K153758 · Institut Straumann AG · DZE · Mar 23, 2016 · Dental
Device Facts
Record ID
K153758
Device Name
Straumann Bone Level Tapered Implants
Applicant
Institut Straumann AG
Product Code
DZE · Dental
Decision Date
Mar 23, 2016
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 872.3640
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Device Story
Straumann Bone Level Tapered Implants are endosseous dental implants designed for oral rehabilitation. This device is a line extension of previously cleared implants (K140878), introducing an 18 mm length option. The implants are surgically placed into the jawbone by dental professionals to support prosthetic restorations, including single crowns, bridges, and dentures. The device is manufactured from a titanium-13zirconium alloy (Roxolid) with SLA or SLActive surface finishes. The system utilizes Narrow CrossFit (NC) or Regular CrossFit (RC) implant-to-abutment interfaces. The primary clinical benefit is the restoration of chewing function and esthetics for patients with missing teeth. The device is used in a clinical setting; the surgeon performs the implantation, and the restorative dentist manages the prosthetic connection. The 18 mm length provides an additional option for specific anatomical requirements, with performance validated through bench testing, including dynamic fatigue and insertion torque analysis in simulated bone material.
Clinical Evidence
Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, biological compatibility per ISO 10993, sterilization validation per ISO 11137, and shelf-life stability per ASTM F1980. Additional bench testing measured peak insertion torque in simulated bone material (polyurethane foam, 10-40 pcf) to validate the 18 mm length and 3.3 mm diameter design.
Technological Characteristics
Material: Titanium-13zirconium alloy (Roxolid) for implants; Titanium-6aluminum-7niobium alloy (TAN) for transfer pieces. Surface: SLA or SLActive. Dimensions: 3.3, 4.1, 4.8 mm diameters; 18 mm length. Connection: Narrow CrossFit (NC) or Regular CrossFit (RC). Sterilization: ISO 11137 series. Mechanical: Constant major/minor thread diameter (parallel wall), 0.8 mm pitch.
Indications for Use
Indicated for edentulous and partially dentate patients requiring oral endosteal implantation in the upper or lower jaw for functional and esthetic rehabilitation. Suitable for immediate or early implantation post-extraction/tooth loss and immediate function in single or multiple tooth applications, provided primary stability and appropriate occlusal loading are achieved.
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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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 23, 2016
Institut Straumann AG c/o Ms. Jennifer Jackson. M.S. Head of Regulatory Affairs and Quality Straumann USA. Inc. 60 Minuteman Road Andover, Massachusetts 01810
Re: K153758
Trade/Device Name: Straumann® Bone Level Tapered Implants Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: December 29, 2015 Received: December 30, 2015
Dear Ms. Jackson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Tina Kiang -S
for Erin I. Keith, M.S. Director Division of Anesthesiology. General Hospital, Respiratory, 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) K153758
Device Name
Straumann® Bone Level Tapered Implants
Indications for Use (Describe)
Straumann® Bone Level Tapered Implants are indicated for oral endosteal implantation in the upper and lower jaw and for the functional and esthetic oral rehabilitation of edentulous and partially dentate patients. Straumann Bone Level Tapered Implants can also be used for immediate or early implantation following extraction or loss of natural teeth. Implants can be placed with immediate function on single-tooth and/or multiple tooth applications when good primary stability is achieved and with appropriate occlusal loading, to restore chewing function. The prosthetic restorations used are single crowns, bridges and partial or full dentures, which are connected to the implants by the corresponding elements (abutments).
Type of Use (Select one or both, as applicable)
> Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 5. | 510(k) Summary | K153758 |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
| | Contact Person: | Jennifer Jackson, MS<br>Head of Regulatory Affairs and Quality<br>(978) 747-2509 |
| | Prepared By: | Christopher Klaczyk<br>Head of North American Regulatory Affairs<br>+41 79 915 8367 |
| | Date Prepared: | March 7, 2016 |
| | Product Code(s): | DZE (21 CFR 872.3640) |
| | Device Class: | II (21 CFR 872.3640) |
| | Classification Panel: | Dental |
| | Classification Name: | Endosseous dental implant (21 CFR 872.3640) |
| | Proprietary Name: | Straumann® Bone Level Tapered Implant |
| | Predicate Device:: | Straumann Bone Level Tapered Implants (K140878) |
| | Reference Device(s): | Straumann Roxolid SLA Implants (K150938)<br>Neodent CM Drive Line Extension (K150182) |
| | Device Description: | The subject devices represent a line extension of the previously<br>cleared Bone Level Tapered Implants of the Straumann Dental<br>Implant System (K140878 and K150938). The subject devices<br>have the same diameters (3.3, 4.1 and 4.8 mm), the same<br>implant-to-abutment interfaces (NC, RC), the same material<br>(Ti-13Zr) and the same surface finishes (SLA, SLActive) as the<br>identified primary predicate devices. The subject devices differ<br>in that the lengths are 18 mm versus a maximum length for the<br>primary predicate devices of 16 mm. |
