(98 days)
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase™ Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann® Variobase" Abutments are available to fit Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow for pressing, or milling using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.
The purpose of this submission is to add coping and/or crown materials to the Straumann® Variobase™ Abutment portfolio for the previously cleared validated Straumann milling workflow and to expand the design/manufacturing workflow to include in-lab pressing and casting techniques and materials.
The provided text describes Straumann Variobase Abutments and their substantial equivalence to predicate devices, but it does not contain the detailed study information, acceptance criteria, or performance data typically found in a clinical study report.
The document specifically states under section "5.8 Performance Testing": "Bench testing was performed with each coping/crown material to evaluate the performance of the proposed Straumann® Variobase™ Abutments. Dynamic fatigue tests were conducted in according to the FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'."
This indicates that bench testing was performed, but the results, specific acceptance criteria, sample sizes, and other detailed information requested are not present in this 510(k) summary document. Without this information, I cannot fulfill all parts of your request.
However, I can extract the information that is present:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: While specific numerical acceptance criteria are not presented in this document, the general criterion is that the device must meet the requirements of the FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" through dynamic fatigue tests. The overall conclusion is that the device is "substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness."
- Reported Device Performance: The document states that "Bench testing was performed with each coping/crown material to evaluate the performance of the proposed Straumann® Variobase™ Abutments." No quantitative performance metrics (e.g., fatigue strength, cycles to failure) are provided in this summary.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text.
- Data Provenance: The document refers to "Bench testing," which is typically laboratory-based. The location or specific origin of this data (e.g., country) is not mentioned. It is by nature retrospective for this submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. This was bench testing, not a clinical study involving experts establishing ground truth for a test set in the conventional sense of diagnostic device evaluation.
4. Adjudication method for the test set:
- Not applicable/Not specified. This was bench testing.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a submission for dental abutments, not an AI/diagnostic imaging device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is for dental abutments, not a standalone algorithm.
7. The type of ground truth used:
- For the bench testing, "ground truth" would be established by the physical testing methods and engineering standards outlined in the FDA guidance document for dynamic fatigue tests. This is a form of physical measurement/engineering standard rather than clinical ground truth (e.g., pathology).
8. The sample size for the training set:
- Not applicable. This document describes bench testing for structural integrity of a medical device, not a machine learning model that requires a "training set."
9. How the ground truth for the training set was established:
- Not applicable. (No training set for an AI model).
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing to the right, connected by a flowing ribbon-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 9,2015
Straumann USA, LLC Jennifer M. Jackson M.S. Senior Regulatory Affairs Project Manager 60 Minuteman Road Andover, MA 01810
Re: K142890
Trade/Device Name: Straumann Variobase Abutment NNC, Straumann Variobase Abutment RN, Straumann Variobase Abutment WN, Straumann Variobase Abutment NC, Straumann Variobase Abutment RC, IPS e.max CAD MO Coping, IPS e.max CAD LT Crown, IPS e.max CAD HT Crown, coron CoCr Single Unit Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 22, 2014 Received: December 23, 2014
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.
{1}------------------------------------------------
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,
Susan Russo, DDS, MA
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
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K142890
Device Name
Strauman® Variobase™ Abutment NNC, Strauman® Variobase™ Abutment RN, Strauman® Variobase™ Abutment WN, Strauman® Variobase™ Abutment NC, Strauman® Variobase™ Abutment RC, IPS e.max® CAD MO Coping, IPS e.max® CAD LT Crown, IPS e.max® CAD HT Crown, coron CoCr Single Unit
Indications for Use (Describe)
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Strauman® Variobase™ Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase™ Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Druq Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Straumann® Variobase™ Abutments
510(k) Summary
510(k) Summary 5
Submitter's Contact Information 5.1
Straumann USA, LLC (on behalf of Institut Straumann AG)
60 Minuteman Road
Andover, MA 01810
Phone Number: 1-978-747-2509
Fax Number: 1-978-747-0023
Contact Person: Jennifer M. Jackson, MS
Date of Submission: January 8, 2015
5.2 Name of the Device
| Trade Name: | Straumann® Variobase™ Abutment NNC, Straumann® Variobase™ Abutment RN, Straumann® Variobase™ Abutment WN,Straumann® Variobase™ Abutment NC, Straumann® Variobase™ Abutment RC, IPS e.max® CAD MO Coping, IPS e.max® CAD LT Crown, IPS e.max® CAD HT Crown, coron CoCr Single Unit |
|---|---|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Number: | §872.3630 |
Predicate Device(s) 5.3
- K120822, Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC . (Institut Straumann AG)
- K120053, IPS e.max® Press Abutment Solutions (Ivoclar Vivadent AG) ●
- K132209, IPS e.max® CAD Abutment Solutions (Ivoclar Vivadent AG) ●
- K132219, Straumann Variobase Abutments ●
{4}------------------------------------------------
Straumann® Variobase™ Abutments
510(k) Summary
5.4 Device Description
The Straumann® Variobase™ Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann® Variobase" Abutments are available to fit Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow for pressing, or milling using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.
The purpose of this submission is to add coping and/or crown materials to the Straumann® Variobase™ Abutment portfolio for the previously cleared validated Straumann milling workflow and to expand the design/manufacturing workflow to include in-lab pressing and casting techniques and materials.
5.5 Intended Use
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase" Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
5.6 Indications for Use
The Straumann® Variobase™ Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase"" Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase"" Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.
{5}------------------------------------------------
Straumann® Variobase™ Abutments
510(k) Summary
5.7 Technological Characteristics
Straumann® Variobase™ Abutments are two-piece abutments consisting of a premanufactured (stock) abutment made from a titanium-aluminum-niobium alloy and a coping and/or crown which is designed in the dental laboratory by a dental technician and manufactured via traditional in-lab methods of pressing or via validated Straumann milling.
The Ti-base components of the Straumann® Variobase™ Abutments are identical to the Ti-base components of the Straumann predicates (K120822 and K132219). The CAD and press materials which may be used to manufacture the coping/crown component of the Straumann Variobase Abutments are identical to the identified predicate devices and include:
| Casting: | Type 4 metals (ISO 22674) |
|---|---|
| Base metal alloy (e.g., cobalt-chromium (CoCr) | |
| Noble metal alloy (e.g., gold alloy) | |
| Pressing: | IPS e.max® Press Ceramic (K120053) |
| CAD: | IPS e.max® CAD Ceramic (K132209) |
| coron® |
5.8 Performance Testing
The material used in the manufacture of Straumann® Variobase™ Abutments is a titanium-aluminum-niobium alloy which meets the requirements of ISO 5832-11. Bench testing was performed with each coping/crown material to evaluate the performance of the proposed Straumann® Variobase™ Abutments. Dynamic fatigue tests were conducted in according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".
{6}------------------------------------------------
Straumann® Variobase™ Abutments
510(k) Summary
5.9 Conclusion
The documentation submitted in this premarket notification demonstrates that the Straumann® Variobase™ Abutments are substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness when used as labeled.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)