(219 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.
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 using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via validated Straumann milling.
The provided text describes a 510(k) submission for Straumann® Variobase™ Abutments, detailing the device, its intended use, and performance testing. However, it does not include the specific acceptance criteria or the full study details needed to populate all sections of your request comprehensively. The text primarily focuses on bench testing for fatigue limits and establishing substantial equivalence to predicate devices, rather than a clinical study evaluating diagnostic performance against defined acceptance criteria.
Based on the provided document, here's what can be extracted and what information is missing:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Explicitly Stated for diagnostic metrics. The document mentions "requirements of ISO 5832-11" for material and evaluation of "fatigue load limits" in accordance with "FDA guidance document 'Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments'". These are performance standards for mechanical properties, not diagnostic accuracy. | Not Explicitly Stated for diagnostic metrics. The study focused on evaluating "fatigue load limits" of the abutments and confirming the material meets ISO 5832-11. The document concludes "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." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not applicable in the context of diagnostic performance as described. The testing involved mechanical bench testing of components (Polycon® ae and Zerion®) rather than a test set of patient data.
- Data Provenance: Not applicable. The tests were bench tests conducted on device components, not on patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This was a mechanical performance study, not a study requiring expert-established ground truth for diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was a mechanical performance study.
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
- No. This is a traditional 510(k) for a dental abutment, focusing on material and mechanical properties, not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. Not an AI diagnostic device.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not applicable in the context of diagnostic performance. For the mechanical testing, the "ground truth" would be established by the engineering standards and test methodology (e.g., ISO 5832-11 and FDA guidance for fatigue testing), rather than clinical ground truth.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not applicable. This is not an AI/machine learning device.
Summary of what is described in the 510(k):
The submission describes the Straumann® Variobase™ Abutments as pre-manufactured (stock) abutments made from a titanium-aluminum-niobium alloy (meeting ISO 5832-11). Performance testing involved bench testing to evaluate the fatigue load limits in accordance with FDA guidance for Class II dental implants and abutments. This testing was to demonstrate substantial equivalence to predicate devices (K120822 and K111935) and confirm that the device does not pose new safety or effectiveness issues. The materials for the coping/crown component were also identical to predicate devices. The focus is on the mechanical and material properties of the abutment to support prosthetic restorations.
{0}------------------------------------------------
Traditional 510(k) Submission
Straumann® Variobase™ Abutments
FEB 21 2014
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
1-978-747-0023 Fax Number:
Contact Person: Jennifer M. Jackson, MS
Date of Submission: 20-Feb-2014
5.2 Name of the Device
| Trade Name: | Straumann® Variobase™ Abutments |
|---|---|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Number: | §872.3630 |
5.3 Predicate Device(s)
- K120822, Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC . (Institut Straumann AG)
- K111935. Ti-Base Abutment (NT-Trading GmbH & Co. KG) 0
Device Description 5.4
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
{1}------------------------------------------------
Traditional 510(k) Submission
Straumann® Variobase™ Abutments
510(k) Summary
dental laboratory using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via validated Straumann milling.
5.5 Intended Use
Straumann® Variobase " Abutments are pre-manufactured (stock) abutments intended to be placed onto Straumann dental implants to provide support for customized prosthetic restorations such as crowns and bridges. Straumann® Variobase " Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.
Technological Characteristics 5.6
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 using open CAD software and manufactured via validated Straumann milling.
The Ti-base components of the Straumann® Variobase™ Abutments are identical to the Ti-base components of the Straumann predicate (K120822). The Ti-base components are also equivalent to the Ti-base components identified in K111935.
The 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:
Polycon® ae (temporary restorations - K120822) Milling: Zerion® (K120822)
5.7 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 Polycon® ae and Zerion® to evaluate the fatigue load limits of the proposed Straumann® Variobase™ Abutments. Dynamic fatigue tests were conducted in according to the FDA guidance document "Guidance for Industry and FDA
5-2
{2}------------------------------------------------
Traditional 510(k) Submission
Straumann® Variobase™ Abutments
510(k) Summary
Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".
5.8 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.
{3}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 21, 2014
Straumann USA. Limited Liability Company Jennifer M. Jackson, MS 60 Minuteman Road Andover, MA 01810
Re: K132219
Trade/Device Name: Straumann® Variobase ™Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Abutment, Implant, Dental, Endosseous Regulatory Class: II Product Code: NHA Dated: January 23, 2014 Received: January 24, 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.
{4}------------------------------------------------
Page 2 - Ms. Jackson
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 device-related 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 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
Sincerely yours.
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Image /page/4/Picture/7 description: The image shows the name "Kwame Oulmers" in a stylized font. The letters are bold and black, with a textured pattern inside each letter. The name is arranged in two lines, with "Kwame" on the top and "Oulmers" on the bottom. The letters are slightly overlapping, creating a sense of unity and cohesion.
for
Erin I. Keith, M.S. Acting 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): K 13 2219
Device Name: Straumann® Variobase™ Abutments
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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
Image /page/5/Figure/10 description: The image contains a logo with the words "San Diego" on the left side. On the right side of the logo, the words "Marathon Runner -5" are written. Below that, the number "1" is written, and below that, the number "05'00" is written.
Page 1 of 1
§ 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.)