The BioHorizons Maximus 3.0mm implant may be used: (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion. (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function. (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function. The BioHorizons Maximus OS implant may be used for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
Device Story
Maximus 3.0mm and OS implants are machined titanium screw-form dental implants; used as artificial root structures for tooth replacement or denture stabilization. Implants are surgically placed into the jawbone by dental professionals. Surface treated with Hydroxylapatite (HA) to promote fixation. Available in various lengths and collar heights. Provides stable foundation for prosthetic restoration; allows for immediate function in specific clinical scenarios. Benefits include improved denture stability and tooth replacement functionality.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Machined titanium alloy (ASTM F 136, UNS R56401). Screw-form geometry. Surface treated with Hydroxylapatite (HA) coating. Sterilized via radiation (ANSI/AAMI/ISO 11137) to a minimum sterility assurance level of 10^-8.
Indications for Use
Indicated for single tooth replacement of mandibular central/lateral incisors and maxillary lateral incisors; multiple tooth replacement of mandibular incisors (when splinted); and denture stabilization in the anterior mandible and maxilla.
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.
BioHorizons the Maestro System 3.0mm diameter implant (K032351)
BioHorizons Maximus OS (Overdenture System) Implant (K041938)
Submission Summary (Full Text)
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SEP 2 0 2005 મ BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
K052419
## 510(k) Summary 21 CFR 807.92
Date: Official Contact: Manufacturer:
August 26, 2005 Winston Greer, Vice-President, QA & RA BioHorizons Implant Systems, Inc. One Perimeter Park South Suite 230 South Birmingham, AL 35243 Phone: (205) 967-7880 Fax: (205) 870-0304
### Proprietary Name
The Maximus™ 3.0mm and OS Implants
## Common Name
Screw-type Dental Implant
### Classification Name
Endosseous implants, surgical components, and prosthetic attachments
# Predicate Devices
Predicate devices are:
- 1. The BioHorizons Dental Implant System, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K960026, concurrence date March 28, 1996.
- 2. BioHorizons the Maestro System™ 3.0mm diameter implant, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K032351, concurrence date October 21, 2003.
- 3. BioHorizons Maximus OS (Overdenture System) Implant, a screw-type endosseous implant manufactured and distributed by BioHorizons Implant Systems, Inc. Authorization to legally market the predicate implant device has been documented under 510(k) number K041938, concurrence date July 22, 2004.
### Device Description
The BioHorizons Maximus 3.0mm and OS implants are machined titanium, screw-form implants supplied in lengths of 12mm, 15mm and the Maximus OS implant is further supplied with tissue collar heights of 2mm and 4mm, available with each length. Implant raw material is titanium alloy as specified in ASTM F 136, Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
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BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
> The device is further processed by treating the surface with Hydroxylapatite (HA) media to promote implant fixation. The product is packaged using materials known in the to promote impropriate for medical device packaging and is provided with a minimum sterility assurance level of 10-8, validated in compliance to ANSI/AAMI/ISO 11137, Sterilization of healthcare products - Requirements for validation and routine control -Radiation Sterilization.
> The Maximus 3.0mm and OS implants are comprehensive systems containing implants and surgical components. The Maximus 3.0mm diameter implant may be used (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors, with or without tissue reflection; (2) when splinted indeers an an artificial root structure for multiple tooth replacement of mandibular incisors; and, (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. In single cases they may be placed in immediate function out of occlusion with a temporary prosthesis. The Maximus OS implant is a system with the implants configured specifically for use in denture stabilization; reference the Intended Use section following.
All BioHorizons implants referenced in this submission are 3.0mm in diameter with surface treatment using Hydroxylapatite coating. The following table provides a summary of the proposed catalog item or reference numbers by implant length and collar height.
| Length<br>(mm) | Catalog<br>REF Number | |
|----------------|-----------------------|--------------------|
| | Maximus 3.0mm implant | Maximus OS implant |
| 12 | 3012D4 | 3012OS2H |
| 12 | | 3012OS4H |
| 15 | 3015D4 | 3015OS2H |
| 15 | | 3015OS4H |
| 18 | 3018D4 | 3018OS2H |
| 18 | | 3018OS4H |
### Intended Use
で
The BioHorizons Maximus 3.0mm implant may be used:
- (1) as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors. The implant may be immediately restored with a temporary prosthesis that is not in functional occlusion.
- (2) when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors. The implants may be restored after a period of time or placed in immediate function.
- (3) for denture stabilization using multiple implants in the anterior mandible and maxilla. The implants may be restored after a period of time or placed in immediate function.
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BioHorizons Implant Systems, Inc. HA-Coating Maximus™ 3.0 & OS Special 510(k): Device Modification August 26, 2005
> The BioHorizons Maximus OS implant may be used for denture stabilization using The Diononzons Maximus OO Implant may oo as as a subla. The implants may be restored after a period of time or placed in immediate function.
