The Straumann CARES M-Series CAD/CAM System is indicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially or fully edentulous mandibles and maxillae. The system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

Device Description

The Straumann CARES M-Series CAD/CAM System is intended for the design and fabrication of dental restorations by dental laboratories by means of a digital workflow. The workflow is unchanged from the primary predicate K171649. This premarket notification is introducing the Straumann Variobase Abutments for the BLX implant to abutment interface to the previously cleared workflow.

The Straumann CARES M-Series CAD/CAM System employs optical impression files that document the topographical characteristics of teeth, traditional dental impressions, or stone models. The Straumann CARES Visual CAD software then allows the design of the desired restorations. The CAM software converts the digital restoration design into the tooling and tool path commands needed to fabricate the restoration. The CAM software also allows multiple restoration files to be combined (nested) in order to maximize the use of dental material blanks. The milling command file is encrypted prior to transfer to the M-Series mill; this encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. The user will load the milling command file into the M-Series mill where it is decoded. The user loads the appropriate dental material blank and initiates the milling operation.

This premarket notification includes restorations (copings, and bridges) manufactured from Zolid HT/Zolid SHT materials for cementation on Straumann Variobase Abutments for the BLX implant system. The BLX dental implant platforms include RB (Regular Base) and RB/WB (Regular Base/Wide Base). The combination of the coping, crown, or bridge and the Variobase Abutment component make up a two-piece abutment assembly, which is used in conjunction with endosseous dental implants for single or multiple tooth dental prostheses.

AI/ML Overview

Here's the information about 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

Feature/Test	Acceptance Criteria	Reported Device Performance
Dynamic Fatigue Test (Straumann BLX Variobase with Zolid SHT and Zolid HT crowns)	Demonstrated equivalence to the primary predicate and reference devices according to FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".	The tests demonstrated that the Straumann BLX Variobase with Zolid SHT and Zolid HT crowns are equivalent to the primary predicate and reference devices.
Milling System Validation	Confirmation that dimensions of milled restoration were the same as the intended CAD design from CARES Visual.	Leveraged from K171649, confirming the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced).
Simulated Use Validation	Confirmation of scan, design, and production capability of the subject devices in CARES Visual.	Leveraged from K171649, confirming the scan, design, and production capability of the subject devices in CARES Visual. (Subject devices were not considered a new worst case, so existing validation was referenced).
Sterilization Process Validation	Validation 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".	The sterilization process for the Straumann Variobase as recommended in the labeling was validated.

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

Specific sample sizes for the test set of the dynamic fatigue tests, milling system validation, and simulated use validation are not explicitly stated in the provided document.

The document mentions that the studies were "leveraged from K171649" (the primary predicate device) and that "the subject devices were not considered a new worst case." This implies that the validation data was likely historical or previously collected for the predicate device.

Regarding data provenance:

Country of Origin: Not specified.
Retrospective or Prospective: Not explicitly stated, but "leveraged from K171649" suggests a retrospective application of existing data and validation reports.

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

This information is not provided in the document. The studies mentioned are primarily engineering and performance tests (dynamic fatigue, dimensional accuracy, sterilization efficacy) and do not involve human expert interpretation of device output in a diagnostic or clinical context to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable as the studies described are performance and engineering validations, not studies involving human interpretation or clinical adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, an MRMC comparative effectiveness study involving human readers and AI assistance was not mentioned in the document. The device described is a CAD/CAM system for fabricating dental prosthetics, which is a manufacturing process, not an AI-powered diagnostic or interpretive tool that would typically be evaluated with MRMC studies.

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

The "Milling System Validation" and "Simulated Use Validation" could be considered forms of standalone performance evaluation for the CAD/CAM system's components (software outputs, milling accuracy).

Milling System Validation: Confirmed "the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual." This evaluates the algorithm's (CAD/CAM software's) ability to translate digital design into physical form, without human intervention in the final output quality check for the purpose of this specific validation.
Simulated Use Validation: Confirmed "the scan, design, and production capability of the subject devices in CARES Visual." This also assesses the system's performance in a simulated workflow.

