(121 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 screwretained 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 purpose of the subject submission is to add the zerion® ML and zerion® UTML Zirconia ceramic materials as a material suitable for fabrication of the coping, crown or bridge that, when bonded to the previously cleared Variobase abutment base (K120822, K142890), forms a finished dental prosthesis. 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. The restoration will be manufactured via validated Straumann milling.
The provided document is a 510(k) summary for the Straumann® Variobase® Abutments, an endosseous dental implant abutment. The primary purpose of this submission is to add new Zirconia ceramic materials (zerion® ML and zerion® UTML Zirconia) as suitable materials for fabricating the coping, crown, or bridge that attach to the Variobase abutment base.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document outlines performance data related to the physical and biological characteristics of the device rather than traditional clinical performance (e.g., diagnostic accuracy metrics like sensitivity, specificity, AUC). The acceptance criteria are based on compliance with established standards and guidance documents.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Material Composition | Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN) meets ISO 5832-11. |
| Dynamic Fatigue Performance | Bench tested according to FDA guidance for Class II Endosseous Dental Implants and Abutments. (Implied successful completion to claim substantial equivalence) |
| Steam Sterilization Validation | Validated per FDA guidance "Reprocessing Medical Devices in Health Care Settings" (March 17, 2015) and ISO 17665 series standards. (Implied successful completion) |
| Cytotoxicity | Tested per ISO 10993-5. (Implied successful completion) |
| Inorganic Extractables/Leachables | Tested per ISO 10993-18. (Implied successful completion) |
| Software Validation | Validated per FDA guidance "General Principles of Software Validation" (January 11, 2002) and IEC 62304. (Implied successful completion) |
| Coping/Crown Material Equivalence (New Zirconia) | zerion® ML & UTML zirconia ceramics are substantially equivalent to previously cleared zerion® HT zirconia ceramics. (Determined through bench testing and material comparison) |
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of abutments for fatigue testing, number of samples for cytotoxicity). It only states that "Bench testing was performed."
- Data Provenance: All testing appears to be retrospective bench testing conducted in vitro (laboratory setting) and pre-clinical. There is no indication of human or animal studies. The country of origin of the data is not explicitly stated but is implied to be conducted by or for Institut Straumann AG, a Swiss company with a US subsidiary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- This information is not applicable in the context of this submission. The "ground truth" for the acceptance criteria mentioned (e.g., material compliance, fatigue limits, sterility, biocompatibility) is established by international standards (ISO) and FDA guidance documents, not by individual experts establishing a "ground truth" on a test set in the same way an expert would for a diagnostic AI device. The tests themselves are designed to measure against these established benchmarks.
4. Adjudication Method for the Test Set:
- This information is not applicable. Since the "ground truth" is based on objective standards and measurement rather than expert interpretation of complex data (like medical images), there is no need for an adjudication method among experts.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study assesses reader performance with and without AI assistance for diagnostic tasks. The Straumann® Variobase® Abutments are a physical implant component, not a diagnostic AI device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No, this is not applicable. The device is a physical medical component, not an AI algorithm. While software validation was performed, it relates to the design and manufacturing software, not a standalone AI diagnostic tool.
7. The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria is based on established regulatory standards, consensus standards (ISO), and FDA guidance quantitative limits and requirements. For example:
- Material: ISO 5832-11 for titanium alloys.
- Dynamic Fatigue: FDA guidance document for Class II Endosseous Dental Implants and Abutments, which sets performance thresholds.
- Biocompatibility (Cytotoxicity, Extractables): ISO 10993 series standards.
- Sterilization: ISO 17665 series standards and FDA guidance.
- Software: FDA guidance and IEC 62304.
8. The Sample Size for the Training Set:
- This information is not applicable. This submission is for a physical medical device, not a machine learning model that requires a training set. The term "training set" is relevant for AI/ML device development.
9. How the Ground Truth for the Training Set Was Established:
- This information is not applicable for the same reasons as point 8.
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Image /page/0/Picture/2 description: The image is a circular logo for the U.S. Department of Health & Human Services. The outer ring of the logo contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". Inside the ring is a symbol consisting of three stylized human profiles facing to the right. The profiles are connected and appear to be layered on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 7, 2017
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA. LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K170356
Trade/Device Name: Straumann® Variobase® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8, 2017 Received: May 9, 2017
Dear Jennifer 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.
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
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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.
