Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. 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. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

Device Description

The Straumann Variobase Abutments for Bars & Bridges are non-engaging abutments made from Ti-6Al-7Nb (TAN) that support a bridge or bar reconstruction (framework or full contour) on two or more dental implants. The corresponding basal screw is delivered with the abutment for connecting the abutment to the implant. A dental laboratory technician designs and manufactures the bridge/bar reconstruction via their preferred workflow using traditional or CAD/CAM methods.

AI/ML Overview

The provided text is a 510(k) Summary for the Straumann® Variobase® Abutment for Bridges/Bars. It outlines the characteristics of the device and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a specific study proving the device meets those criteria in the typical sense of a diagnostic or clinical performance study.

Instead, the "study" referred to is a bench study focused on mechanical performance and material characteristics to demonstrate substantial equivalence to legally marketed predicate devices, rather than a clinical study evaluating diagnostic accuracy or effectiveness.

Here's a breakdown of the requested information based on the provided text, highlighting what is available and what is not:

1. A table of acceptance criteria and the reported device performance

The document doesn't present explicit "acceptance criteria" in a quantitative, pass/fail table for clinical performance. Instead, it discusses "equivalence" based on various features and a dynamic fatigue test.

Feature/Characteristic	Acceptance Criteria (Implied by Equivalence)	Reported Device Performance
Indications for Use	Within the scope of the predicate devices.	"The basic indication of providing support for prostheses is identical. Where the predicate is indicated for both single-unit and multi-unit restorations, the subject devices are only suitable for multi-unit restorations. This limited indication is within the scope of the indication of the predicate devices." (Equivalent)
Abutment Material	Identical to predicate device material (Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)).	"Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb)" (Identical)
Abutment Diameter	Within the range of predicate device diameters.	"Subject device diameters are within the range of diameters for the predicate device." (Subject: 4.2 - 7.0 mm, Predicate: 3.8 - 7.0 mm) (Equivalent)
Abutment Height	Same minimum height as predicate; taller variants' performance addressed via bench testing.	"The subject devices have the same minimum height as the Variobase predicates. Performance of the taller subject device is addressed via bench testing." (Subject: 3.5 – 5.2 mm, Predicate: 3.5 – 4.5 mm) (Equivalent)
Abutment Apical Design	Morse taper portion identical to predicate; non-engaging feature for multi-unit restorations.	"The Morse taper portion of both the subject and Variobase predicate devices are identical. Non-engaging abutments are necessary so as not to introduce mechanical constraints in the framework that would affect fit." (Equivalent)
Abutment Coronal Design	Conic taper within the range established by reference predicates.	"The conic taper of the subject devices is within the range established by the synOcta and Multibase predicates." (Equivalent)
Restoration Material	Within the scope of materials indicated for the predicate devices.	"The range of materials cleared for use with the predicate devices is within the scope of materials indicated for the subject devices." (Equivalent)
Design/Manufacturing Workflow	Identical to predicate.	"Identical"
Mode of Attachment	Identical to predicate (Screw-retained or cement retained).	"Identical"
Reusable	Identical to predicate (No).	"Identical"
Dynamic Fatigue	Satisfactorily addressed via bench studies and consistent with FDA guidance and ISO 14801. (Implied: Device must meet or exceed performance of predicate or relevant standards.)	"Dynamic fatigue test data consistent with FDA guidance and ISO 14801 have been referenced in support of this submission." This indicates the device passed these structural integrity tests relevant to dental implants and abutments.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily relies on bench testing for dynamic fatigue. It doesn't specify a sample size for this testing other than "data have been referenced." No information is provided about data provenance ( країни of origin or retrospective/prospective nature) as it's not a clinical data study.

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)

This information is not applicable here because the "test set" refers to physical samples for mechanical testing (dynamic fatigue), not a dataset for a diagnostic algorithm where expert ground truth would be established.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable. Adjudication methods are typically used for establishing ground truth in clinical or image-based studies, not for mechanical 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

This is not applicable. The device is an endosseous dental implant abutment, a physical component, not an AI or diagnostic tool. Therefore, MRMC studies and AI assistance comparisons are irrelevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable as the device is a physical medical device, not a software algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" in this context is the mechanical performance standards (e.g., ISO 14801 for dynamic fatigue) and the material properties of the device, which are evaluated through bench testing. There is no biological or diagnostic "ground truth" from human subjects involved in this 510(k) submission for mechanical equivalence.

