Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. 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.

Device Description

BLX Variobase abutments are two-piece abutments composed of the following components: Variobase™ Abutment (Ti-base), Prosthetic restoration (coping or crown), Basal Screw. The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center. The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw. The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw. The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment). The BLX Variobase abutments are cleared under K173961. The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Straumann® BLX Variobase Abutment, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria (Implicit)	Reported Device Performance
Sterilization Process	Validation according to FDA guidance "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling" and ISO 17655-1.	Sterilization process for BLX Variobase Abutments was validated according to applicable recommendations in FDA guidance and ISO 17655-1.
Biocompatibility	Evaluation according to ISO 10993-1:2009 and FDA Guidance "Use of International Standard ISO 10993-1". No new issues of biocompatibility raised.	Biocompatibility was evaluated according to ISO 10993-1:2009 and FDA Guidance. No new issues of biocompatibility were raised, and therefore, no additional biocompatibility testing was required.
Dynamic Fatigue (Implant-Abutment System)	Dynamic loading test for endosseous dental implants according to FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and ISO 14801. Performance equivalent to predicate and reference devices.	Test results demonstrated the Straumann® BLX Implant/Variobase final abutment system is equivalent to the predicate and reference devices. Test environment: 0.9% NaCl at 37°C.
Substantial Equivalence	Demonstration of substantial equivalence to primary predicate and reference devices.	The documentation demonstrated the BLX Variobase Abutments are substantially equivalent to the primary predicate and reference devices.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not explicitly state sample sizes for specific 'test sets' in the way one might expect for a clinical trial or AI model evaluation. However, for the bench testing:

Dynamic Fatigue Test: The text implies a sufficient number of samples were tested to demonstrate equivalence according to ISO 14801 and the FDA guidance. No specific number is given.
Data Provenance: The studies were conducted as part of the device manufacturer's (Institut Straumann AG) regulatory submission to the FDA, suggesting a controlled internal testing environment. The country of origin for the data is implied to be related to the manufacturer's R&D facilities. This is a prospective set of tests conducted to support the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable to this type of device submission. The Straumann® BLX Variobase Abutment is a medical device, and its acceptance criteria are based on engineering performance specifications, material science, and regulatory compliance (e.g., sterilization efficacy, biocompatibility, mechanical strength), not on interpretation of images or patient data by experts. Therefore, "ground truth" in the clinical sense (e.g., diagnosis by radiologists) is not relevant here.

4. Adjudication Method for the Test Set

This is not applicable as the evaluation involves bench testing and adherence to standards, not human adjudication of a clinical outcome.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This is not applicable. An MRMC study is relevant for diagnostic imaging devices where human readers interpret medical images. This device is an endosseous dental implant abutment, which is a prosthetic component.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

This is not applicable. This device is a physical medical component, not an algorithm. Bench tests evaluate the standalone performance of the physical device under simulated conditions.

7. Type of Ground Truth Used

The "ground truth" for this device's performance evaluation is established through:

Established Standards: Adherence to international standards like ISO 14801 (dynamic loading) and ISO 10993-1 (biocompatibility), and ISO 17655-1 (sterilization).
Regulatory Guidance: Compliance with specific FDA guidance documents for root-form endosseous dental implants and abutments.
Material Specifications: Properties of the materials used (Ti-6Al-7Nb) meet established strength and biocompatibility profiles.
Functional Equivalence: Demonstration that the new device performs equivalently to previously cleared predicate devices under defined test conditions.

8. Sample Size for the Training Set

This is not applicable. There is no "training set" in the context of this device. It is a physical product, not an AI model requiring data training.

9. How the Ground Truth for the Training Set Was Established

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

Summary

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Indications for Use

510(k) Number (if known) K190082

Device Name Straumann® BLX Variobase Abutment

Indications for Use (Describe)

Straumann® Variobase® prosthetic components directly or indirectly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The prosthetic restoration (crowns) can be cemented onto the Straumann® Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must be placed out of occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® 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

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Subpart C)

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Straumann®BLX Variobase Abutment

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

Prepared by: Viviana Horhoiu

Date of Submission: April 16, 2019

5.2 Name of the Device

Trade Names:	Straumann® BLX Variobase Abutment
Common Name:	Endosseous Dental Implant Abutment
Classification Name:	Endosseous Dental Implant Abutment
Regulation Number:	21 CFR 872.3630
Classification:	Class II
Product Codes:	NHA

5.3 Predicate Device(s)

Primary Predicate Device:

. K173961 – Straumann BLX Implant System
Reference Devices:
K170356 Straumann Variobase Abutments .
K162890 Small Diameter Implant (SDI) ●
. K142890 – Straumann® Variobase Abutments

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Straumann®BLX Variobase Abutment

510(k) Summary

5.4 Device Description

BLX Variobase abutments are two-piece abutments composed of the following components:

. Variobase™ Abutment (Ti-base)
Prosthetic restoration (coping or crown) .
. Basal Screw

The BLX Variobase abutments are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The planning and milling of the customized restoration must be made using the validated Straumann CARES Visual, Dental Wings software using the Straumann CARES Visual Plug-In. All digitally designed copings and/or crowns for use on the Variobase abutments are intended to be manufactured at a validated milling center.