The dynamic fatigue tests evaluate the physical product, not directly the algorithm's performance.

7. The Type of Ground Truth Used

Dynamic Fatigue Test: Ground truth is established by the specified FDA guidance document regarding performance requirements for dental implants and abutments. This involves objective physical testing against performance standards.
Milling System Validation: The "intended CAD design from CARES Visual" serves as the ground truth against which the milled restoration is compared for dimensional accuracy.
Simulated Use Validation: The expected functional capability of the system (scan, design, production) serves as the ground truth.
Sterilization Process Validation: The ground truth is adherence to the validated sterilization parameters and expected sterility assurance levels as defined by the FDA guidance document.

8. The Sample Size for the Training Set

This information is not provided in the document. The device is a CAD/CAM system, and while CAD/CAM software development might involve training (e.g., machine learning for design optimization or material properties), the submission focuses on validating the manufacturing process and the final product's performance, not the training of an AI model in the typical sense. The "training set" for the CAD/CAM system would implicitly be the engineering data and design principles embedded in the software.

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

As above, this information is not provided. If there were any AI/ML components in the CAD/CAM software that involved "training," the method for establishing ground truth for that training is not discussed. For the broader CAD/CAM system's engineering and design, the ground truth would typically be established through established engineering principles, material science, and preclinical testing to ensure precise and functional designs.

Summary

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and 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 is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K203456

Trade/Device Name: Straumann® CARES M-Series CAD/CAM System Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA, PNP Dated: June 7, 2021 Received: June 8, 2021

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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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

510(k) Number (if known) K203456

Device Name:

Straumann® CARES M-Series CAD/CAM System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable) 図Prescription Use (Part 21 CFR 801 Subpart D)

□Over-The-Counter Use (21 CFR 801 Subpart C)

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

Submitter's Contact Information

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810Registration No.: 1222315 Owner/Operator No.: 9005052
On behalf of:	Institut Straumann AGPeter Merian Weg, 12CH-4002 Basel, Switzerland
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and QualityPhone Number: +1-978-747-2509Fax Number: +1-978-747-0023
Prepared By &Alternate Contact:	Gordon DoddsManager Design Control QMEtkon GmbHPhone number: +49 89 30 90 75 291Fax number: +49 89 30 90 75 211
Date of Submission:	June 22, 2021

Name of the Device

Trade Names:	Straumann® CARES M-Series CAD/CAM System
Common Name:	Endosseous dental implant abutment
Classification Name:	Endosseous dental implant abutment
Regulation Number:	21 CFR 872.3630
Device Classification:	II
Product Code(s):	NHA, PNP
Classification Panel:	Dental

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

Predicate Device(s)

Primary Predicate:

. K171649 – Straumann® CARES M-Series CADCAM System
Reference Devices:
. K190040 – Straumann BLX Line Extension - New Abutments
K190082 Straumann® BLX Variobase® Abutment .
K 190662 MRI Compatibility for Existing Straumann Dental Implant Systems .

Device Description

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

The digital workflow using the Straumann CARES M-Series CAD/CAM System includes the use of the following products:

Dental Scanner(s)

The Straumann CARES M-Series CAD/CAM system can accept files generated using the following devices (note that these are not subject devices to this submission):

Dental Wings Intra-Oral Scanner, DWIO .
Dental Wings 3-Series & 7-Series desktop scanners (extra-oral) .
Straumann CARES CS2 scanner (extra-oral) .

The dental scanner takes optical impressions that document the topographical characteristics of teeth, traditional dental impressions, or stone models. This includes the location and orientation of dental implants or abutments when a Scanbody is employed during the scan.

CARES Visual CAD Software

The CARES Visual software is a dental CAD application that allows the user to digitally design dental restorations, based on information that was acquired by a dental scanner. As a result of the design process and the indication and material dependent dimensional limits, a threedimensional geometry is created that is linked to the selected restorative material/milling blank. The use of the Straumann manufacturer provided digital device models assures the accuracy of the interfaces between the designed restoration and the abutment or implant being restored.

