Published clinical literature; Consensus statements (American Dental Association, McGill Consensus, York Consensus)
The sponsor used a review of clinical literature and professional consensus statements to demonstrate that the use of two immediately loaded dental implants is equivalent to the use of four or more implants for the treatment of fully edentulous patients, supporting the expansion of the device's Indications for Use.
Clinical literature review; Consensus statements; Immediate loading; Edentulous patients
Clinical Evidence
Study Design
Population
Comparator
Key Endpoints
Review of clinical literature and consensus statements; Literature review and consensus statement analysis
Fully edentulous patients
Greater number of implants (e.g., four or more)
Performance of two immediately loaded dental implants compared to standard of care
Indications for Use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated 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 through the corresponding components (abutments).
Device Story
Straumann Dental Implant System (SLActive and Roxolid families) consists of endosseous root-form implants placed in upper/lower jaw arches; used by dental professionals for functional/aesthetic rehabilitation of edentulous/partially dentate patients. Implants support single crowns, bridges, or dentures via abutments. Device allows immediate/early implantation post-extraction and immediate function if primary stability is achieved. Clinical benefit includes restored chewing function and aesthetics. This submission specifically modifies indications to remove the requirement for at least four implants when treating fully edentulous patients with immediate loading, supported by consensus statements (McGill/York) favoring two-implant restoration.
Clinical Evidence
No new clinical trials were conducted. Evidence consists of a review of clinical literature and consensus statements (American Dental Association, McGill Consensus, York Consensus) supporting the use of two immediately loaded dental implants for fully edentulous patients. Literature indicates that two-implant restoration is a common, effective treatment and is equivalent to using a greater number of implants for this indication.
Technological Characteristics
Endosseous root-form dental implants. Materials, surface treatments (SLActive/Roxolid), and fundamental operating principles are identical to predicate devices. No changes to surgical instruments or secondary components. Sterilization procedures remain unchanged.
Indications for Use
Indicated for edentulous and partially dentate patients requiring oral endosteal implantation in upper or lower jaw arches for functional and aesthetic rehabilitation. Suitable for immediate or early implantation post-extraction or tooth loss. Supports immediate function for 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.
Predicate Devices
K033922, Modification to ITI Dental Implant System
K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System
K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants
K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants
K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families
Submission Summary (Full Text)
{0}------------------------------------------------
# K1302222
# Traditional 510(k) Submission.
Change in Straumann Dental Implant Indications for Use
APR 2 9 2013
#### 5. 510(k) Summary
#### Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
| Contact Person: | Jennifer M. Jackson, MS or | Christopher Klaczyk |
|-----------------|----------------------------|---------------------|
| Phone Number: | 1-978-747-2509 | 1-978-747-2575 |
| Fax Number: | 1-978-747-0023 | 1-978-747-0023 |
Date of Submission: 28-Jan-2013
#### 5.1 Name of the Device
| Trade Name: | Straumann® Dental Implant System |
|-------------|---------------------------------------|
| | SLActive and Roxolid Product Families |
Common Name: Dental Implants
Classification Name: Implant, Endosseous, Root-form
Regulation Number: §872.3640
#### 5.2 Predicate Device(s)
K033922, Modification to ITI Dental Implant System
K033984, ITI Dental Implant System
K053088, SLActive Implants
K062129, P.004 Implants
K081419, Modified Dental Implant
K083550, Modified Dental Implant
K111357, Narrow Neck CrossFit (NNC) Ø3.3 mm Dental Implant System
K121131, Straumann Bone Level Ø4.1 mm and Ø4.8 mm Regular Connection (RC) Roxolid Dental Implants
K122855, Straumann Tissue Level Ø4.1 mm and Ø4.8 mm Roxolid Dental Implants
K123784, Straumann Dental Implant System - SLA, SLActive and Roxolid Product Families
{1}------------------------------------------------
# Traditional 510(k) Submission
Change in Straumann Dental Implant Indications for Use
#### Device Description 5.3
The subject devices of the Straumann® Dental Implant System includes the following: SLActive® and Roxolid®, Standard, Ø3.3 RN, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.1 RN, 6, 8, 10, 12, 14 & 16 mm SLActive® and Roxolid®, Standard, Ø4.8 RN, 6, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Standard, Ø4.8 WN, 6, 8, 10 & 12 mm SLActive® and Roxolid®, Standard Plus, Ø3.3 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid® Standard Plus, Ø4.1 RN and Ø4.8 RN, 6. 8. 10. 12 & 14 mm SLActive® and Roxolid®, Standard Plus, Ø4.8 WN, 6, 8, 10, & 12 mm Roxolid®, Standard Plus, Ø4.8 WN, 14 mm SLActive® and Roxolid®, Tapered Effect, Ø3.3 RN and Ø4.1 RN, 8, 10, 12 & 14 mm SLActive® and Roxolid®, Tapered Effect, Ø4.8 WN, 10, 12 & 14 mm SLActive® and Roxolid®, Bone Level, Ø3.3 NC, Ø4.1 RC, and Ø4.8 RC, 8, 10, 12 & 14 mm
#### 5.4 Indications For Use / Intended Use
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated 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 through the corresponding components (abutments).
