(151 days)
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).
There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.
The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.
There are three components to the Straumann® Variobase® for Crown AS:
- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw
Here's an analysis of the provided text regarding the Straumann® Variobase® for Crown AS, focusing on acceptance criteria and the study proving it meets those criteria.
1. Table of Acceptance Criteria and Reported Device Performance
The provided FDA 510(k) summary does not explicitly state numerical acceptance criteria in the typical sense (e.g., "device must perform at X% accuracy"). Instead, it focuses on demonstrating substantial equivalence to predicate devices through various performance tests and material comparisons. The "acceptance criteria" can be inferred as successful completion of the listed tests and demonstrating comparable performance or safety profiles to the predicates.
| Acceptance Criteria (Inferred from testing) | Reported Device Performance (Summary from submission) |
|---|---|
| Dynamic Fatigue Performance (conforming to FDA guidance and ISO 14801) | Met: Dynamic fatigue testing was conducted, and the device (both subject and listed materials) demonstrated performance comparable to or exceeding predicate devices. The study results are deemed "satisfactorily addressed" via bench studies. |
| Software Validation (conforming to IEC 62304) | Met: Software validation was conducted. |
| Sterilization Validation (conforming to ISO 17665-1 and ISO/TS 17665-2) | Met: Sterilization validation was conducted for various materials, including those for the subject device and predicates. |
| Biocompatibility Testing | Met: Biocompatibility testing was conducted for various materials, including the subject device and predicates. |
| Material Equivalence (Ti-6Al-7Nb alloy for TiBase) | Met: Identical Ti-6Al-7Nb alloy used for both subject and predicate devices. |
| Dimensional Equivalence (Abutment Diameter) | Met: Identical abutment diameters (3.8 mm – 7.0 mm) for subject and predicate devices. |
| Functional Equivalence (Mode of Attachment) | Met: Identical screw-retained or cement-retained attachment for subject and predicate devices. |
| Manufacturing Workflow Equivalence | Met: Both traditional casting/pressing and Straumann Milling workflows are supported, identical to predicate where applicable. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide details on the specific sample sizes for the test sets (e.g., number of units tested for fatigue, number of software test cases). It broadly states that "bench studies" were conducted.
- Sample Size: Not explicitly stated for performance tests.
- Data Provenance: The studies were internal "bench studies" conducted by Institut Straumann AG. The country of origin of the data is not specified, but the applicant is Institut Straumann AG (Switzerland), with a US contact address. The studies appear to be prospective as they were conducted to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable in this context. The device is a physical dental implant component, not an AI/software device requiring expert interpretation for "ground truth" establishment of medical images or patient data. The "ground truth" for performance is based on established engineering standards (ISO, FDA guidance) and validated testing methods.
4. Adjudication Method for the Test Set
This is not applicable. As a physical device undergoing performance and material testing, there is no need for an adjudication method as would be relevant for clinical studies or AI diagnostic tools involving human interpretation.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted and is not applicable for this type of device. An MRMC study is typically used for diagnostic devices (e.g., AI in radiology) where the performance of human readers with and without AI assistance is being evaluated. This device is a dental implant abutment, not a diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone algorithm performance study was not conducted and is not applicable. This is a physical medical device, not a standalone algorithm. Its function is to be physically implanted and support dental restorations. While it supports digitally designed copings, the device itself is not a software algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering standards, material science properties, and validated test methods. Specifically:
- Dynamic fatigue testing: Conformance to ISO 14801 and FDA guidance. This standard dictates how fatigue life is measured and evaluated.
- Software validation: Conformance to IEC 62304 for medical device software lifecycle processes.
- Sterilization validation: Conformance to ISO 17665-1 and ISO/TS 17665-2.
- Biocompatibility: Likely conformance to ISO 10993 series.
- Material specifications: Ti-6Al-7Nb alloy properties.
These standards and specifications define the "truth" against which the device's physical and functional performance is measured.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical component. It does not employ machine learning or AI that requires a "training set" of data in the conventional sense. The "training" for this device involves its design, engineering, and manufacturing process based on established dental implant principles.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the same reasons as #8. There is no training set or ground truth in the context of machine learning for this device. The design and validation are based on engineering principles and regulatory standards.
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.
March 30, 2018
Institut Straumann AG % Jennifer Jackson Director of Regulatory Affairs and Quality Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810
Re: K173379
Trade/Device Name: Straumann® Variobase® for Crown AS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 2, 2018 Received: March 5, 2018
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.