CARES Visual CAM Module

The CAM interface module converts the three-dimensional geometry into milling machine control data. The CAM software uses the digital restoration geometry information and the material selection to define the tools to be used, the paths the tools are to follow to re-create the digital geometry in physical form and the speed and feed rates of the mill and the tooling. The CAM software also allows for multiple restoration files to fit within the geometry of a single dental material blank (a process referred to as nesting) in order to maximize the use of dental material blanks.

The completed CAM file is encrypted prior to being output for transfer to the milling machine. This encryption ensures that files generated using other CAD or CAM software cannot be used with the M-Series mill. This is a means of assuring that only the validated product configuration is used.

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

Straumann M-Series Milling Machine

The milling machine receives the CAM file from the CAM software. The user will load the CAM file into the M-Series mill where it is decoded. The user mounts the appropriate dental material blank, tools and burs. For certain materials the user will also employ a cutting fluid that acts as a lubricant and coolant for the milling operation. Once the machine is fully configured, the user initiates the milling operation.

Sintering Furnace

Straumann Therm ●
Some restoration materials are provided in a green (i.e. partially crystallized) state or are combined with a polymeric binder material. This is typically done to make the machining process easier and to increase tool life. These materials must undergo a sintering process affer milling in order to achieve their final form. This is carried out in a sintering furnace.

The milled geometries, in the materials that require sintering, are larger than the finished restoration to account for the shrinkage that will occur during sintering. This scaling is included in the CAD software as a material specific parameter. The CAD software will scale the digital restoration design using this parameter prior to transfer of the data to the CAM software in order to assure that the final, sintered restoration accurately reflects the digital design.

Restoration Material Milling Blanks

A selection of milling blanks is available for use with the Straumann CARES M-Series CAD/CAM system. The materials and their design control limits are identified in Table 1.

Material Name	Material	Minimum PostHeight (mm)	MaximumAngulation	Minimum WallThickness (mm)
Zolid HT	ZrO2	4.0	30°	0.6
Zolid SHT	ZrO2	4.0	30°	0.95
Zolid HT Preshade	ZrO2	4.0	30°	0.6

Table 1 – Materials with design control limits for use with Straumann BLX Variobase Abutments

Indications for Use

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

dentistry workflow: scan files from Intra-Oral Scanners or Extra-Oral Scanners, CAD software, CAM software, restoration material blanks, milling machines and associated tooling and accessories. The system is used to design and fabricate CAD/CAM milled coping, crown and bridge restorations to be cemented onto Straumann® Variobase® Abutments, as well as milled abutments to be affixed to the endosseous dental implants of the Straumann® Dental Implant System using a basal screw.

Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate device, Straumann CARES M-Series CAD/CAM System, and the reference devices in Table 2. The main technological difference is the implant to abutment interface of the Variobase Abutments. The BLX Variobase Abutments were cleared previously for centralized manufacturing at a Straumann Validated Milling Center with different restoration materials in K190040 and K190082. The in-lab workflow and the restoration materials (Zolid HT and Zolid SHT) are identical to the primary predicate.

K190662 is not included in Table 2 and is referenced for the MRI compatibility only.

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Straumann® CARES M-Series CAD/CAM System