8. The sample size for the training set

This is not applicable. There is no "training set" as this is not a machine learning or AI-based device.

9. How the ground truth for the training set was established

This is not applicable for the same reason as point 8.

Summary

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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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, but instead of snakes, it features three abstract human profiles facing right.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 5, 2015

Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810

Re: K151157

Trade/Device Name: Straumann® Variobase® Abutment for Bars/bridges Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 2, 2015 Received: July 6, 2015

Dear Mr. Klaczyk:

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 (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,

Tina
Kiang-S

for 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

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Indications for Use

510(k) Number (if known) K151157

Device Name

Straumann® Variobase Abutments for Bridges/Bars

Indications for Use (Describe)

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)

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K151157

510(k) Summary

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315Owner/Operator No.: 9005052
Contact Person:	Christopher KlaczykDirector of Regulatory Affairs and Clinical Research
Date Prepared:	August 4, 2015
Product Code(s):	NHA (21 CFR 872.3630)
Device Class:	II(21 CFR 872.3630)
Classification Panel:	Dental
Classification Name:	Endosseous dental abutment (21 CFR 872.3630)
Proprietary Name:	Straumann® Variobase® Abutment for Bridges/Bars
Predicate Device(s):	• K142890, Straumann Variobase Abutments
Reference Device(s):	• K132219, Straumann Variobase Abutments• K120822, Straumann CARES Variobase Abutment NNC,RN, WN, NC, RC• K080239, Straumann Bone Level Multibase Abutments• K990342, Straumann synOcta Prosthetics• K140737, Straumann Screw-Retained Bridge and Bar
Device Description:	The Straumann Variobase Abutments for Bars & Bridges arenon-engaging abutments made from Ti-6Al-7Nb (TAN) thatsupport a bridge or bar reconstruction (framework or fullcontour) on two or more dental implants. The correspondingbasal screw is delivered with the abutment for connecting theabutment to the implant. A dental laboratory technician designsand manufactures the bridge/bar reconstruction via theirpreferred workflow using traditional or CAD/CAM methods.

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Indications For Use:	Straumann® Variobase® prosthetic components directlyconnected to the endosseous dental implants are indicated foruse as an aid in prosthetic rehabilitations. The prostheticrestoration (bridge or overdenture) can be cemented on theStraumann® Variobase® prosthetic components. A temporaryrestoration can be used prior to the insertion of the finalcomponents to maintain, stabilize and form the soft tissueduring the healing phase. They may not be placed intoocclusion. Final abutments and restorations may be placed intoocclusion when the implant is fully osseointegrated.
Intended Use:	Straumann® Variobase® abutments are intended to be placedinto Straumann dental implants to provide support for prostheticreconstructions such as bridges and over-dentures.
Materials:	The subject devices are produced from titanium-6aluminum-7niobium alloy (TAN). This is the same material as for thepredicate devices cleared to market per premarket notificationsubmissions K120822, K132219 and K142890.
TechnologicalCharacteristics:	The subject Straumann Variobase Abutments for Bridge/Bardevices have the same Indications For Use, Implant-to-Abutment platforms, materials, packaging and dynamic fatigueperformance as the identified Straumann Variobase Abutmentpredicate devices.
	The subject devices differ in that they do not include theengaging features of the implant-to-abutment interface designallowing full axial rotation and the coronal aspect takes a formbetter suited to multi-unit restorations.

