Lifecore Biomedical Dental Implant System 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.
Device Story
PrimaSolo One-Piece Implant System consists of a machined titanium alloy implant with an integrated abutment; designed for single-stage surgical procedures. System includes healing caps and surgical instrumentation (drills, taps, drivers). Implants feature Resorbable Blast Media (RBM) roughened surface. Used by dental clinicians in clinical settings for immediate placement and temporization of single or multiple-tooth restorations. Device provides structural support for prosthetic teeth; facilitates restoration of chewing function in edentulous or partially edentulous patients.
Clinical Evidence
No clinical data provided. Substantial equivalence is based on technological characteristics and design similarities to legally marketed predicate devices.
Technological Characteristics
One-piece machined titanium alloy implant with integrated abutment. Features Resorbable Blast Media (RBM) roughened surface. Available in various diameters (3.0mm to 5.0mm). System includes manual surgical instrumentation (tissue punches, twist drills, taps, depth probes, drivers). Non-powered, mechanical device.
Indications for Use
Indicated for partially or fully edentulous patients requiring single or multiple-unit restorations (cement/screw-retained or overdentures) or fixed bridgework. 3.5–5.0mm implants are for single-stage surgery and cemented restorations, suitable for immediate placement/temporization in good quality bone. 3.0mm implants are for missing maxillary lateral and mandibular central/lateral incisors; adjacent 3.0mm implants must be splinted.
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 PrimaSolo™ One-Piece Implant System
K050506
## 510(K) SUMMARY AND CERTIFICATION [As required by 21 CFR 807.92(c)]
#### 1. Submitter's Name and Contact Person
| 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 PrimaSolo™ One-Piece Implant<br>System |
|-------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common Name | Endosseous dental implant system |
| Classification Name | Endosseous implant |
| Identification of Predicate Devices | Restore® Self-Tapping Dental Implant System, RD (Lifecore Biomedical, Inc.) (K924589) Restore® Self-Tapping Dental Implant System, WD (Lifecore Biomedical, Inc.) (K944068) Restore® Self-Tapping Dental Implant System, SD (Lifecore Biomedical, Inc.) (K951111) Altiva Immediate Function Dental Implant (Altiva Corporation) (K992512) Replace® One Piece Implant (Nobel Biocare USA, Inc.) (K023952) Nobel Direct (Nobel Biocare USA, Inc.) (K031345) Biohorizons the Maestro System™ 3.0mm Diameter Implant (Biohorizons Implant System, Inc.) (K032351) |
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| | Renova™ Internal Hex Implant<br>System (Lifecore Biomedical, Inc.)<br>(K032774) |
|--|---------------------------------------------------------------------------------|
|--|---------------------------------------------------------------------------------|
### 3. Device Description
The Lifecore PrimaSolo™ One-Piece Implant System is a one-piece implant incorporating both the implant and the abutment into one piece of machined titanium allov. It is designed for one-stage surgical procedures and utilizes cement-retained restorations. It is designed to be used for immediate placement and temporization on single and multiple-tooth restorations. The system also includes healing caps and surgical instrumentation: tissue punches, twist drills, surgical taps, parallel pins, try-ins, surgical depth probe, latch-type implant drivers, and ratchet adapters . Lifecore PrimaSolo One-Piece Implants are available with a Resorbable Blast Media (RBM) roughened surface.
## 4. Intended Use
Lifecore Biomedical Dental Implant System 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.
## 5. Substantial Equivalence Comparison
The Lifecore Biomedical PrimaSolo One-Piece Implant System and the predicate devices Restore® Self-Tapping Implant System (K924589, K944068 and K951111), Renova™ Internal Hex Implant System (K032774), Replace® One Piece Implant (K023952), Nobel Direct (K031345), Biohorizons the Maestro System™ 3.0mm Diameter Implant (K032351), and the Altiva Immediate
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#### Lifecore Biomedical, Inc. Abbreviated 510(k) Premarket Notification PrimaSolo™ One-Piece Implant System
Function Dental Implant (K992512) the share a substantially equivalent intended use. The PrimaSolo and the predicate devices are similar in fundamental scientific technology in that they are all threaded, root form implants constructed of titanium with roughened surfaces. The subject and predicate devices are similar in size and materials. All systems offer an integral abutment feature for cement retained restorations as well as associated accessories and instruments. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the PrimaSolo One-Piece Implant System.