The BLX Variobase Abutments are manufactured from TAN (titanium-aluminum-niobium alloy) and are available in different gingiva heights and diameters. The abutments are delivered with the corresponding basal screw.

The prosthetic restoration (copings/crowns) can be cemented onto the Variobase abutment and then the set is screwed on the implant using the basal screw.

The BLX Variobase Abutments will be marketed as a stand-alone component or through the CARES® X-Stream™ workflow (prosthetic restoration designed and manufactured through CARES® Visual/validated Straumann milling and then shipped together with the Straumann® BLX Variobase® Abutment and basal screw in the same shipment).

The BLX Variobase abutments are cleared under K173961.

The purpose of this premarket notification is to extend the Straumann BLX Implant System portfolio with additional materials for customized restorations (upper part of the two-piece abutment) for use with the BLX Variobase abutments (lower part of the twopiece abutment).

Prosthetic Restoration Design and Materials

The following is an overview of the possible coping/crown materials:

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Straumann® BLX Variobase Abutment

510(k) Summary

Digital materials: .
- coron® (subject to this submission)
- o zerion® LT, ML or UTML (subject to this submission)
- IPS e.max CAD (cleared by K173961) o
- o polycon® ae (for temporary restorations, cleared by K173961)

The manufacturing of the coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use. The design of the digital coping and/or crown should follow the standard procedure according to the material manufacturer's instructions for use and Straumann's instructions for use.

Basal screws are used to fix the BLX Variobase Abutments to the dental implant, and can be also used during lab procedures to fix lab prosthetic parts on implant analogs. There is one basal screw for the RB platform and one for the WB platform. They have identical designs and differ only in color-coding (violet for RB and brown for WB) to ease the handling. They are provided along the abutments but they are also provided as standalone (replacement) screws. The BLX basal screws are manufactured from TAN.

5.5 Indications for Use

Technological Characteristics 5.6

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in Table 1.

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Straumann® BLX Variobase Abutment

