3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.
Device Story
3i Dental Implants are endosseous implants used for prosthetic attachment in the jaw. This submission expands indications to include immediate occlusal loading in the mandible when using at least four splinted implants (≥10mm). The system includes standard abutments and a new single-piece abutment combining screw and abutment. Clinicians perform surgical placement and prosthetic loading. The device provides a stable foundation for dental restorations, benefiting patients by allowing immediate function in specific mandibular cases. Mechanical performance is verified through static compression and cyclic fatigue testing.
Clinical Evidence
Clinical evidence consists of literature reviews and case reports. Studies (e.g., Tarnow et al., Testori et al., Defrancq et al., Ibanez and Jalbout) demonstrate successful osseointegration and clinical outcomes for immediate loading of dental implants in edentulous and partially edentulous patients. Histomorphometric evaluation showed 78%-85% bone-to-implant contact. Success rates reported in literature support the safety and efficacy of the immediate loading indication.
Technological Characteristics
Endosseous dental implants and abutments. Materials are identical to existing 3i systems. Includes standard and new single-piece abutments. Mechanical testing performed per FDA guidance for screw-type endosseous implants. Testing included static load compression, cyclic fatigue, and insertion torque (passed at >5x recommended 20 Ncm).
Indications for Use
Indicated for patients requiring prosthetic attachment in single tooth restorations, partially or fully edentulous spans, freestanding bridges, or overdentures. Immediate loading is indicated for patients with at least 4 implants (≥10mm length) placed and splinted in the anterior mandible.
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.
{0}------------------------------------------------
# K030614
# SEP 1 5 2003
## 510(k) Summary
| 510(k)<br>Summary | This summary of 510(k) safety and effectiveness information is being<br>submitted in accordance with the requirements of 21 C.F.R. § 807.92. |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter | Implant Innovations, Inc. (3i) |
| Contact<br>Person | Mrs. Jacquelyn A. Hughes, RAC<br>Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>(561) 776-6819<br>jhughes@3implant.com |
| Date Prepared | June 19, 2003 |
| Device Name | 3i Dental Implants |
| Classification<br>Names | Endosseous dental implant |
| Device<br>Classification | Classification: III<br>Classification Panels: Dental<br>Regulation Number: 872.3640 |
| Predicate<br>Device(s) | 3i Dental Implants<br>(K860653, K874590, K935544,K950204, K955428, K972444, K983347,<br>K014235, K022009)<br>3i Abutments/Accessories<br>K871863, K871954, K891613, K895462, K895463, K904228, K934126,<br>K933969, K933462, K932123, K951553, K022113<br>Nobel Biocare Branemark System Implants (K992937, K022562)<br>FRIADENT FRIALIT-2 Implant (K994376)<br>Straussman ITI Implant (K984104)<br>Dentatus MTI Modular Transitional Implants (K980620) |
| Performance<br>Standards | Performance standards have not been established by the FDA under section<br>514 of the Federal, Food, Drug and Cosmetic Act. |
:
{1}------------------------------------------------
| Device<br>Description | This 510(k) requests an expansion of the indications for use of all externally<br>and internally hexed 3i dental implants to include immediate loading<br>procedures in the mandible when using a minimum of four (4) splinted<br>implants $≥$ 10mm in length. Standard, commercially available 3i abutments<br>and screws can be used with 3i dental implants in immediate loading<br>procedures. Several new components will complement the standard line for<br>the clinicians use as necessary in immediate occlusal loading. |
|---------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | 3i dental implants are intended for surgical placement in the upper or lower<br>jaw to provide a means for prosthetic attachment in single tooth restorations<br>and in partially or fully edentulous spans with multiple single teeth,<br>freestanding bridges and to retain overdentures. |
| | In addition, when a minimum of 4 implants, $≥$ 10 mm in length, are placed in<br>the mandible and splinted in the anterior region, immediate loading is<br>indicated. |
| Technological<br>Characteristics | The proposed 3i implants and accessories are identical to the currently<br>marketed 3i dental implants and accessories and similar in design, materials,<br>and intended use to other legally marketed dental implant systems that are<br>indicated for immediate loading. In addition to the standard 3i abutments, 3i<br>proposes to add a single piece abutment which combines the abutment and<br>screw into a single piece for ease of use. |
| Nonclinical<br>Performance<br>Testing | 3i implants have been mechanically tested consistent with the FDA guidance<br>document Information Necessary for Premarket Notifications Submissions for<br>Screw-Type Endosseous Implants (December 9, 1996). Static Load<br>compression testing was used to simulate biting forces placed upon the<br>implants and Cyclic Fatigue testing simulated the chewing forces placed upon<br>the implants. The new single piece abutment was tested for insertion torque<br>and passed at more than five times the recommended insertion torque of 20<br>Ncm. The single piece abutment was also tested and passed Cyclic Fatigue<br>criteria. Animal studies which proved early loading to be successful for 3i's<br>OSSEOTITE implant systems were submitted in K983347 (cleared September<br>23, 1998). Subsequent data continues to provide evidence of substantial<br>clinical success with early loading. Current practice in the field includes use<br>in a manner described within this 510(k) with clinicians and laboratories<br>working to achieve immediate occlusal loading in edentulous and partially<br>edentulous patients with Types I, II and III bone. |
| Clinical<br>Performance<br>Testing | A current review of the literature suggests clinical success using immediate<br>loading with fully and partially edentulous patients with OSSEOTITE, TPS,<br>Ha-coated, and grit-blasted surfaces when the occlusal load is well-distributed.<br>A few are summarized here and a bibliography may be found in Appendix 3 |
:
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------
:
. "
{2}------------------------------------------------
of the submission.
