Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the Abutment.
Device Story
Transmucosal abutments and screws for 3i endosseous dental implant system; used to connect dental implants to prosthetic restorations. Device acts as interface extending from surgically placed implant through soft tissue into oral cavity. Manufactured from Ti-13Nb-13Zr alloy; provides improved fatigue properties compared to commercially pure titanium. Used by dental surgeons in clinical settings. Output is physical support structure for dental prostheses. Benefits include restoration of dental function via osseointegrated connection.
Clinical Evidence
Bench testing only. Physical testing indicates improved fatigue properties for the Ti-13Nb-13Zr alloy compared to commercially pure titanium. No clinical data provided.
Technological Characteristics
Material: Ti-13Nb-13Zr alloy. Form factor: Various transmucosal abutment styles (standard, conical, tapered, emergence profile, etc.). Sterilization: Co60 Irradiation (min 25.0 kGy) to achieve SAL 10^-6, validated per AAMI guidelines and EN 552.
Indications for Use
Indicated for patients requiring dental implant surgery to replace missing teeth. Contraindicated in patients with insufficient jaw bone width or height to support the implant.
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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3i
K962465
3071 Continental Drive
West Palm Beach, FL 33407
1-800-443-8166 (407) 840-2600
FAX (407) 840-2660
IMPLANT INNOVATIONS
# SEP 20 1996
# SIOCK) Summary
510(k) SUBMISSION: MATERIAL CHANGE (ADDITION) - TITANIUM 13-NIOBIUM 13-ZIRCONIUM (Ti-13Nb-13Zr) FOR TRANSMUCOSAL ABUTMENTS FOR THE 3i ENDOSSEOUS DENTAL IMPLANT SYSTEM.
1. CLASSIFICATION NAME: Endosseous Dental Implants
2. COMMON/USUAL NAMES: Transmucosal Abutments and Screws, Transmucosal Elements, Abutment Cylinders and Screws, Abutments, Conical, Standard, Temporary, Tapered, etc.
3. PROPRIETARY NAME: Standard Abutments and Screws, Conical Abutments and Screws, Emergence Profile Abutments and screws, Tapered Abutments, Temporary Healing Screws and Abutments, Posts and Cylinders, Non-Rotating Abutments, Abutment Posts, STR (Single Tooth Restoration) Abutments, "O-Ring" and "Dal-Ro" Abutments.
4. CLASSIFICATION: Transmucosal Abutments are not in and by themselves classified. They are however, considered an integral part of the implant and are therefore classified as the implant. Endosseous dental implants, per 872.3640 have been classified as class III devices. PMA's may be required for some or all designs of endosseous dental implants including abutments, but no effective date has been established for the PMA submission.
5. PERFORMANCE STANDARDS: Not applicable at this time.
6. FORM: 3i's various abutment systems have historically been constructed of CP Titanium per ASTM specifications. This material change covers all styles and sizes of transmucosal abutments as listed herein, and pertains exclusively to a new alloy, that will be used in the production of the abutment components; from CP Titanium, to a Titanium, Niobium, Zirconium (Ti-13Nb-13Zr).
Abutment systems include:
| Standard Abutments | Tapered Abutments |
| --- | --- |
| Emergence Profile Abutments | Temporary Healing Abutments |
| Conical Abutments | Abutment Posts |
| Pre-Angled Abutments | Overdenture Abutments |
| Temporary Screws | Temporary Cylinders |
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## 6a. NEW MATERIAL - Ti1313:
Ti1313 is a titanium alloy consisting of Titanium, Niobium and Zirconium. Extensive physical and biological testing of the Alloy has been performed and the material is currently used in orthopedic applications. It recently received distribution clearance through the Pre-Market Notification process for 3i's Endosseous Dental Implants.
Physical testing by both the developer of Ti1313 and Implant Innovations, Inc. indicates an improvement in fatigue properties over commercially pure titanium which has previously been used in the construction of the transmucosal abutment and retaining screw systems.
For Abutment Systems included in this submission, there is no change in manufacturing or processing operations from those employed using the original titanium material.
Sterilization (where indicated) shall be accomplished using Co60 Irradiation, at a minimum dose of 25.0 kGy (2.5 mRads), achieving a Sterility Assurance Level (SAL) of 10(-6). Validation of sterilization process is accomplished as specified by the AAMI (Association for the Advancement of Medical Instrumentation) Guidelines and the Harmonized European Standard EN 552.
Irradiation sterilization is accomplished by an FDA registered irradiation sterilization facility.
## 7. LABEL/LABELING MATERIALS:
The proposed material change will not necessitate revisions to device labeling or instruction sheets, other than catalog number and description, stating the new material.