510(k) Summary

	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE DEVICES
FEATURE	Straumann BLXVariobase Abutment	K173961Straumann BLXImplant System	K170356Straumann VariobaseAbutments	K162890Small Diameter Implant(SDI)	K142890Straumann® VariobaseAbutments
Indications forUse	Straumann® Variobase®prosthetic componentsdirectly or indirectlyconnected to theendosseous dental implantare intended for use as anaid in prostheticrehabilitations. Theprosthetic restoration(crowns) can be cementedonto the Straumann®Variobase® prostheticcomponents. A temporaryrestoration can be used priorto the insertion of the finalcomponents to maintain,stabilize and shape the softtissue during the healingphase; they must be placedout of occlusion. Finalabutments and restorationsmay be placed intoocclusion when the implantis fully osseointegrated. Alldigitally designed copingsand/or crowns for use withthe Straumann® Variobase®Abutment system areintended to be sent toStraumann for manufactureat a validated milling center.	Straumann® Variobase®prosthetic componentsdirectly or indirectlyconnected to theendosseous dental implantare intended for use as anaid in prostheticrehabilitations. Theprosthetic restoration(crowns) can be cementedonto the Straumann®Variobase® prostheticcomponents. A temporaryrestoration can be used priorto the insertion of the finalcomponents to maintain,stabilize and shape the softtissue during the healingphase; they must be placedout of occlusion. Finalabutments and restorationsmay be placed intoocclusion when the implantis fully osseointegrated. Alldigitally designed copingsand/or crowns for use withthe Straumann® Variobase®Abutment system areintended to be sent toStraumann for manufactureat a validated milling center.	The Straumann® Variobase®Abutment is a titanium baseplaced onto Straumanndental implants to providesupport for customizedprosthetic restorations.Straumann® Variobase®Abutments are indicated forscrew-retained single toothor cement-retained singletooth and bridgerestorations. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase®Abutment system areintended to be sent toStraumann for manufactureat a validated milling center.	Straumann® SC Variobase®abutments are indicated foruse as an aid in prostheticrehabilitations. Theprosthetic restoration can becemented on theStraumann® SC Variobase®prosthetic components. Atemporary restoration canbe used prior to the insertionof the final components tomaintain, stabilize and formthe soft tissue during thehealing phase. Finalabutments and restorationsmay be placed intoocclusion when the implantis fully osseointegrated. Alldigitally designed copingsand/or crowns for use withthe Straumann® Variobase®Abutment system areintended to be sent toStraumann for manufactureat a validated milling center.	The Straumann® Variobase®Abutment is a titanium baseplaced onto Straumanndental implants to providesupport for customizedprosthetic restorations.Straumann® Variobase®Abutments are indicated forscrew-retained single toothor cement-retained singletooth and bridgerestorations. All digitallydesigned copings and/orcrowns for use with theStraumann® Variobase®Abutment system areintended to be sent toStraumann for manufactureat a validated milling center.
Material	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-7Nb	Ti-6Al-7Nb
Implant toAbutmentConnection	BLX(with conical fitting)	BLX(with conical fitting)	CrossFit®	Small CrossFit® (SC)	CrossFit®synOcta® (RN/WN)
ProstheticPlatformDiameter	Ø 3.8 to 5.5 mm	Ø 3.8 to 5.5 mm	Ø 3.9 and 7.0 mm	Ø 3.3/4.3 mm(minor/major ovaldimension)	Ø 3.9 – 7.0 mm
	SUBJECT DEVICE	PRIMARY PREDICATE	REFERENCE DEVICES
FEATURE	Straumann BLXVariobase Abutment	K173961Straumann BLXImplant System	K170356Straumann VariobaseAbutments	K162890Small Diameter Implant(SDI)	K142890Straumann® VariobaseAbutments
Gingival Heights	0.75 - 3.5 mm	0.75 — 2.5 mm	1.0 - 3.0 mm	1.0 - 3.0 mm	1.0 - 3.0 mm
ChimneyHeights	5.5 mm(can be reduced)	5.5 mm(can be reduced)	3.5 - 4.5 mm	6.7 – 8.7 mm(overall height)	3.5 - 4.5 mm
Design Workflow	Wax-up or StraumannCARES® Visual, DentalWings software using theStraumann CARESVisual Plug-In and3Shape	Wax-up or StraumannCARES® Visual, DentalWings software using theStraumann CARESVisual Plug-In and3Shape	Wax-up or CAD	Wax-up or Open CADCARES® Visual	Wax-up or Open CAD
AbutmentAngulation	Up to 30°	Up to 30°	Up to 30°	Up to 30°	Up to 30°
ManufacturingWorkflow	Straumann Milling	Straumann Milling	Straumann Milling	Traditional casting orpressing or StraumannMilling	Traditional casting orpressing or StraumannMilling
Coping/ CrownMaterial	Digital materials:coron®zerion® LTzerion® ML and UTML	Digital materials:IPS e.max CADpolycon® ae	Digital materials:zerion® ML and UTML	Cast materials:Type 4 metals (ISO 22674)Base metal alloys (e.g.,cobalt-chromium (CoCr))Noble metal alloys (e.g.,gold alloy)Press materials:IPS e.max® Press CeramicDigital materials:coron®zerion® LTpolycon® ae	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)
SterilizationMethod	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized	Non-sterile/End user sterilized

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Straumann® BLX Variobase Abutment

510(k) Summary

Table 1 - Comparison of subject device versus reference devices (BLX Variobase Abutments)

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Straumann® BLX Variobase Abutment

510(k) Summary

5.7 Performance Testing

Sterilization and Shelf Life:

The sterilization process for the BLX Variobase Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015" and according to ISO 17655-1, Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices."

Biocompatibility:

Biocompatibility was evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for each of the subject devices. No new issues of biocompatibility are raised for the subject devices and therefore, no additional biocompatibility testing was required.

Performance Testing Bench:

Dynamic fatique tests for the implant-abutment system were conducted 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" and according to ISO 14801, "Dentistry -- Implants -- Dynamic loading test for endosseous dental implants". The test results demonstrated the Straumann® BLX Implant/Variobase final abutment system is equivalent to the predicate and reference devices. The test environment was 0.9% NaCl at 37°.

5.8 Conclusion

The documentation submitted in this premarket notification demonstrates the BLX Variobase Abutments are substantially equivalent to the primary predicate and reference devices.

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Image /page/7/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 17, 2019

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01810

Re: K190082

Trade/Device Name: Straumann® BLX Variobase Abutment Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: January 16, 2019 Received: January 17, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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Page 2

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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 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,

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

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.)