FEATURE	SUBJECT DEVICE	PRIMARY PREDICATE DEVICE	REFERNCE DEVICE	REFERENCE DEVICE	EQUIVALENCE
	K203456	K171649	K190082	K190040	DISCUSSION
Indications forUse	The Straumann CARES M-SeriesCAD/CAM System is indicated forthe design and fabrication ofsingle or multiple-unit implant-borne prosthetics for therestoration of partially or fullyedentulous mandibles andmaxillae. The system integratesmultiple components of the digitaldentistry workflow: scan files fromIntra-Oral Scanners or Extra-OralScanners, CAD software, CAMsoftware, restoration materialblanks, milling machines andassociated tooling andaccessories. The system is usedto design and fabricateCAD/CAM milled coping, crownand bridge restorations to becemented onto Straumann®Variobase® Abutments, as well asmilled abutments to be affixed tothe endosseous dental implantsof the Straumann® Dental ImplantSystem using a basal screw.	The Straumann CARES M-SeriesCAD/CAM System is indicated forthe design and fabrication ofsingle or multiple-unit implant-borne prosthetics for therestoration of partially or fullyedentulous mandibles andmaxillae. The system integratesmultiple components of the digitaldentistry workflow: scan files fromIntra-Oral Scanners or Extra-OralScanners, CAD software, CAMsoftware, restoration materialblanks, milling machines andassociated tooling andaccessories. The system is usedto design and fabricateCAD/CAM milled coping, crownand bridge restorations to becemented onto Straumann®Variobase® Abutments, as well asmilled abutments to be affixed tothe endosseous dental implantsof the Straumann® Dental ImplantSystem using a basal screw.	Straumann® Variobase®prosthetic components directly orindirectly connected to theendosseous dental implant areintended for use as an aid inprosthetic rehabilitations. Theprosthetic restoration (crowns)can be cemented onto theStraumann® Variobase®prosthetic components. Atemporary restoration can beused prior to the insertion of thefinal components to maintain,stabilize and shape the softtissue during the healing phase;they must be placed out ofocclusion. Final abutments andrestorations may be placed intoocclusion when the implant isfully osseointegrated. All digitallydesigned copings and/or crownsfor use with the Straumann®Variobase® Abutment system areintended to be sent to Straumannfor manufacture at a validatedmilling center.	Straumann BLX Healing Abutments for Barsand BridgesStraumann Healing abutments are indicated tobe placed in the patient's mouth at the end ofthe implant placement to protect the innerconfiguration of the implant and to form,maintain and stabilize the soft tissue during thehealing process.Healing abutments should be used only withsuitable implant connections.Healing components have a maximum durationof usage of 6 months.Straumann BLX Temporary Abutments forBars and BridgesProsthetic components directly or indirectlyconnected to the endosseous dental implant areintended for use as an aid in prostheticrehabilitations. Temporary components can beused prior to the insertion of the finalcomponents to maintain, stabilize and shapethe soft tissue during the healing phase; theymay not be placed into occlusion. Finalabutments may be placed into occlusion whenthe implant is fully osseointegrated.BLX Temporary Abutments have a maximumduration of usage of 180 days.Straumann BLX Variobase Abutments forBar and BridgesStraumann® Variobase® prosthetic componentsdirectly or indirectly connected to theendosseous dental implant are intended for useas an aid in prosthetic rehabilitations. Theprosthetic restoration (bridge or overdenture)can be cemented on the Straumann®Variobase® prosthetic components. Atemporary restoration can be used prior to theinsertion of the final components to maintain,stabilize and form the soft tissue during thehealing phase. They may not be placed into	Identical to primarypredicate
FEATURE	SUBJECT DEVICEK203456	PRIMARY PREDICATE DEVICEK171649	REFERNCE DEVICEK190082	REFERENCE DEVICEK190040	EQUIVALENCEDISCUSSION