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FEATURE	Straumann® Variobase®Abutments for Bridges/BarsSubject Submission	Primary PredicateStraumann® Variobase®Abutments(K142890)	Reference DevicesStraumann® Multibase(K080239) and synOcta(K990342) Abutments	EquivalenceDiscussion
Indications forUse	Straumann® Variobase®prosthetic components directlyconnected to the endosseousdental implants are indicated foruse as an aid in prostheticrehabilitations. The prostheticrestoration (bridge or over-denture) can be cemented on theStraumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and form the soft tissueduring the healing phase. Theymay not be placed intoocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated.	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.	Not applicable	EquivalentThe basic indication ofproviding support for prosthesesis identical. Where the predicateis indicated for both single-unitand multi-unit restorations, thesubject devices are only suitablefor multi-unit restorations. Thislimited indication is within thescope of the indication of thepredicate devices.
AbutmentMaterial	Titanium-Aluminum-Niobiumalloy (Ti-6Al-7Nb)	Titanium-Aluminum-Niobiumalloy (Ti-6Al-7Nb)	Not applicable	Identical
AbutmentDiameter	4.2 - 7.0 mm	3.8 - 7.0 mm	Not applicable	EquivalentSubject device diameters arewithin the range of diameters forthe predicate device.
FEATURE	Straumann® Variobase®Abutments for Bridges/BarsSubject Submission	Primary PredicateStraumann® Variobase®Abutments(K142890)	Reference DevicesStraumann® Multibase(K080239) and synOcta(K990342) Abutments	EquivalenceDiscussion
AbutmentHeight	3.5 – 5.2 mm	3.5 – 4.5 mm	Not applicable	EquivalentThe subject devices have thesame minimum height as theVariobase predicates.Performance of the taller subjectdevice is addressed via benchtesting.
AbutmentApicalDesign	Non-engaging Morse taper	Engaging CrossFit® and Morsetaper	Not applicable	EquivalentThe Morse taper portion of boththe subject and Variobasepredicate devices are identical.Non-engaging abutments arenecessary so as not to introducemechanical constraints in theframework that would affect fit.
AbutmentCoronalDesign	10° or15° conical taper	Straight wall with detents	6° conical taper (K990342)30° conical taper (K080239)	EquivalentThe conic taper of the subjectdevices is within the rangeestablished by the synOcta andMultibase predicates.
FEATURE	Straumann® Variobase®Abutments for Bridges/BarsSubject Submission	Primary PredicateStraumann® Variobase®Abutments(K142890)	Reference DevicesStraumann® Multibase(K080239) and synOcta(K990342) Abutments	EquivalenceDiscussion
RestorationMaterial	Materials cleared by the FDAunder 21 CFR 872.6660 orexempt materials as describedunder 21 CFR 872.3060 (Noblemetal alloys) and 21 CFR872.3710 (Base metal alloys)	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)	Not applicable	EquivalentThe range of materials clearedfor use with the predicatedevices is within the scope ofmaterials indicated for thesubject devices.
DesignWorkflow	Wax-up or Open CADExempt from pre-marketnotification according to 21CFR 807.85(a)(1).	Wax-up or Open CAD	Not applicable	Identical
ManufacturingWorkflow	Traditional casting, pressing orStraumann Milling CenterExempt from pre-marketnotification according to 21CFR 807.85(a)(1).	Traditional casting, pressing orStraumann Milling Center	Not applicable	Identical
Mode ofAttachment	Screw-retained or cementretained	Screw-retained or cementretained	Not applicable	Identical
Reusable	No	No	Not applicable	Identical

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Discussion ofSubstantialEquivalence:	The basic indication of providing support for prostheses isidentical. Where the predicate is indicated for both single-unitand multi-unit restorations, the subject devices are onlysuitable for multi-unit restorations. This limited indication iswithin the scope of the indication of the predicate devices.Subject device diameters are within the range of diameters forthe predicate devices. The subject devices have the sameminimum height as the Variobase predicates.
	Performance of the taller subject device is addressed via benchtesting. The Morse taper portion of both the subject andVariobase predicate devices are identical. Non-engagingabutments are necessary so as not to introduce mechanicalconstraints in the framework that would affect fit. The conictaper of the subject devices is within the range established bythe synOcta and Multibase predicates. The bonding surfaceareas for the subject devices are consistent with those of thepredicate. The range of materials cleared for use with thepredicate devices is within the scope of materials indicated forthe subject devices.
Performance Data:	Per Guidance for Industry and FDA Staff - Class II SpecialControls Guidance Document: Root-form Endosseous DentalImplants and Endosseous Dental Abutments dated May 12,2004, the substantial equivalence of the subject device(s) aresatisfactorily addressed via bench studies. Dynamic fatigue testdata consistent with FDA guidance and ISO 14801 have beenreferenced in support of this submission.
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.

Regulation Number and Section

§ 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.)