| Intended Use:<br>Bone Level Tapered<br>Implants | Straumann® Bone Level Tapered Implants are indicated for oral<br>endosteal implantation in the upper and lower jaw and for the<br>functional and esthetic oral rehabilitation of edentulous and<br>partially dentate patients. Straumann Bone Level Tapered<br>Implants can also be used for immediate or early implantation<br>following extraction or loss of natural teeth. Implants can be<br>placed with immediate function on single-tooth and/or multiple<br>tooth applications when good primary stability is achieved and<br>with appropriate occlusal loading, to restore chewing function.<br>The prosthetic restorations used are single crowns, bridges and<br>partial or full dentures, which are connected to the implants by<br>the corresponding elements (abutments). | |
| Materials: | Versions of the subject devices will be produced from a<br>titanium-13zirconium alloy, trade named Roxolid®, as<br>previously reviewed and cleared to market per premarket<br>notification submission K140878.<br><br>The transfer piece is produced from titanium-6aluminum-<br>7niobium alloy (TAN). This is the same material as for the<br>predicate transfer pieces cleared to market per premarket<br>notification submission K140878. | |
| Technological<br>Characteristics: | The subject devices are identical in every respect to the<br>identified Bone Level Tapered predicate devices with the<br>exception of overall length; the subject device is 18 mm in<br>length where the longest previously cleared Bone Level<br>Tapered devices previously cleared to market per K140878 and<br>K150938 is 16 mm in length.<br><br>The 18 mm length subject devices have the same length as the<br>Neodent CM Drive device cleared to market per K150182,<br>however the Neodent CM Drive devices have a minimum<br>diameter of Ø3.5 mm where the subject device has a minimum<br>diameter of Ø3.3 mm. | |
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| Feature | Primary Predicate Device<br>Bone Level Tapered Implants<br>(K140878) | Subject Devices<br>Bone Level Tapered Implants |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Straumann® dental implants are indicated<br>for oral endosteal implantation in the<br>upper and lower jaw and for the<br>functional and esthetic oral rehabilitation<br>of edentulous and partially dentate<br>patients. Straumann dental implants can<br>also be used for immediate or early<br>implantation following extraction or loss<br>of natural teeth. Implants can be placed<br>with immediate function on single-tooth<br>and/or multiple tooth applications when<br>good primary stability is achieved and<br>with appropriate occlusal loading, to<br>restore chewing function. The prosthetic<br>restorations used are single crowns,<br>bridges and partial or full dentures, which<br>are connected to the implants by the<br>corresponding elements (abutments). | Straumann® Bone Level Tapered Implants<br>are indicated for oral endosteal<br>implantation in the upper and lower jaw<br>and for the functional and esthetic oral<br>rehabilitation of edentulous and partially<br>dentate patients. Straumann Bone Level<br>Tapered Implants can also be used for<br>immediate or early implantation<br>following extraction or loss of natural<br>teeth. Implants can be placed with<br>immediate function on single-tooth and/or<br>multiple tooth applications when good<br>primary stability is achieved and with<br>appropriate occlusal loading, to restore<br>chewing function. The prosthetic<br>restorations used are single crowns,<br>bridges and partial or full dentures, which<br>are connected to the implants by the<br>corresponding elements (abutments). |
| Implant-to-Abutment<br>Connection | Narrow CrossFit® (NC)<br>Regular CrossFit® (RC) | Narrow CrossFit® (NC)<br>Regular CrossFit® (RC) |
| Implant Diameter | Ø3.3mm, Ø4.1mm, Ø4.8mm | Ø3.3mm, Ø4.1mm, Ø4.8mm |
| Implant Length | 8, 10, 12, 14, 16 mm | 18 mm |
| Coronal Thread Form | Constant major and minor thread<br>diameters (i.e., parallel wall)<br>0.8mm thread pitch | Constant major and minor thread<br>diameters (i.e., parallel wall)<br>0.8mm thread pitch |
| Material | Titanium Grade 4<br>Titanium zirconium alloy Ti-13Zr | Titanium zirconium alloy Ti-13Zr |
| Surface Finish | SLA<br>SLActive | SLA<br>SLActive |
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| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special<br>Controls Guidance Document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments dated May 12,<br>2004, the substantial equivalence of the subject device(s) are<br>satisfactorily addressed via bench studies. The following<br>studies are incorporated into this submission by reference to the<br>submission for the primary predicate (K140878):<br>Dynamic fatigue test data consistent with FDA guidance<br>and ISO 14801Biological compatibility per the ISO 10993 series standardsSterilization validation per the ISO 11137 series standardsShelf life (stability) per ASTM F1980 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | In order to confirm that the reduced minimum implant diameter<br>between the subject device (Ø3.3 mm) and the Neodent CM<br>Drive reference device (Ø3.5 mm) does not result in a new<br>failure mode, the following additional bench study was<br>performed on all three diameters of the subject device:<br>Peak insertion torque was measured while driving the<br>implants to a clinically appropriate position relative to the<br>surface of simulated bone material (polyurethane foam)<br>having densities of between 10 and 40 pounds per cubic<br>foot that had been prepared per the instructions for use. |
| Conclusions: | Based upon our assessment of the design and applicable<br>performance data, the subject devices have been determined to<br>be substantially equivalent to the identified predicate devices. |
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.