# Technological Characteristics
ollulcal Sharacteristics
The fundamental scientific technology of the device is identical to the referenced in The fundatherital solements, suppliers, processing, packaging and sterilization predicate devices. An materials, cappilere, procession prosecures Maximus 3.0mm and OS methods remain the Same do for the productions 3.0 and OS implants are substantially implant to all features of the predicate devices which could affect safety or equivalorit to an roaterse of the pilarities in design, material and intended use.
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Image /page/3/Picture/1 description: The image is a black and white circular logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized human figure with three flowing lines extending from the figure's head, resembling a bird in flight.
SEP 2 0 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Winston Greer Vice-President, QA & RA BioHorizons Implant Systems, Incorporated One Perimeter Park South, Suite 230 Birmingham, Alabama 35243
Re: K052419
K032417
Trade/Device Name: BioHorizons Maximus 3.0mm and OS Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: August 26, 2005 Received: September 2, 2005
Dear Mr. Greer:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your because on (4) + = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = referenced adove and have determined and as neally marketed predicate devices marketed in indications for use stated in the chelosary to eag.
interstate commerce prior to May 28, 1976, the enactment date of the Medical Device interstate commerce prior to way 20, 1778, the children with the provisions of Amendments, of to devices mat nave obcit (Act) that do not require approval of a premarket the Federal Food, Drug, and Cosmette 100 (10) -------------------------------------------------------------------------------------------------------------------------------approval application (1 Mrx). Four 110), Pour Styles provisions of the Act include controls provisions of the Fiel. The gasting of devices, good manufacturing practice, requiremonts for anitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (soc above) into enontrols. Existing major regulations affecting (PMA), it may be subject to submitter. Forel Regulations, Title 21, Parts 800 to 898. In the Architector I your device can be found in the South 11.
addition, FDA may publish further announcements concerning your device in the Federal Register.
{4}------------------------------------------------
#### Page 2 - Mr. Greer
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be advised that FDA s Issuance of a subscribes with other requirements
mean that FDA has made a determination that your devices with other Federal agencies mean that FDA has made a decembination and your and your and miter Federal agencies.
of the Act or any Federal statutes and regulations absortunited to: registration of the Act or any Federal statues and reginations, but not limited to: registration
You must comply with all the Act step of a condiness and menufacturing practice You must comply with an the Act 3 requirences, introducing, cool manufacturing practice.
and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practic and listing (21 CFR Part 807), labelling (21 cm Party are (21 CFR Part 820); and if
requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); of the requirements as set forth in the quality systems (QD) regulation (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)
the success of the support of a line of select stick aggivelence of way device This letter will allow you to begill maticemig your atial equivalence of your device to a
premarket notification. The FDA finding of substantial equivalers and thus, ne premarket notification. The PDA intellig of Sabbanials of Any Survey 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 for your device on our accoming of garden one the regulation please contact the Office of Compilance at (210) 270-578 Part 807.97). You
entitled, "Misbranding by reference to premarket notification wades the Act from the entifled, "Misbranding by lefelect to premation on your responsibilities under the Act from the may obtain other general information on your copy cossumer Assistance at its toll-free
Division of Small Manufacturers, International and Consumer Assistance at its toll-free Division of Sinan Manufacturers, 143-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Clus
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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BioHorizons Implant Systems, Inc. Blor onzons Implant Systems, ................................................................................................................................................. August 26, 2005
Page 1 of 1
510(k) Number: K052419
Device Name: BioHorizons Maximus 3.0mm and OS Implants
Indications for Use:
The BioHorizons Maximus 3.0 Implants may be used (1) as a nrtificial root structure for The BloHofizons Maximus 5.0 Implants may bo assort and maxillary lateral
single tooth replacement of mandibular central and laith tomperary prosthesis that is single tooth replacement of mandibular ocurated with a temporary prosthesis that is
incisors. The implant may be immediately restored with a temporary prosthesis for includio. The implair may be inimodiating rogether as an artificial root structure for not in functional occusion, (2) when Spiritoritors. The implants may be restored after a
multiple tooth replacement of mandibular incisors. The implants may multiple multiple tooln replacement of manabolial the stablization using multiple
period of time or placed in immediate function; (3) for dentures ater a period of time of placed in inimodiate fansila. The implants may be restored after a period of time or placed in immediate function.
The BioHorizons Maximus OS Implants may be used for denture stabilization using The Blorionzons Maximus OO Implants may be restored after a period of time or placed in immediate function.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susun Russe
ിഴിടിon Sign-Off
Division of Anesthesiology, General Hospital, Infection Control, Dental Devi
510(k) Number. T152419
Prescription Use
(per 21 CFR 801.109)
OR
Over-the-Counter Use
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.
