K963224 · Steri-Oss, Inc. · DZE · Nov 14, 1996 · Dental
Device Facts
Record ID
K963224
Device Name
STERI-OSS IMPLANTS FOR SINGLE STAGE PLACEMENT
Applicant
Steri-Oss, Inc.
Product Code
DZE · Dental
Decision Date
Nov 14, 1996
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.
Device Story
Endosseous dental implants serve as artificial roots to support prosthetic devices (crowns/bridges) for restoring chewing function. Implants are surgically placed into the jaw bone using a single-stage surgical placement method. The device provides a stable foundation for abutments and subsequent prosthetic restoration. Used in dental clinics by dentists. Benefits include restoration of masticatory function for patients with missing teeth.
Clinical Evidence
No clinical data provided; substantial equivalence is based on identical technological characteristics to previously cleared devices.
Technological Characteristics
Materials: Titanium alloy, hydroxyapatite (HA) coating, or titanium plasma spray (TPS) coating. Configurations: Threaded or cylindrical, flat top or hex lock. Dimensions: 3.25-5.0 mm diameter, 8-18 mm length. Sterilization: Sterile. Energy source: None (mechanical).
Indications for Use
Indicated for patients who have lost natural dentition due to disease, trauma, or other causes, requiring restoration of chewing function via endosseous dental implants.
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
Steri-Oss Titanium Alloy Screw Series Implant For Single Stage Surgical Placement (SSP) (K944158)
Submission Summary (Full Text)
{0}
K903224
Steri-Oss Implants For Single Stage Placement 510(k)/SSP
SECTION 7: 510(k) SUMMARY
NOV 14 1996
## Letterhead
510(k) Summary
## Manufacturer Information:
Submitter's Name: Steri-Oss Inc.
Address: 22895 Eastpark Drive Yorba Linda CA 92887, U.S.A.
Contact's Name: Jeff Hausheer, Ph.D. Regulatory Affairs
Telephone Number: 714-282-4800, extension 3815
Date Prepared: August 1996
## Device Names:
Common Name: Endosseous Dental Implant for Single Stage Surgical Placement
Trade Names: See appended list (page 4)
Classification Name: Endosseous Implant (all designs)
## Predicate Device:
Substantial equivalence is claimed to
Steri-Oss' Oss' "Titanium Alloy Screw Series Implant For Single Stage Surgical Placement ("SSP")". an uncoated 3.8-mm diameter threaded titanium alloy implant (510(k) number K944158, Steri-Oss catalog numbers 2208, 2210, 2212, 2214, 2216, and 2218).
## Device Description:
1) How The Device Functions:
Steri-Oss Single Stage Surgical Placement dental implants are designed to serve as supports for prosthetic devices intended to restore a patient's chewing function.
August 1996
{1}
SECTION 7: 510(k) SUMMARY (continued)
## Device Description (continued):
### 2) Scientific Principles:
Natural teeth are anatomically composed of a root - the subgingival portion of the tooth - and a crown - that part of the tooth above the gum. Dental implants are intended to mimic the root portion of this structure to aid in restoration of chewing function in patients who have lost natural dentition through disease, trauma or other cause. Implants integrate into the jaw bone. By providing a stable foundation analogous to the root portion of a natural tooth, and in combination with an abutment structure (i.e., a foundation for an artificial crown), dental implants provide a platform upon which the dentist can build an artificial crown or bridge, thereby restoring the patient's ability to chew.
### 3) Physical Characteristics
The Steri-Oss Single Stage Surgical Placement implants are slightly tapered and vary in diameter from 3.25 millimeters to 5.0 millimeters (neck dimension) depending upon the specific implant design, and vary from 8 millimeters to 18 millimeters in length. They may have no coating or a coating consisting of titanium alloy or hydroxyapatite. Titanium or hydroxyapatite coatings are applied as a plasma spray. The implants are available in cylindrical or threaded configurations and have either a flat top or a hex lock configuration at the apical surface.
## Intended Use:
Steri-Oss Single Stage Surgical Placement implants are intended to serve as support for prosthetic devices to restore patient chewing function and are surgically placed using the single stage surgical placement method.
## Comparison to the Predicate Device(s):
Steri-Oss implants indicated for single stage surgical placement are identical in all aspects to corresponding implants cleared for marketing for placement using the two stage surgical placement method, including the materials from which they are fabricated, the fabrication methods, the physical dimensions and geometry, the method of sterilization, the type of packaging, and all other respects.
38
{2}
# SECTION 7: 510(k) SUMMARY (continued)
The following table provides a comparison of the technological characteristics of the Steri-Oss implant and the predicate device
Product Comparison
| Characteristic | Predicate Device | Submission Device |
| --- | --- | --- |
| Body Material | Titanium alloy | Same |
| Coating Materials | None, or
HA or
TPS
(depending upon configuration) | Same |
| Design | Threaded or cylindrical | Same |
| Superior surface | Flat or Hex Lock | Same |
| Length (mm) | 8, 10, 12, 14, 16, 18 mm | Same |
| Diameter (mm) | 3.25, 3.8, 4.1/4.5, 5.0/4.5 mm | Same |
| Packaging | Double vial | Same |
| Sterility | Sterile | Same |
Page 3 of 4
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Page 4 of 4
10
# SECTION 7: 510(k) SUMMARY (continued)
## Trade Names:
1) Flat-top, threaded, HA-coated, 3.8-mm diameter SSP
2) Flat-top, cylinder, HA-coated, 3.25-mm diameter SSP
3) Flat-top, cylinder, HA-coated, 3.8-mm diameter SSP
4) Flat-top, cylinder, TPS-coated, 3.25-mm diameter SSP
5) Flat-top, cylinder, TPS-coated, 3.8-mm diameter SSP
6) Hex-lock, threaded, uncoated, 3.25-mm diameter SSP
7) Hex-lock, threaded, uncoated, 3.8-mm diameter SSP
8) Hex-lock, threaded, uncoated, 4.1-mm neck / 4.5-mm body diameter SSP
9) Hex-lock, threaded, uncoated, 5.0-mm neck / 4.5-mm body diameter SSP
10) Hex-lock, threaded, HA-coated, 3.25-mm diameter SSP
11) Hex-lock, threaded, HA-coated, 3.8-mm diameter SSP
12) Hex-lock, threaded, HA-coated, 4.1-mm neck / 4.5-mm body diameter SSP
13) Hex-lock, threaded, HA-coated, 5.0-mm neck / 4.5-mm body diameter SSP
14) Hex-lock, threaded, TPS coated, 3.25-mm diameter SSP
15) Hex-lock, threaded, TPS coated, 3.8-mm diameter SSP
16) Hex-lock, threaded, TPS coated, 5.0-mm neck/4.5-mm body diameter SSP
17) Hex-lock, cylinder, HA-coated, 3.25-mm diameter SSP
18) Hex-lock, cylinder, HA-coated, 3.8-mm diameter SSP
19) Hex-lock, cylinder, TPS coated, 3.25-mm diameter SSP
20) Hex-lock, cylinder, TPS coated, 3.8-mm diameter SSP
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.