Tarnow DP,Emtiaz S, Classi A. Immediate loading of threaded implants at stage 1 surgery in edentulous arches: Ten consecutive case reports with 1 to 5 year data.Int. J. Oral Maxillofac Implants 1997; 12:319-324. Tarnow et al report on ten consecutive, edentulous cases comparing the use of implants manufactured by Nobel Biocare (cases 1-3 and 5-7), ITI Straumann (case 4), Astra Tech (cases 8 and 9)and 3i Implant Innovations (case 10). Of 107 implants placed, 104 osseointegrated. For medicolegal reasons, 38 of the implants were submerged and unloaded. The three failed implants occurred in cases 2 and 3, one submerged due to an infection from an adjacent extraction site and two loaded implants due to the cemented provisional restoration being tapped off at 4 months.
Testori T, Szmukler-Moncler s,Francetti L,Del Fabbro M, Scarano A, Piattelli A, Weinstein R Immediate loading of Osseotite implants: A case report and histologic analysis after 4 months of occlusal loading. Int. J. Periodontics Restorative Dent. 2001;21,5:451-459. Testori et al studied 12 Osseotite implants in the mandible of one patient of which 6 were bilaterally splinted and immediately loaded and 6 were left to heal in a submerged manner. Clinical and histologic osseointegration was confirmed for two of the immediately loaded implants by retrieval after 4 months of function. Histomorphometric evaluation revealed 78%-85% bone-to-implant contact, indicating osteogenesis and bone remodeling were not impeded by immediate loading.
Defrancq WD,Luc MDT,Rutten P. Immediate loading: Immediate loading of implants - clinical and technical procedure. Dental Dialogue 2002;2:246-275. Defrancq et al report successful use of an immediate loading technique in 102 procedures for both maxilla and mandible. Of 417 Osseotite implants in 68 mandible procedures only 2 were lost and only 9 of 309 Osseotite implants were lost in 34 maxilla procedures. In ten patients, implants were inserted in both the mandible and maxilla in the surgery for immediate loading.
Ibanez, JC, Jalbout,ZN. Immediate loading of Osseotite implants: Two-year results. Implant Dentristry 2002;11,2:128-134. Ibanez and Jalbout report 100% success in the use of 87 Osseotite implants for immediate loading in eleven patients after two-three years follow-up. Follow-up consisted of both clinical and radiographic examination which found no implant mobility or periimplant radiolucency.
Clincal reports are included in Appendix 3 for reference by Chiapasco et al, Jaffin et al, Schnitman et al, Szmukler-Moncler et al, and Balshi and Wolfinger which discuss the use of immediate loading with various competitive implants to which 32 implants are substantially equivalent in design and materials.
{3}------------------------------------------------
#### The 3i dental implants and accessories are substantially equivalent to the Conclusion legally marketed 3i dental implant systems, Branemark System (Nobel Biocare), FRIALIT-2, Straumann ITI and Dentatus dental implant systems.
{4}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/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" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
SEP 1 5 2003
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Jacquelyn A. Hughes Director, Regulatory Affairs & Quality Assurance Implant Innovations, Incorporated 4555 Riverside Drive Palm Beach Gardens, Florida 33410
Re: K030614
Trade/Device Name: 31 Dental Implants Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: III Product Code: DZE Dated: June 19, 2003 Received: June 20, 2003
Dear Ms. Hughes:
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.
{5}------------------------------------------------
Page 2 - Ms. Hughes
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 (QS) 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.
Susan Runner
Susan Runner, DDS, MA Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{6}------------------------------------------------
## Indications for Use Statement
Page 1 of 1
510(k) Number (if known): K030614 Device Name: 3i Dental Implants
Indications for Use:
3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth, freestanding bridges and to retain overdentures.
In addition, when a minimum of 4 implants, ≥ 10 mm in length, are placed in the the mandible and splinted in the anterior region, immediate loading is indicated.
Rein Muly for MSR
Division of Anesthesiolo Infection Control, Denta
510(k) Number.
### (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
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.