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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Andrew I. Steen -S
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K173379
Device Name
Straumann® Variobase® for Crown AS
Indications for Use (Describe)
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
Type of Use (Select one or both, as applicable)
図 Prescription Use (Part 21 CFR 801 Subpart D) 801 Subpart C)
□ Over-The-Counter Use (21 CFR
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FORM FDA 3881 (8/14) Equivalent
Page 1 of 1
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K173379 510(k) Summary
Submitter's Contact Information 1.1
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810 | ||
|---|---|---|---|
| Contact Person: | Jennifer M. Jackson, MSDirector, Regulatory Affairs and QualityTel +1 (978) 747 2509Fax +1 (978) 747 0023 | ||
| Prepared By: | Dr. Gordon DoddsManager Design Control QMEtkon GmbH | ||
| Date Prepared: | March 26, 2018 | ||
| Product Code(s): | NHA (§872.3630) | ||
| Device Class: | II (§872.3630) | ||
| Classification Panel: | Dental | ||
| 1.2 Name of the Device | |||
| Classification Name: | Endosseous dental implant abutment (§872.3630) | ||
| Proprietary Name: | Straumann® Variobase® for Crown AS | ||
| 1.3 Predicate Device(s) | |||
| Predicate Device(s): | • K142890 – Straumann Variobase Abutments | ||
| Reference Device(s): | • K120822 – Straumann CARES Variobase Abutments• K170354 – Straumann Variobase Abutments• K170356 - Straumann Variobase Abutments |
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1.4 Device Description
The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).
There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.
The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.
There are three components to the Straumann® Variobase® for Crown AS:
- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw
Image /page/4/Picture/9 description: The image shows a dental implant with several labeled components. The "Basal screw" is at the top, followed by the "Prosthetic restoration (full contour crown)". Below that is the "Straumann® Variobase AS Ti-base", which connects to the implant itself. The implant is a cylindrical, screw-like structure designed to be embedded in the jawbone.
Figure 1 – Two-piece abutment consisting of a Straumann® Variobase® for Crown AS and a milled coping
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The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:
- Cast materials: ●
- Type 4 metals (ISO 22674) O
- o Base metal alloys (e.g., cobalt-chromium (CoCr))
- o Noble metal alloys (e.g., gold alloy)
- Press materials:
- o IPS e.max® Press Ceramic
- Digital materials: ●
- coron® O
- zerion® LT O
- polycon® ae O
- zerion ML O
- zerion UTML O
- IPS e.max® CAD Ceramic O
- O n!ce
1.5 Intended Use
Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.
1.6 Indications for Use
The Straumann® Variobase® for Crown AS is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® for Crown AS are indicated for screw retained single tooth or cement-retained single tooth and bridge restorations. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. Temporary restorations are indicated to be placed out of occlusion. All digitally designed copings and/or crowns for use with the Straumann Variobase® for Crown AS are intended to be sent to Straumann for manufacture at a validated milling center.
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1.7 Technological Characteristics
The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table.
| Feature | SUBJECTStraumann® Variobase® forCrown AS | PREDICATEK142890, StraumannVariobase Abutments | REFERENCEK120822 Straumann CARESVariobase Abutment | EquivalenceDiscussion |
|---|---|---|---|---|
| Indications forUse | The Straumann® Variobase® forCrown AS is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. Straumann®Variobase® for Crown AS areindicated for screw retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations. A temporaryrestoration can be used prior tothe insertion of the finalcomponents to maintain,stabilize and form the soft tissueduring the healing phase.Temporary restorations areindicated to be placed out ofocclusion. All digitally designedcopings and/or crowns for usewith the Straumann® Variobase®for Crown AS are intended to besent to Straumann formanufacture at a validatedmilling center. | The Straumann® Variobase™Abutment is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. Straumann®Variobase™ Abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations. All digitallydesigned copings and/orcrowns for use with theStraumann VariobaseAbutment system are intendedto be sent to Straumann formanufacture at a validatedmilling center. | The Straumann® Variobase™Abutment is a titanium baseplaced onto Straumann dentalimplants to provide support forcustomized prostheticrestorations. Straumann®Variobase™ Abutments areindicated for screw-retainedsingle tooth or cement-retainedsingle tooth and bridgerestorations. | IdenticalTemporary materialscrowns (Polycon AE) areused with the subjectand predicate devices.The subject devicesinclude advice to ensurethat temporaryrestorations are placedout of occlusion in orderto assist with implantstabilization.Updates to the predicatedevice IFUs, made since510(k) clearance, giveidentical advice as thesubject device. |
