The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.
Device Story
Commercially pure titanium endosseous threaded implant; features external hex configuration for anti-rotation in single-tooth applications; apical flutes facilitate self-tapping installation. Used by dental surgeons for oral reconstruction; two-phase procedure: Phase I involves surgical placement in mandible/maxilla, followed by 3-4 month osteointegration period; Phase II involves abutment attachment and prosthetic restoration. Device provides mechanical interface for fixed/removable prosthodontic appliances; benefits patient through restoration of dental function and aesthetics.
Clinical Evidence
Bench testing only. Static mechanical testing performed on the INTERPORE Threaded Implant compared to existing mechanical data for the Branemark 3.75 mm Threaded Implant; results indicated the subject device was significantly stronger.
Technological Characteristics
Materials: Commercially pure titanium (ASTM F-67) and Ti-6AL-4V ELI alloy (ASTM F-136). Components: Implant cylinder, hex cover screw, healing abutments, impression copings, implant analogs, gold/plastic prosthetic components, paralleling pins, thread taps, and 17-4PH stainless steel (ASTM A-564) spade drills. Design: Endosseous threaded implant with external hex and apical cutting flutes. Sterilization: Not specified.
Indications for Use
Indicated for oral reconstruction in totally edentulous mandible/maxilla, large edentulous spans, bilateral/unilateral free-ends, and single tooth edentulous spaces. Contraindications: uncontrolled parafunctional habits, significant vascular impairment, metabolic bone disease, clotting disorders, current drug/radiation/steroid/anticoagulant therapy, uncontrolled diabetes, insufficient ridge dimensions, or active intraoral infection.
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
Nobelpharma Threaded Implants
Implant Innovations, Inc. (3i) Threaded Implants
Lifecore Threaded Implants
Reference Devices
Branemark 3.75 mm Threaded Implant
Submission Summary (Full Text)
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K960371
INTERPORE International
510(k) Premarket Notification
INTERPORE Self-Tapping Threaded Implant
Page 18
Exhibit 3
510(k) SUMMARY
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510(k) Premarket Notification
INTERPORE Self-Tapping Threaded Implant
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# 510(k) SUMMARY
## SUBMITTED BY
David P. Balding
Director, Regulatory Affairs and Quality Assurance
INTERPORE International
181 Technology Drive
Irvine, California 92718
(714) 453-3200
Date Submitted: January 25, 1996
## CLASSIFICATION, COMMON OR USUAL NAME, DEVICE NAME
Classification Name: Endosseous Implant
Common/Usual Name: Dental Implant
Proprietary Names: INTERPORE Threaded Implant (Wide Diameter)
## PREDICATE DEVICES
Nobelpharma Threaded Implants
Implant Innovations, Inc. (3i) Threaded Implants
Lifecore Threaded Implants
## DEVICE DESCRIPTION
The INTERPORE Self-Tapping Threaded Implant is a commercially pure titanium, machined, endosseous threaded implant with an external hex configuration on the top of the implant. The outer surface of the implant is externally threaded. The external threads originate at the inferior edge of the machined coronal collar of the implant and continue to the apical end of the implant. The apical end of the implant contains flutes which act as cutting edges to aid installation of the implant during the self-tapping procedure. The inner diameter of the implant is internally threaded with 2.5 mm threads designed for acceptance of a placement screw, a hex cover screw, a healing abutment, and a retaining screw. The latter device affixes the prosthetic appliance to the implant.
The incorporation of the external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications. It is designed to mechanically interface with a female hexagonal configuration on the mating prosthesis such that, when the retaining screw is tightened into place, the crown will not be allowed to rotate.
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510(k) Premarket Notification
INTERPORE Self-Tapping Threaded Implant
It also provides a wide variety of options with regard to the types of abutments that can be used for attachment of prostheses.
## INDICATIONS FOR USE
The INTERPORE Self-Tapping Threaded Implant is indicated for oral reconstruction in the totally edentulous mandible or maxilla, in large edentulous spans, for bilateral and unilateral free-ends and in restoration of single tooth edentulous spaces. It is designed to become an osteointegrated prosthesis allowing the attachment of removable and fixed partial or complete prosthodontic appliances. The external hexagonal projection is intended to provide an attachment system which minimizes crown rotation in single tooth applications.
