FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS TPS COATING; FRIALIT-2 3.4MM STEEPED CYLINDER IMPLANT WITH FRIOS HA
Applicant
Friadent GmbH
Product Code
DZE · Dental
Decision Date
Mar 24, 2000
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The FRIALIT-2® 3.4mm dental implant is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
Device Story
FRIALIT-2® 3.4mm Dental Implant is an endosseous dental implant; available as stepped cylinder with FRIOS® TPS (titanium plasma sprayed) or FRIOS® HA (hydroxylapatite) coating, or stepped screw-type with FRIOS® Deep Profile Surface. Used by dental surgeons to replace missing teeth; provides foundation for prosthetic restorations including single crowns, bridges, and overdentures. Implant placed into jawbone; integrates with bone to support dental prosthetics. Benefits include restoration of oral function and aesthetics for patients with tooth loss. Device is used in clinical dental settings.
Clinical Evidence
Bench testing only. Substantial equivalence established via mechanical performance testing, specifically 30° compression/bending testing and cyclic loading fatigue testing, comparing the subject device to the predicate.
Technological Characteristics
Endosseous dental implant; stepped cylinder or stepped screw-type geometry. Coatings: FRIOS® TPS (titanium plasma sprayed) or FRIOS® HA (hydroxylapatite) or FRIOS® Deep Profile Surface. Materials and design are identical to existing FRIALIT-2® system components.
Indications for Use
Indicated for patients requiring single tooth restoration, restoration of edentulous spans with multiple single teeth, free-standing bridges, or overdenture retention. Suitable for immediate, delayed immediate, or late implant placement following tooth extraction.
Regulatory Classification
Identification
An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.
Special Controls
*Classification.* (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
*Classification.* Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.
Predicate Devices
Branemark System Standard 3.75mm Fixture (K925765)
Submission Summary (Full Text)
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#### SUMMARY OF SAFETY AND EFFECTIVENESS SECTION 16:
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and CFR 807.92.
## SUBMITTER INFORMATION 16.1
| a. Company Name: | FRIADENT GmbH. |
|-----------------------------------------|-----------------------------------------------------------|
| b. Company Address: | Steinzeugstrasse 50<br>Mannheim D-68229<br>Germany |
| c. Company Phone:<br>Company Facsimile: | (011) 49 06 21 4 86 1549<br>(011) 49 06 21 4 86 1866 |
| d. Contact Person: | Birgit Unger<br>Quality Management and Regulatory Affairs |
| e. Date Summary Prepared: | December 21, 1999 |
## DEVICE IDENTIFICATION 16.2.
| a. Trade/Proprietary Name: | FRIALIT-2® 3.4mm Dental Implant |
|----------------------------|-----------------------------------------------|
| b. Classification Name: | Endosseous Dental Implants<br>21 CFR 872.3640 |
## 16.3 IDENTIFICATION OF PREDICATE DEVICES
| Company | Device | 510(k) No. | Date Cleared |
|---------------|---------------------------------------------|------------|--------------|
| Nobel BioCare | Branemark System Standard<br>3.75mm Fixture | K925765 | 10/05/93 |
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FRIADENT GmbH FRIALIT-2® 3.4mm Dental Implant Original Premarket 510(k) Notification
## DEVICE DESCRIPTION 16.4
The FRIALIT-2® 3.4mm Dental Implant is an addition to the FRIALIT-2® Dental Implant System currently in commercial distribution. The FRIALIT-2® 3.4mm dental implant is available as a stepped cylinder coated with either FRIOS® TPS (titanium plasma sprayed) coating or FRIOS® HA (hydroxylapatite) coating, and a stepped screw-type implant line coated with the FRIOS® Deep Profile Surface. Surgical, prosthetic and laboratory components to facilitate the placement and restoration of the 3.4mm implant have also been designed.
## SUBSTANTIAL EQUIVALENCE 16.5
The FRIALIT-2® 3.4mm dental implant is substantially equivalent to the current FRIALIT-2® Dental Implant Systems in terms of design, materials, coatings and prosthetic options. The FRIALIT-2® 3.4mm dental implant is substantially equivalent to the Nobel BioCare Branemark 3.75mm dental implant in terms of 30° Compression/Bending Testing and Cyclic Loading Fatigue Testing.
The FRIALIT-2® 3.4mm dental implant is equivalent to the current FRIALIT-2® dental implants in design, materials, coatings, prosthetics, function and intended use. The FRIALIT-2® 3.4mm dental implant is equivalent to the Nobel BioCare Branemark 3.75mm dental implant in materials, functionality, mechanical strength and intended use.
### 16.6 INTENDED USE
The FRIALIT-2® 3.4mm dental implant is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, freestanding bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
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## 16.7 TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the FRIALIT-2® 3.4mm dental implant with the predicate devices is provided within this submission. The FRIALIT-2® 3.4mm dental implant is identical to the current FRIALIT-2® dental implants in terms of coatings, materials, prosthetic options and intended use. The FRIALIT-2® 3.4mm dental implant is available in a stepped cylinder with either FRIOS® TPS or FRIOS® HA coating, and as a stepped screw-type with FRIOS® Deep Profile Surface.
## 16.8 CLASS III CERTIFICATION AND SUMMARY
This notification contains a Class III certification and summary of adverse safety and effectiveness information pursuant to 513(f) of the Federal Food, Drug, and Cosmetic Act.
## 16.9 510(K) CHECKLIST
This notification contains all information required by 21 CFR 807.87. A completed copy of the Premarket Notification 510(k) Reviewer's Checklist is provided in this submission.
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Page 2 -Ms. Patterson
obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4690. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Patuna Cincinta/xx
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2000
FRIADENT GmbH C/O Ms. Carol Patterson Consultant Patterson Consulting Group, Inc. 21911 Erie Lane Lake Forest, California 92630
K994376 Re : FRIALIT-2® Dental Implant System Trade Name: Regulatory Class: III Product Code: DZE Dated: December 21, । ਰੇਰੇ ਰੋ Received: December 27, 1999
Dear Ms. Patterson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If vour device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any
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FRIADENT GmbH FRIALIT-2® 3.4mm Dental Implani Original Premarket 510(k) Notification
# INDICATION FOR USE
K994376 510(k) Number
FRIALIT-2® Dental Implant System Device Name:
Indications for Use: The FRIALIT-2® Dental Implant System is intended for use in single tooth restoration, edentulous spans restored with multiple single teeth, free-standing bridges and to retain overdentures. The implants can be used after extraction for immediate implant placement, delayed immediate implant placement or late implant placement.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Suarez
(Division Sign-Off) Division of Dental, Infection Control, and General Hospita 510(k) Number
Prescription Use v
OR
Over-The-Counter Use
(Per 21 CFR 801 . 109)
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.