				occlusion. Final abutments and restorationsmay be placed into occlusion when the implantis fully osseointegrated.Straumann BLX Variobase Abutments ASThe Straumann Variobase for Crown AS is atitanium base placed onto Straumann dentalimplants to provide support for customizedprosthetic restorations. Straumann Variobasefor Crown AS are indicated for screw retainedsingle tooth or cement-retained single tooth andbridge restorations. A temporary restoration canbe used prior to the insertion of the finalcomponents to maintain, stabilize and form thesoft tissue during the healing phase. Temporaryrestorations are indicated to be placed out ofocclusion. All digitally designed copings and/orcrowns for use with the Straumann Variobasefor Crown AS are intended to be sent toStraumann for manufacture at a validatedmilling center.Straumann BLX Novaloc AbutmentsThe Straumann® Retentive System is indicatedfor the attachment of full or partial dentures onStraumann dental implants.
				Straumann BLX CARES AbutmentsThe Straumann CARES Abutments are in-dicated for single tooth replacement andmultiple tooth restorations.The prosthetic restoration can be cemented ordirectly veneered/screw-retained.
Source ofInput Files	Intra-Oral ScannerBench-top Scanners	Intra-Oral ScannerBench-top Scanners	N/A	N/A	Identical to primarypredicate
BenchScannerControl	Yes	Yes	N/A	N/A	Identical to primarypredicate
ImplantDetection	Yes, using Scanbodies	Yes, using Scanbodies	N/A	N/A	Identical to primarypredicate
FEATURE	SUBJECT DEVICEK203456	PRIMARY PREDICATE DEVICEK171649	REFERNCE DEVICEK190082	REFERENCE DEVICEK190040	EQUIVALENCEDISCUSSION
DesignEnvironment	Straumann CARES Visual:Closed CAD System facilitatingthe design of restorations used inconjunction with the devices ofthe Straumann Dental ImplantSystem (SDIS).	Straumann CARES Visual:Closed CAD System facilitatingthe design of restorations used inconjunction with the devices ofthe Straumann Dental ImplantSystem (SDIS).	N/A	N/A	Identical to primarypredicate
RestorationTypesSupported	Device-borne:Copings and crowns forVariobase AbutmentsBridges and bars for Variobasefor Bridge/Bar Abutments	Device-borne:Copings and crowns forVariobase AbutmentsCopings, crowns, and bridges forScrew-Retained AbutmentsBridges and bars for Variobasefor Bridge/Bar AbutmentsSolid TAN Abutments forStraumann Implants	Device-borne:Copings and crowns forVariobase Abutments	Device-borne:Bridges and bars for Variobase for Bridge/BarAbutments	Included in primarypredicateIdentical toreference devices
CompatibleImplants	Straumann Bone Level implantshaving the WB, RB/WB implant-to-abutment interface geometries.	Straumann Bone Level implantshaving the NC and RC implant-to-abutment interface geometries.Straumann Tissue Level implantshaving the NNC, RN, and WNimplant-to-abutment interfacegeometries.	Straumann Bone Level implantshaving the WB, RB/WB implant-to-abutment interface geometries.	Straumann Bone Level implants having the WB,RB/WB implant-to-abutment interfacegeometries.	Identical toreference devices
AbutmentPlatformDiameters	3.8 – 5.5 mm	3.8 – 7.0 mm	3.8 – 5.5 mm	4.5 mm	Identical toreference devices
AbutmentGingivaHeight (BoneLevel only)	1.5 – 3.5 mm	1.0 – 3.0 mm	1.5 – 3.5 mm	1.5 mm	Identical toreference devices
AbutmentMaterial	Titanium alloy(Ti-6Al-7Nb, TAN)	Titanium alloy(Ti-6Al-7Nb, TAN)	Titanium alloy(Ti-6Al-7Nb, TAN)	Titanium alloy(Ti-6Al-7Nb, TAN)	Identical
FEATURE	SUBJECT DEVICEK203456	PRIMARY PREDICATE DEVICEK171649	REFERNCE DEVICEK190082	REFERENCE DEVICEK190040	EQUIVALENCEDISCUSSION
SupportedRestorativeMaterials forTi-Bases	Amann Girrbach Ceramill ZOLIDHT (ZrO2)Amann Girrbach Ceramill ZOLIDSHT (ZrO2)Amann Girrbach Ceramill ZOLIDHT Preshade (ZrO2)	Amann Girrbach Ceramill ZOLIDZI (ZrO2)Amann Girrbach Ceramill ZOLIDHT (ZrO2)Amann Girrbach Ceramill ZOLIDSHT (ZrO2)Amann Girrbach Ceramill ZOLIDHT Preshade (ZrO2)Ivoclar IPS e.max CAD(K142890) Straumann n!ce GlassCeramic (K170354)	Two-piece abutment base withbonded prosthesis produced via:Digital Workflow:coron®zerion® LTzerion® ML and UTML	Two-piece abutment base forbridges/bars/overdentures with bondedprosthesis produced via:Materials cleared by the FDA under 21 CFR872.6660 or exempt materials as describedunder 21 CFR 872.3060 (Noble metal alloys)and 21 CFR 872.3710 (Base metal alloys).	Identical toPrimary Predicate
