread and soft tissue sleeve serves as a stop to prevent the tomas-pin I he silouius. Conficenon between the and seeve between the thread and retention head helps to prevent irritation between the borgiva and the tomas-pin, therefore, ensuring optimal hygiene.
Image /page/0/Figure/9 description: The image shows a medical implant with several labeled parts. The implant has a retention channel, a soft tissue sleeve, and a hex head. The implant also has a thread and a retention head with two slots.
Picture: Retention channel Thread Soft tissue sleeve Hex head Retention head with two slots
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The tomas-pins are delivered in glass sterile ampoules. The package contains labels that can be inserted into the patient's file for future reference and tracking.
The tomas-pins are available in the following sizes:
| Tomas-pin 08 (Order No. 302-008-00)<br>Length of screw body: 8mm<br>Diameter: 1.2mm | Tomas-pin 10 (Order No. 302-010-00)<br>Length of screw body: 10mm<br>Diameter: 1.2mm |
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Other product specifications can be found in the "Instructions for Use and Product Brochure".
Indications for Use: (ട)
To provide a fixed anchorage point for attachments of orthodontic appliances.
- Potential Adverse Affects and Complications: (Common to all devices of this type) (6)
- Poor bone formation, Osteoporosis, Osteolysis, Osteomyelitis, inhibited revascularization, or infection . Poor bone lormation, Osteoporosis, Ostobily of the device or premature loss of fixation with the bone, leading to nonunion.
- Migration, bending, fracture or loosening of the implant. .
- Metal sensitivity or allergic reaction to a foreign body. .
- Pain, discomfort or abnormal sensation, due to the presence of the device. .
- I am, disoomirers of assue response around the fracture site and/or the implant. .
- Necrosis of bone. .
- Inadequate healing. .
Apart from these adverse affects there are always possible complications of any surgical procedure such as, but not /spart from these adverse damage, and pain which may not be related to the implant.
## Safety and Effectiveness, comparisons to predicate devices: (7)
| Device Name | Nobel BioCare<br>Implant Orthodontic<br>Anchor System | OsteoMed<br>Orthodontic Screw<br>System | Jeil Medical Corp.<br>Dual Top Anchor<br>System Screws<br>(various models) | Dentaurum, Inc.<br>tomas-pin (Temporary<br>Orthodontic Micro<br>Anchorage System) |
|----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Classification<br>Name | Implant, Endosseous,<br>Product Code DZE | Implant, Endosseous,<br>Product Code DZE | Implant, Endosseous,<br>Product Code DZE | Implant, Endosseous,<br>Product Code DZE |
| Applicant | Nobel BioCare | OsteoMed | Jeil Medical Corp. | Dentaurum, Inc. |
| 510(K) Number | (K000643) | (K031936) | (K033767) | (this submission) |
| Material | Titanium | Titanium Alloy | Titanium Alloy<br>(ASTM F 136-98) | Titanium Grade 5<br>(ASTM) |
| Intended Use | This device is intended<br>to provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances<br>to facilitate the<br>orthodontic movement<br>of teeth. It is used<br>temporarily and is<br>removed after<br>orthodontic treatment<br>has been completed. | This device is used as<br>an anchorage for<br>orthodontic treatment<br>in the mouth. | This device is intended<br>to provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances<br>to facilitate the<br>orthodontic movement<br>of teeth. It is used<br>temporarily and is<br>removed after<br>orthodontic treatment<br>has been completed. | This device is intended<br>to provide a fixed<br>anchorage point for<br>attachment of<br>orthodontic appliances<br>to facilitate the<br>orthodontic movement<br>of teeth. It is used<br>temporarily and is<br>removed after<br>orthodontic treatment<br>has been completed. |
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| | Screws are intended<br>for single use only. | | Screws are intended<br>for single use only. For<br>use in adults over the<br>age of 12. | Screws are intended for<br>single use only. |
|----------------------|---------------------------------------------|--------------------------------------------|-----------------------------------------------------------------------------------------|---------------------------------------------|
| Single Use? | YES | YES | YES | YES |
| Supplied<br>Sterile? | No comment | Non sterile, steam<br>sterilize before use | Non sterile, steam<br>sterilize before use | Sterile |
- Conclusion: In all reports, the tomas-pin (Temporary Orthodontic Micro Anchorage System) is the equivalent (8) Conclusion: In an reports, the tonlas-pill (Temporary Orthoterials and have similar dimensions and of currently marked devices. They are identical to those of predicate devices . This devices manufactured characteristics. Potential adverse are identical in this kind of bone screw. Similar device made from titanium in the device is from fitanium, grade > (ASTM) that is used guice are manufactured and solus cound the world. This device is ttianum alloy (AS I M 136-98) to mis uevice and function to the products on the table above. These devices are certified by the notified body for CE.
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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol consisting of three curved lines that resemble a human figure with outstretched arms.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
## APR 1 5 2005
Dr. Thomas Lietz R&D Director Dentaurum, Incorporated 10 Pheasant Run Newtown, Pennsylvania 18940
Re: K042965
Trade/Device Name: TOMAS Pin Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: April 6, 2005 Received: April 8, 2005
Dear Dr. Lietz:
We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your becalled by the device is substantially equivalent (for the relerenced above and have accommissure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate comments, or to that have been reclassified in accordance with the provisions of Amendinents, or to de roos and nortic Act (Act) that do not require approval of a premarket the Federal Pood, Drug, and Ocoments , therefore, market the device, subject to the general approval appreation (11.11). The general controls provisions of the Act include controls provisions of the Fiel. - 110 Jisting of devices, good manufacturing practice, requirements for aibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into controls. Existing major regulations affecting (PMA), it may be subject to such additions, Title 21, Parts 800 to 898. In your device can be found in the Sous nouncements concerning your device in the Federal Register.
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## Page 2 - Dr. Lietz
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 Incan that I DA has made a autes and regulations administered by other Federal agencies. Of the Act of ally i ederal bakes are requirements, including, but not limited to: registration 1 ou must comply with an art 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), abouting systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quality of other (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) This letter will anow Jourse of substantial equivalence of your device to a premarket nothloation. - The 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), If you desire specific at the for your at (240) 276-0115. 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 may volum 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/industry/support/index.html.
Sincerely yours,
Chiu-Li Lu, 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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## Indications for Use
510(k) Number K042965:
Device Name: TOMAS pin
Indications For Use: Temporary Orthodontic Micro Anchorage
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
N/A Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Kei Mulyton MSR
് സാനിലിന്റെയും General Hospitz. n Control, Dental Devices
Page 1 of 1
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.
