Lifecore Biomedical Dental Implants are intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.
Device Story
System comprises two-stage, root-form tapered and straight-walled threaded dental implants with internal connection anti-rotational feature; includes surgical/restorative instrumentation (drills, taps, depth gauges, drivers). Implants feature Resorbable Blast Media (RBM) roughened surface. Used by clinicians in dental procedures for tooth replacement. Implants placed into mandible or maxilla; restored with temporary or permanent prostheses. Benefits include restoration of dental function and aesthetics for edentulous patients.
Indicated for partially or fully edentulous patients requiring single or multiple-unit dental restorations (cement-retained, screw-retained, or overdenture) or fixed bridgework support. Includes immediate placement into extraction sockets and immediate provisionalization (with or without occlusal contact) in good quality bone.
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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Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System
K05/614
SEP - 9 2005
## 510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]
#### 1. Submitter's Name and Contact Person
| Lifecore Biomedical, Inc. | Rachel Kennedy |
|---------------------------|-------------------------------------|
| 3515 Lyman Blvd | Regulatory Affairs Manager |
| Chaska, MN 55318 | Ph: 952-368-6294; Fax: 952-368-4278 |
#### 2. General Information
| Trade Name | Lifecore PrimaConnex™ Internal<br>Connection Implant System |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant system |
| Classification Name | Endosseous implant |
| Identification of Predicate Devices | Restore® Self-Tapping Dental<br>Implant System, RD (Lifecore<br>Biomedical, Inc.) (K924589) Restore® Self-Tapping Dental<br>Implant System, WD (Lifecore<br>Biomedical, Inc.) (K944068) Restore® Self-Tapping Dental<br>Implant System, SD (Lifecore<br>Biomedical, Inc.) (K951111) Renova™ Internal Hex Implant<br>System (Lifecore Biomedical, Inc.)<br>(K032774) PrimaSolo™ One-Piece Implant<br>System (Lifecore Biomedical, Inc.)<br>(K050506) |
## 3. Device Description
The Lifecore Biomedical PrimaConnex Internal Connection Implant System consists of two-stage, root-form tapered and straight-walled threaded dental implants and associated abutment systems, which provide the clinician with
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K05/6/4
#### Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System
screw-retained, cement-retained, and overdenture abutments. The system also includes surgical and restorative instrumentation: twist drills, surgical taps, surgical depth probe, depth gauges, abutment drivers, latch-type drivers, and hand-piece adapters. Lifecore PrimaConnex implants are available with a Resorbable Blast Media (RBM) roughened surface. All implants have an internal connection as an anti-rotational feature for the prosthetics.
#### 4. Intended Use
Lifecore Biomedical Dental Implants are intended for use intended for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including: cement retained, screw retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework.
The PrimaConnex™ Internal Connection Implant is a threaded implant that is intended for immediate placement and can be restored with a temporary prosthesis in single tooth and multiple tooth applications with good quality bone.
### 5. Substantial Equivalence Comparison
The PrimaConnex Internal Connection Implant System has a substantially equivalent intended use as the identified predicates. All implants are intended for replacing missing teeth and supporting single or multiple-unit restorations in the mandible or maxilla. The Lifecore PrimaConnex Internal Connection Implants are similar in fundamental scientific technology to the predicate devices in that they are all threaded, root form implants constructed of titanium. The subject and predicate devices are similar in size and materials, are sterilized via gamma irradiation and intended for single use only. The PrimaConnex Internal Connection Implant System and the predicates include instruments to assist with the implant procedure. When compared with the predicate devices, no new
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K051614
#### Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaConnex™ Internal Connection Implant System
questions of safety or effectiveness have been raised for the PrimaConnex Internal Connection Implant System.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a stylized abstract symbol resembling a bird or human figure with three curved lines, enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" is arranged around the upper portion of the circle.
SEP - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Rachel Kennedy Regulatory Affairs Manager Lifecore Biomedical, Incorporated 3515 Lyman Blvd. Chaska, Minnesota 55318-3015
Re: K051614
KUJ1014
Trade/Device Name: PrimaConnex™ Internal Connection Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous dental implant Regulatory Class: II Product Code: DZE Dated: June 16, 2005 Received: June 17, 2005
Dear Ms. Kennedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your becamer of the device is substantially equivalent (for the relerenced above and have determined te to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Interstate commerce prior to that have been reclassified in accordance with the provisions of Alliendlinens, of to dovrees that in tic Act (Act) that do not require approval of a premarket the rederal I ood, Drug, and Ocements , therefore, market the device, subject to the general approval approvisions of the Act. The general controls provisions of the Act include controls provisions of the ristration, 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 If your device is classified (see above) into sontrols. Existing major regulations affecting g (PMA), it may of subject to back additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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#### Page 2 - Ms. Kennedy
Please be advised that FDA's issuance of a substantial equivalence determination does not r least be advisod that I Dr. o to mination that your device complies with other requirements Incall that I DTT mas mass statutes and regulations administered by other Federal agencies. of the Act of ally I oderal but is requirements, including, but not limited to: registration T ou inust comply with as 807); labeling (21 CFR Part 801); good manufacturing practice and listing (21 CF R Part 807), caselling systems (QS) regulation (21 CFR Part 820); and if requirements us set form in are quadiation 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) This teller will anow you to began finding of substantial equivalence of your device to a premarket notification. - The Fire 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), if you desire specific and Compliance 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 overn banel 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/industry/support/index.html.
Sincerely yours,
Clu
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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# Indications for Use
## 510(k) Number (if known): K051614
PrimaConnex™ Internal Connection Implant System Device Name:
#### Indications for Use:
Indications for Use:
Lifecore Biomedical Dental Implants are intended for use in partially or fully Lifecore Biomedical Dental Implant System informations on the prouting including,
edentulous mandibles and maxillae, in support of single or intermediate edentulous mandibles and maxiliae, in support of singlo of millions of intermediate abutment support for fixed bridgework.
The PrimaConnex Internal Connection Implant is a threaded internal connection implant. The The PrimaConnex Internal Connection Implant is intended for immediate placement, where PrimaConnex Internal Connection in the local relines of Oral Implantologists
immediate implant placement is defined by the lother into the extraction socket immediate implant placement is delined by the memational only outs of the extraction socket.
(ICOI) as the placement of an implant at the time of tooth extraction socket.
The PrimaConnex Internal Connection Implant is intended for immediation,
Andress of Connection Production in discripcd by the International Congress of The PrimaConnex internal Connection in international on the International Congress of
non-occlusal load. Immediate Provisionalization is discreational of an interim prosthes non-occlusal load. Immediate Provisionalization for the placement of an interim prosthesis with
Oral Implantologists (ICOI) as a clinical protocol for the same clinical visi Oral Implantologists (ICO) as a Cinical proceed for the same clinical visit of implant
or without occlusal contact with the opt of the same clinical visit a tempor or without occlusal contact will the opposing the on be restored with a temporary
placement. The PrimaConnex Internal Connection with and erestored with a temporary placement. The PrimaConnex internal Gonnection maps
prosthesis in single tooth and multiple tooth applications with good quality bone.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Page 1 of __1_
Susan Ruanor
Division of Anesthesiology, General Hose Infection Control, Dental D
510(k) Number: K051614
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.