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Image /page/3/Picture/1 description: The image is a seal for the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Public Health Service
APR 1 5 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Lifecore Biomedical, Incorporated Ms. Rachel Kennedy Regulatory Affairs Manager Oral Restorative Division 3515 Lyman Boulevard Chaska, Minnesota 55318-3051
Re: K050506
K050500
Trade/Device Name: PrimaSolo™ One-Piece Implant System Regulation Number: 872.3640 Regulation Name: Endosseous Implant Regulatory Class: II Product Code: DZE Dated: February 25, 2005 Received: March 2, 2005
Dear Ms. Kennedy:
We have reviewed your Section 510(k) premarket notification of intent to market the device We have reviewed your because is = // he device is substantially equivalent (for the referenced above and have acterimined to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device mershale collinered pror to they 20, 777, accordance with the provisions of Allendlichts, of to devroos that is is Act (Act) that do not require approval of a premarket the rederal Pood, Drug, und Ocember , therefore, market the device, subject to the general approval application (1111). controls provisions of the rich. "The genices, good manufacturing practice, requirements for sibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III II your device is classified (see ass roy into seontrols. Existing major regulations affectings (PMA), it may be subject to suer adantenal versions on the 21, Parts 800 to 898. In your device can oc found in the South one of Personal one
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 Flease oe auvisod that I Dri b issuaires on that your device complies with other requirements Incall that 1 271 has made a astes and regulations administered by other Federal agencies. of the Act of ally I ederal backed and equirements, including, but not limited to: registration 1 ou must comply with an 07); labeling (21 CFR Part 801); good manufacturing practice allu listing (21 CFR Pat 067), labeling (21 CFR Part 820); and if requirents as set form in the quartly sion 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) I mis letter will anow you to ough finding of substantial equivalence of your device to a premarket notified.com - The x Breasults 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 for Jour 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 Ifray obtain of Small 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,
Chr L
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): K050506
PrimaSolo™ One-Piece Implant System Device Name:
Indications for Use:
Indications for Use:
Lifecore Biomedical Dental Implants are intended for use in partially or
e in and Siomedical Dental Implant of single or multiple-unit Lifecore Biomedical Dental Infipiant Oyotan unipont of single or multiple-unit
fully edentulous mandibles and maxillae, in support of single or overdenture resto fully edentulous mandibles and intaxiliae, in support on one one one one one of the restorations,
restorations including; cement retained, screw retained, or overdenture res restorations including, centent retailled, coron
and terminal or intermediate abutment support for fixed bridgework.
Specific Intended Uses: The PrimaSolo One-Piece (3.5 – 5.0mm) Implant is a threaded
Specifical Uses: The Primated on tweet designed for single-stage surgical Specific Intended Uses: "The Printations one i for single-stage surgical
one-piece implant with an integrated abutment designed for single-stage surgical one-piece implant with an integrated abunche acception of einended for procedure and cemented restorations: Triniteens only prosthesis in single tooth
immediate placement and can be restored with a temporary prosthesis in single tooth immediate placemontations with good quality bone.
The PrimaSolo One-Piece (3.0mm) Implant is a threaded one-piece implant with an
the end is in The PrimaSolo One-Plece (3.0mm) intellent is a tirrordure and is indicated for integrated abutment designed in Single-Stage of the mandibular central and
use in the treatment of missing maxillary later and in order to restor use in the treatment of missing maxiliary facer their in order to restore
lateral incisors to support prosthetic devices, such as artificial teeth, incisors lateral incisors to support prosthent de news, business of the mail incisors
chewing function in partially edentulous patients adasont to one another chewing function in partially edenturous putionto. The management to one another.
must be splinted if using two or more 3.0mm implants adjacent to one another.
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)
Ken Mubej for HSR
K050506
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.