## PRINCIPLES OF OPERATION
Oral reconstruction using the INTERPORE Self-Tapping Threaded Implant is a two phase procedure. In Phase I, the implant cylinder is surgically implanted in the residual ridge of the mandible or maxilla. Internally irrigated, precision drills are used to prepare the implant site. The INTERPORE Self-Tapping Threaded Implant is designed to be either self-tapped into place or the implant site may be pre-tapped using the Hand Bone Tap and Mount Driver or Ratchet Wrench. The implant is then properly seated, and the titanium Hex Cover Screw is affixed to seal the implant. Soft tissue is sutured into place to cover the implant and the implant is allowed to heal (osteointegrate) for approximately three to four months. During the healing period, the implant is not loaded, thus allowing the implant to heal in a stress-free environment.
After healing, Phase II procedures are initiated. The soft tissue over the implant is reopened, and the titanium Hex Cover Screw is removed. It is replaced with the Hex Healing Abutment, an abutment of appropriate height and diameter, which allows the gingiva to heal to the desired contour. Approximately two weeks later, the Hex Healing Abutment is removed and an impression of the top of the implant is made using an appropriate Hex Impression Coping which is mounted on the implant. Once the impression is made, the impression coping is removed and the Hex Healing Abutment is replaced onto the implant until the construction of the prosthodontic appliance has been completed by the dental laboratory. Final attachment of the prosthesis involves removing the Hex Healing Abutment, seating the prosthesis and tightening the titanium retaining screw.
## CONTRAINDICATIONS
Contraindications customary to oral surgery should be observed. These include, but are not limited to, uncontrolled parafunctional habits, significant vascular impairment to the implant site, metabolic bone disease, clotting disorders, current treatment with therapeutic agents which may have an effect on the surgical site, the surrounding tissue or normal biological healing responses (i.e., drug therapy, radiation therapy, chronic steroid treatment,
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INTERPORE Self-Tapping Threaded Implant
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anticoagulant therapy) and uncontrolled diabetes or other metabolic or systemic disorders which affect bone or wound healing.
The implant must not be used in patients where ridge dimensions are insufficient to accommodate proper implant placement.
Implants should not be used in patients who present with an active intraoral infection at the time of placement.
## COMPLICATIONS
The following complications have been reported in association with surgical procedures employing endosteal implants: failure to osteointegrate, loosening and loss of implant, soft tissue irritation due to insufficient width of attached gingiva, infection, early loss of implant due to inability to remove healing screw at reopening, implant loosening and fracture associated with coronal bone loss with apical retention.
## MATERIALS OF CONSTRUCTION
| Implant Cylinder | Commercially pure titanium conforming to ASTM F-67, Unalloyed Titanium for Surgical Implant Applications. |
| --- | --- |
| Hex Cover Screw | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. |
| Healing Abutments | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. |
| Impression Copings | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. |
| Implant Analogs | Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications. |
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Titanium Prosthetic Components
Commercially pure titanium conforming to ASTM F-67, Unalloyed Titanium for Surgical Implant Applications.
Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications.
Gold Prosthetic Components
Ceramicor, Everlast, or equivalent gold alloy with the following composition: 60% Gold, 20% Platinum, 20% Palladium
Castable Plastic Components
Delrin Resin #500, Manufactured by DuPont.
Paralleling Pin
Commercially pure titanium conforming to ASTM F-67, Unalloyed Titanium for Surgical Implant Applications.
Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications.
Thread Taps
Commercially pure titanium conforming to ASTM F-67, Unalloyed Titanium for Surgical Implant Applications.
Titanium alloy TI-6AL-4V ELI conforming to ASTM F-136, Wrought Titanium 6AL-4V ELI Alloy for Surgical Implant Applications.
Spade Drills
17-4PH Stainless Steel (UNS-S17400) conforming to ASTM A-564, Hot-Rolled and Cold-Finished Age-Hardening Stainless and Heat-Resisting Steel Bars and Shapes.
## COMPARISON OF TECHNOLOGICAL CHARACTERISTICS
The design, material, configurations, method of sterilization and other technological characteristics are similar to currently marketed predicate devices.
## NONCLINICAL TEST CONCLUSIONS
Static testing was performed on the INTERPORE Threaded Implant and compared with existing mechanical test data for the Branemark 3.75 mm Threaded Implant. Results showed that the INTERPORE Threaded Implant was significantly stronger than the Branemark implant.
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Learn the FDA Browser
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.