## 8. SUBSTANTIAL EQUIVALENCE:
The material change has not alter the previously obtained substantial equivalence determination, for the various abutment systems. This is based on the fact that there has been no change in component design, other than the proposed change to Ti1313, and there are no other changes in manufacturing or processing. 3i is making no claims relative to these changes at this time, and indications for use of the various abutment systems have not changed.
## 9. INDICATION FOR USE:
Abutments are designed for use in dental implant surgery. The 3i system includes a variety of types and sizes of specially designed bone-implantable titanium and titanium alloy implants and abutments. The implants are surgically inserted into upper and/or lower jawbones and upon
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healing an abutment may be placed on the implant, extending the implant's coronal aspect through the soft tissues and into the oral cavity. A prostheses is then attached to the Abutment.
A successfully osseointegrated implant will achieve a firm and direct connection between the living bone and the surface of the titanium or titanium alloy implant when surgically implanted under controlled conditions, per well known clinical studies.
## 11. CONTRAINDICATIONS:
3i implants and Abutments should not be used in cases where the remaining jaw bone is too diminished to provide adequate width or height to surround the implant. Lack of osseointegration or subsequent implant failure may occur in cases where there is insufficient available bone or poor bone quality.
## 12. WARNINGS:
For safe and effective use of 3i implants and abutments, it is strongly suggested that specialized training be undertaken since the surgical techniques required to place dental implants are highly specialized and complex procedures. Improper patient selection and technique can cause implant and/or abutment failure with possible loss of supporting bone.
## 13. PRECAUTIONS:
Thorough screening of prospective implant candidates must be performed. Visual inspection as well as panoramic and periapical radiographs are essential to determine anatomical landmarks, occlusal conditions, periodontal status, and adequacy of bone. Lateral cephalometric radiographs, CT Scans, and tomograms may also be beneficial.
## 14. ADVERSE EFFECTS:
Loss of implant anchorage (failure to osseointegrate) and loss of the prosthesis are possible occurrences after surgery. Lack of quantity or quality of remaining bone, infections, poor patient oral hygiene or cooperation, and generalized diseases (diabetes, etc.) are some potential causes for loss of anchorage.
## 15. SURGICAL COMPLICATIONS:
The implant procedure has risks, including localized swelling, dehiscence, tenderness of short duration, edema, hematoma, or bleeding.
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Numbness of the lower lip and chin region following lower jaw surgery, and of the tissue beside the nose following upper jaw surgery, is a possible side effect of the surgery. Though it would most probably be of a temporary nature, in very rare cases, the numbness has been permanent.
Gingival/Mucosal (gum tissue) ulceration, tissue reaction, or infection may occur, but generally responds to local care.
## 16. PRE-MARKET NOTIFICATION CERTIFICATION AND SUMMARY FOR SUBMISSION:
I certify that I have conducted a reasonable search of all information known or otherwise available to me about the types and causes of safety and/or effectiveness problems that have been reported for Endosseous Dental Implant systems.
Failure to osseointegrate or loss of osseointegration can be caused by improper patient selection (patients with systemic diseases which affect bone physiology, patients with habits such as bruxing or clenching, patients who are physically or psychologically unable to carry out proper implant hygiene, heavy smoking or alcohol use), by improper surgical technique (overheating of bone) or improper case planning or restorative technique (overloading of implants through improper placement, use of an insufficient number of implants or excessive cantilever). Improper implant processing by the manufacturer or improper handling by the customer, resulting in contamination, can also effect osseointegration.
Fracture of implants can occur, particularly in implants with apical cross-holes. Fracture occurs either on insertion of screw-type implants due to excessive torque (improper surgical technique such as an error in drill selection) or in service due to loss of bone.
Fracture of abutments and abutment screws occurs in implant systems and is usually attributed to factors within the control of the implant team, such as lack of passive fit of the restoration or excessive cantilever, or within the control of the patient, such as bruxing.
Other types of safety and efficacy problems which have been observed for endosseous dental implant systems are local soft tissue degeneration and bone resorption, paresthesia, perforation of the maxillary sinus, perforation of labial and lingual plates, local and systemic infection, prosthetic framework fracture, nerve injury, bone fracture, injury to adjacent teeth and their
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supporting bone, oroantral or oronasal fistula, gingival hyperplasia, soft tissue overgrowth, perforation of the gingiva by the healing screw, mucosal abscess, displacement of the implant into the mandibular canal, hemorrhage of the floor of the mouth due to transection of the sublingual artery and breakage of drill tip, requiring surgical removal.
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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.