#### 5.5 Technological Characteristics
The subject devices are identical to the corresponding Straumann predicate devices as far as design, materials, surface treatments, fundamental operating principles, and sterilization processes and procedures. The change proposed in this premarket notification modifies the Indications for Use for the SLActive® and Roxolid® dental implants.
There are no changes to or new surgical instruments or secondary components being introduced as a result of the proposed change.
#### 5.6 Performance Testing
The bench and animal performance testing previously submitted in support of the referenced Straumann predicate devices were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and continues to be representative of the performance of the subject devices.
A review and summarization of the clinical literature associated with the use of two immediately loaded dental implants in the treatment of fully edentulous patients. The available data indicate that the use of two dental implants to treat fully edentulous patients is common; the evidence supports that performance of two immediately loaded dental implants is equivalent to the use of a greater number of implants for this indication. We also provide
{2}------------------------------------------------
## Change in Straumann Dental Implant Indications for Use
consensus statements from the American Dental Association, the McGill Consensus and the York Consensus indicating that two implant restoration of fully edentulous mandibles should be the treatment of choice. This literature strongly supports the elimination of the limitation requiring the use of at least four dental implants for the treatment of the fully edentulous patient when the implants are to be immediately loaded.
#### 5.7 Conclusion
The documentation submitted in this premarket notification supports the proposed modification to the Indications for Use of the SLActive® and Roxolid® dental implants. The subject devices are substantially equivalent to the predicate devices.
{3}------------------------------------------------
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66 Silver Spring, MD 20993-0002
## April 29, 2013
Ms. Jennifer M. Jackson, MS Senior Regulatory Affairs Project Manager Straumann USA, Limited Liability Company 60 Minuteman Road ANDOVER MA 01810
Re: K130222
Trade/Device Name: Straumann® Dental Implant System SLActive and Roxolid Product Families Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: January 28, 2013 Received: January 29, 2013
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.
{4}------------------------------------------------
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-GFR-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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/Medica!Devices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame O. Ulmer -S for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
## Indications for Use
510(k) Number (if known); K130222
Device Name:
Straumann® Dental Impiant System SLActive and Roxolid Product Families
### Indications for Use:
Straumann® Dental implants are indicated for oral endosteal implantation in the upper and lower jaw arches for the functional and aesthetic oral rehabilitation of edentulous and partially dentate patients. Straumann® Dental implants are also indicated 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 through the corresponding components (abutments).
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 801 Subpart C)
## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
| Concurrence of CDRH, Office of Device Evaluation (ODE) |
|--------------------------------------------------------|
|--------------------------------------------------------|
| | Digitally signed by Mary S. Runner - S |
|--|----------------------------------------|
| | ON: c=US, o=U.S. Government, |
| | ou=HHS, ou=FDA, ou=People, |
| | cn=Mary S. Runner - S, |
| | 0.9.2342.19200300.100.1.1=13000879 |
| | Date: 2013.04.29 09:55:02 -04'00' |
Susan Runner, DDS, DA
Division Sign-Off) (Division Sign-Sill)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number:
Page 1 of 1
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.