MaximumAnqulation	30° controlled in design software	30° controlled in design software	30° controlled in design software	30° controlled in design software	Identical
RestorationSizes	Device-borne:Single crown up to 16-Unit Bridge	Device-borne:Single crown up to 16-Unit Bridge	Device-borne:Single crown	Device-borne Bars/Bridges/Overdentures:Up to 16-Unit Bridge	Identical toPrimary Predicate
Interface to Ti-Base	Milled by the system using solidrestoration material discs	Milled by the system using solidrestoration material discs or C14blocks	N/A	N/A	Identical toPrimary Predicate
CAD to CAMTransfer	Seamless, same softwareinterface	Seamless, same softwareinterface	N/A	N/A	Identical toPrimary Predicate
CAMCapability	Nesting of multiple designs tomaximize use of material disks.Selection of tools, tool paths,speeds and feed rates that themill uses to produce an accuraterestoration.Encryption of milling file.	Nesting of multiple designs tomaximize use of material disks.Selection of tools, tool paths,speeds and feed rates that themill uses to produce an accuraterestoration.Encryption of milling file.	N/A	N/A	Identical toPrimary Predicate
CAM to MillTransfer	Encrypted file format assures thatthe M-Series Mills can onlyaccept files generated by theStraumann CARES Visual andCAM Module Software	Encrypted file format assures thatthe M-Series Mills can onlyaccept files generated by theStraumann CARES Visual andCAM Module Software	N/A	N/A	Identical toPrimary Predicate
SupportedMilles	Straumann CARES M-SeriesMills	Straumann CARES M-SeriesMills	N/A	N/A	Identical toPrimary Predicate
FEATURE	SUBJECT DEVICEK203456	PRIMARY PREDICATE DEVICEK171649	REFERNCE DEVICEK190082	REFERENCE DEVICEK190040	EQUIVALENCEDISCUSSION
FabricationWorkflow	Dry milling of partially crystallizedceramic blanks.	Dry milling of partially crystallizedceramic blanks.Wet milling of Ti-6Al-7Nb Pre-Milled Abutment Blanks, IvoclarIPS e.max CAD and nice GlassCeramic using coolant.	N/A	N/A	Identical toPrimary Predicate
Sterility	Provided non-sterile - terminallysterilized via autoclave prior toimplantation.	Provided non-sterile - terminallysterilized via autoclave prior toimplantation.	Provided non-sterile - terminallysterilized via autoclave prior toimplantation.	Provided non-sterile - terminally sterilized viaautoclave prior to implantation.	Identical

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Straumann® CARES M-Series CAD/CAM System

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Straumann® CARES M-Series CAD/CAM System

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Straumann® CARES M-Series CAD/CAM System

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

Table 2 – Comparison of subject device versus primary predicate device

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Straumann® CARES M-Series CAD/CAM System

510(k) Summary

Performance Testing

Comparative dynamic fatigue tests were conducted according to the FDA quidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann BLX Variobase® with Zolid SHT and Zolid HT crowns are equivalent to the primary predicate and reference devices.

The Milling System Validation was leveraged from K171649 to confirm the dimensions of the milled restoration were the same as the intended CAD design from CARES Visual. A Simulated Use validation was also leveraged from K171649 to confirm the scan, design, and production capability of the subject devices in CARES Visual. The subject devices were not considered a new worst case; therefore, the existing validations were referenced.

The subject device materials are identical to the predicate and reference device materials, therefore, no new issues regarding biocompatibility were raised.

The sterilization process for the Straumann Variobase® 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".

Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann BLX Variobase® Abutments restored with Zolid HT and Zolid SHT restorations manufactured via the Straumann CARES M-Series CAD/CAM System workflow are substantially equivalent to the primary predicate and reference 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.)