| TiBaseMaterial | Titanium-Aluminum-Niobiumalloy(Ti-6Al-7Nb) | Titanium-Aluminum-Niobiumalloy(Ti-6Al-7Nb) | Titanium-Aluminum-Niobiumalloy(Ti-6Al-7Nb) | Identical |
| Table 1 - Device Substantial Equivalence Comparison - Straumann® Variobase® for Crown AS |
|---|
| ------------------------------------------------------------------------------------------ |
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| Feature | SUBJECTStraumann® Variobase® forCrown AS | PREDICATEK142890, StraumannVariobase Abutments | REFERENCEK120822 Straumann CARESVariobase Abutment | EquivalenceDiscussion |
|---|---|---|---|---|
| AbutmentDiameter | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | Identical |
| Prosthetic Height(Abutment PostHeight) | 3.5 mm – 6.5 mm | 3.5 mm - 4.5 mm | 3.5 mm – 4.5 mm | EquivalentThe option for additionalheight of the apical partof the TiBase inStraumann® Variobase®for Crown AS providesfor a larger area ofretentive cement andmaterial for resistingforce. |
| Mode ofAttachment | Screw-retained or cementretained | Screw-retained or cementretained | Screw-retained or cementretained | Identical |
| Basal Screws | TAN Basal screws for NC/RC,NNC. RN/WN interfaces with awider screwhead (~10% wider) ,to allow for up to 25° ofangulation with respect to theVariobase AS axis with anangled screwdriver. Screws aremarked with a green ring so theycan be identified. | TAN Basal screws for NC/RC,NNC, RN/WN interfaces, withlimited angled entry ofscrewdriver. | TAN Basal screws for NC/RC,NNC, RN/WN interfaces, withlimited angled entry ofscrewdriver. | EquivalentA wider screw headpermits the angulation.The cone below thescrewhead is slightlylonger to make thescrew head wider. Thescrews have the sameoverall length, |
| Reusable | No | No | No | Identical |
| Source of InputFiles for CrownDesign | Intra-Oral ScannersBench-top Scanners | Intra-Oral ScannersBench-top scanners | Intra-Oral ScannersBench-top scanners | Identical |
| DesignEnvironment | Straumann CARES Visual:Closed CAD System facilitatingthe design of tooth-bornerestorations and restorationsused in conjunction with thedevices of the Straumann DentalImplant System (SDIS). | Straumann CARES Visual:Closed CAD System facilitatingthe design of tooth-bornerestorations and restorationsused in conjunction with thedevices of the Straumann DentalImplant System (SDIS). | Straumann CARES Visual:Closed CAD System facilitatingthe design of tooth-bornerestorations and restorationsused in conjunction with thedevices of the Straumann DentalImplant System (SDIS). | Identical |
| Feature | SUBJECTStraumann® Variobase® forCrown AS | PREDICATEK142890, StraumannVariobase Abutments | REFERENCEK120822 Straumann CARESVariobase Abutment | EquivalenceDiscussion |
| RestorationTypes Supported | Patient-specific copings andcrowns for Variobase for CrownAS | Patient-specific copings andcrowns for Variobase for Crown | Patient-specific copings andcrowns for Variobase for Crown | Equivalent |
| SupportedRestorativeMaterials | Traditional Workflow:Type 4 Metals (ISO 22674)IPS e.max® Press CeramicDigital Workflow:IPS e.max® CAD Ceramic(permanent)coron® (permanent)zerion® (permanent)polycon® ae (temporary)zerion MLzerion UTMLn!ce | Traditional Workflow:Type 4 Metals (ISO 22674)IPS e.max® Press CeramicDigital Workflow:IPS e.max® CAD Ceramic(permanent)coron® (permanent) | Digital Workflow:polycon® ae (temporary)zerion® (permanent) | Identical |
| FabricationWorkflow | Traditional casting or pressingorStraumann Milling | Traditional casting or pressingorStraumann Milling | Straumann Milling | Identical |
| Reusable | No | No | No | Identical |
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1.8 Performance Testing
Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies.
The following testing has been conducted:
- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- Software validation conforming to the requirements of IEC 62304. ●
- o Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
| Variobasematerials | Fatigue tests -predicates | Sterilizationvalidationpredicates | Biocompatibilitytesting -predicates |
|---|---|---|---|
| coron® | K142890 | K142890 | K142890 |
| zerion® LT | Subject device | Subject device | K120822 |
| polycon® ae | K142890 | K120822 | K142890 |
| zerion ML/ zerionUTML | K170356 | K170356 | K170356 |
| n!ce | K170354 | K170354 | K170354 |
| IPS e.max CAD | K142890 | K142890 | K142890 |
●
1.9 Conclusion
Based upon our assessment of the design and applicable performance data, the subject devices have been determined to be substantially equivalent to the identified predicate devices.
§ 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.)