Lori A. Wiggins -S6
for
Tina Kiang, Ph.D. Acting 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)
Device Name
Straumann® Variobase® Abutments
Indications for Use (Describe)
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 screwretained 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | K170356 |
|---|---|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810 |
| Contact Person: | Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality+1 (978) 747-2509 |
| Prepared By &Secondary Contact: | Christopher KlaczykHead of Regulatory Affairs & ComplianceInstitut Straumann AG+41 61 965 1260 |
| Date Prepared: | June 01, 2017 |
| Product Code(s): | NHA (21 CFR 872.3630) |
| Device Class: | II (21 CFR 872.3630) |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Common Name | Endosseous dental implant abutment |
| Proprietary Name: | Straumann® Variobase® Abutments |
| Predicate Device(s): | K142890, Straumann Variobase Abutments (InstitutStraumann) |
| Reference Device(s): | K050160, Katana Zirconia (Noritake Company)K131534, KATANA Zirconia (Kuraray Noritake Dental)K143439, KATANA Zirconia (Kuraray Noritake Dental)K120822, CARES Variobase Abutments (Institut Straumann)K151324, Variobase for CEREC (Institut Straumann) |
| Device Description: | The purpose of the subject submission is to add the zerion® MLand zerion® UTML Zirconia ceramic materials as a materialsuitable for fabrication of the coping, crown or bridge that,when bonded to the previously cleared Variobase abutmentbase (K120822, K142890), forms a finished dental prosthesis. |
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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. The restoration will be manufactured via validated Straumann milling.
Image /page/4/Figure/2 description: The image shows a dental implant device. The device consists of a basal screw, a prosthetic restoration (full contour crown), and a Straumann Variobase Abutment. The image shows the device in two different views, one in cross-section and one in full view.
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.
Materials:
- · Straumann Variobase Abutments: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The Straumann® Variobase™ Abutments are identical to the Straumann predicates (K142890).
- Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw components of the Straumann® Variobase™ Abutments are identical to the basal screw components of the Straumann predicates (K142890).
- · Coping, Crown or Bridge: zerion® ML Zirconia and zerion® UTML Zirconia ceramic materials.
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| TechnologicalCharacteristics: | A comparison of the relevant technological characteristicsbetween the subject and primary predicate devices is providedin the table that follows. |
|---|---|
| Performance Data: | The material used in the manufacture of Straumann VariobaseAbutments is a titanium-aluminum-niobium alloy which meetsthe requirements of ISO 5832-11. Bench testing was performedto evaluate the performance of the proposed Straumann®Variobase™ Abutments.• Dynamic fatigue tests were conducted in according to theFDA guidance document “Guidance for Industry and FDAStaff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous DentalAbutments”.• Steam sterilization validation per FDA guidance entitledReprocessing Medical Devices in Health Care Settings:Validation Methods and Labeling dated March 17, 2015 andthe ISO 17665 series standards.• Cytotoxicity per ISO 10993-5• Inorganic extractables/leachables per ISO 10993-18• Software validation per FDA guidance document: GeneralPrinciples of Software Validation; Final Guidance forIndustry and FDA Staff, issued on: January 11, 2002 and perIEC 62304.No animal or human clinical studies were conducted. |
| Conclusions: | Based upon our assessment of the design and applicableperformance data, the subject devices have been determined tobe substantially equivalent to the identified predicate devices. |
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| Feature | SUBJECT DevicesStraumann Variobase Abutments | Primary PREDICATE DeviceStraumann Variobase Abutments(K142890) | Equivalence Discussion |
|---|---|---|---|
| Indications forUse | The Straumann® Variobase™ Abutment is atitanium base placed onto Straumann dentalimplants to provide support for customizedprosthetic restorations. Straumann®Variobase™ Abutments are indicated forscrew-retained single tooth or cement-retained single tooth and bridgerestorations. | The Straumann® Variobase™ Abutment is atitanium base placed onto Straumann dentalimplants to provide support for customizedprosthetic restorations. Straumann®Variobase™ Abutments are indicated forscrew-retained single tooth or cement-retained single tooth and bridgerestorations. | Identical |
| Ti-baseMaterial | Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb) | Identical |
| AbutmentDiameter | 3.8 - 7.0 mm | 3.8 – 7.0 mm | Identical |
| Abutment Height | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Identical |
| Max. Angulation | 30° | 30° | Identical |
| Coping/ CrownMaterial | zerion® ML zirconia ceramic and zerion®UTML zirconia ceramic are being added tothe previously cleared coping/crownmaterials | Traditional Workflow:Type 4 Metals (ISO 22674)IPS e.max® Press CeramicDigital Workflow:polycon® ae (temporary)zerion® (permanent)IPS e.max® CAD Ceramic (permanent)coron® (permanent) | EquivalentThe digital workflow is being expanded toadd additional materials, zerion® ML &UTML zirconia ceramics.zerion® ML & UTML zirconia ceramics aresubstantially equivalent to the previouslycleared zerion® HT zirconia ceramics |
| Design Workflow | Wax-up or CAD | Wax-up or CAD | Identical |
| Feature | SUBJECT DevicesStraumann Variobase Abutments | Primary PREDICATE DeviceStraumann Variobase Abutments(K142890) | Equivalence Discussion |
| ManufacturingWorkflow | Straumann Milling | Traditional casting or pressingorStraumann Milling | Identical |
| Mode ofAttachment | Screw-retained or cement retained | Screw-retained or cement retained | Identical |
| Reusable | No | No | Identical |
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§ 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.)