K051189 · Implant Innovations, Inc. · DZE · Jun 8, 2005 · Dental
Device Facts
Record ID
K051189
Device Name
PREVAIL DENTAL IMPLANTS
Applicant
Implant Innovations, Inc.
Product Code
DZE · Dental
Decision Date
Jun 8, 2005
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
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 restoration 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 mandible and splinted in the anterior region, immediate loading is indicated.
Device Story
PREVAIL dental implants are endosseous implants designed for surgical placement in the upper or lower jaw. They feature an internal and external hex connection and a lateralized seating surface. The device serves as a foundation for prosthetic attachments, including single tooth restorations, bridges, and overdentures. Used by dental surgeons in clinical settings, the implants provide mechanical stability for prosthetic components. The device is manufactured from Titanium Alloy (ASTM F-136) or Commercially Pure Titanium (ASTM F-67). By providing a secure anchor in the jawbone, the implants facilitate functional and aesthetic tooth replacement, with specific protocols for immediate loading in the anterior mandible when splinted.
Clinical Evidence
No clinical data provided; substantial equivalence is based on design and technological characteristics compared to predicate devices.
Technological Characteristics
Endosseous dental implants; materials: Titanium Alloy (ASTM F-136) or Commercially Pure Titanium (ASTM F-67); features internal and external hex connection with lateralized seating surface; available in lengths 8.5mm to 15.0mm; sterilization via ion beam irradiation.
Indications for Use
Indicated for patients requiring dental implants for prosthetic attachment in single tooth restoration, partially or fully edentulous spans, freestanding bridges, and overdenture retention. Immediate loading indicated for patients with ≥ 4 implants (≥ 10 mm 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.
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# JUN 8 - 2005
Implant Innovations, Inc. Implant Innovations, Inc.
Traditional 510(k) Premarket Notification – OSSEOTITE IOL Implant: Device Modification
## DEVICE NAME
1.0
| Device Trade Name | PREVAIL™ Implants |
|-----------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Classification Name | Dental Implants |
| ADDRESS AND REGISTRATION FOR MANUFACTURING AND<br>STERILIZATION SITES | |
| Sponsor | Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Tel.: 561-776-6700 |
| Official Correspondent | Jim Banic<br>Regulatory Affairs Specialist<br>Implant Innovations, Inc.<br>Tel.: 561-776-6932<br>Fax: 561-514 6316<br>Email: jbanic@3implant.com |
| Manufacturing Site | Implant Innovations, Inc.<br>4555 Riverside Drive<br>Palm Beach Gardens, FL 33410<br>Registration No. 1038806 |
| Sterilization Site | Ion Beam Applications (IBA)<br>formerly Sterigenics<br>1148 Porter Avenue<br>Haw River, NC 27258<br>Registration No. 1036836 |
#### CLASSIFICATION INFORMATION 2.0
| Device Class | Class II |
|----------------------|----------------------|
| Classification Panel | Dental Devices Panel |
| Regulation Number | 21 CFR §872.3640 |
| Product Code | DZE |
### LEGALLY MARKETED DEVICE INFORMATION 3.0
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The PREVAIL Implants are the subject of this 510(k) submission and are similar The I REVAL Implants are and cleared in the following premarket notifications:
- K031632 OSSEOTITE IOL Implants, cleared by letter dated September . 16, 2003.
- 10, 2009: . dated June 16, 2004.
- K935544 3i Implants, cleared by letter dated March 13, 1995. .
The proposed design modifications of the PREVAIL implants do not affect the intended use or alter the fundamental scientific technology of the device. Intended use of a Comparison Chart contained in Section F of this premarket notification.
#### INTENDED USE/INDICATION FOR USE 4.0
3i dental implants are intended for surgical placement in the upper or lower jaw to If delian infpants for prosthetic attachment in single tooth restoration and in provide a means for probablians 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 mandible and splinted in the anterior region, immediate loading is indicated.
The intended use of the PREVAIL implants is identical to those for the predicate devices cleared in K031632.
#### DEVICE DESCRIPTION 6.0
The PREVAIL implants are the same as the OSSEOTITE IOL implants [K031632] designed with an internal and external hex connection. The PREVAIL [XV21052] designed with and lateralized seating surface on both the miplants will nave the eralled implants. The PREVAIL implants will be manufactured from Titanium Alloy per ASTM F-136 or Commercially Pure Titanium per ASTM F-67.
The PREVAIL implants will be available in lengths of 8.5mm to 15.0mm with a The I REVAL implants will on. Reference is made to Section E for copies of engineering drawings. Catalog numbers are referenced in the following table.
Furthermore, the OSSEOTITE IOL implants [K031632] have been added to this submission, unmodified, in order to expand the indications.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wings, symbolizing health, human services, and well-being. The words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 8 - 2005
Mr. Jim Banic Regulatory Affairs Specialist Implant Innovations, Incorporated 4555 Riverside Drive Plam Beach Gardens, Florida 33410
Re: K051189
Trade/Device Name: Prevail Dental Implant Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: May 6, 2005 Received: May 10, 2005
Dear Mr. Banic:
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 Amendinone, or to arrived act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include controls providents of a 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 (1 Mr), it hay of cashes to the Code of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roundsh further announcements concerning your device in the Federal Register.
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### Page-2 Dr. Morgan
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that 1 DT 3 lobalites or weat your device complies with other requirements mean that IDA has made a decommanen ations administered by other Federal agencies. of the Act of ally I ederal statutes and registered. Including, but not limited to: registration You must comply with an the : loveling (21 CFR Part 801); good manufacturing practice alla listing (21 CFR Pat 607), labelity systems (QS) regulation (21 CFR Part 820); and if requirents as set form in the quarty sjoccare) ejections (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 you to begal mading of substantial equivalence of your device to a premarket notification: - The FDF Imalis 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 advice 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 outant other general miormational and Consumer Assistance at its toll-free Division of Dieself or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
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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Implant Innovations, Inc. Implant Innovations, Inc.
Traditional 510(k) Premarket Notification – OSSEOTITE IOL Implant: Device Modification
# Indications for Use
# 510(k) Number (if known):
Device Name:
### Indications for Use:
3i dental implants are intended for surgical placement in the upper or lower jaw to
r the surprises in the best and more in single tooth restoration and in partially 3i dental implants are intention in surgical procession and in partially or
provide a means for prosthetic attachment in single tooth resoration and to retain provide a means for prosthetic attachment in single took. Food.
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 In addition, when a minimum of 4 miplains; = 10 million and may = "
mandible and splinted in the anterior region, immediate loading is indicated.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sper Alvarez
Division of Anesthesiology, General Hospital. Infection Control, Dental Devices
510(k) Number:_
Page 1 of __
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.
