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 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.

AI/ML Overview

The provided document describes the acceptance criteria and the study that proves the Straumann CARES M-Series CAD/CAM System meets those criteria, primarily through a substantial equivalence comparison with predicate devices and various bench studies.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are not explicitly stated as numerical targets in the document. Instead, performance is demonstrated through a claim of "equivalence" to predicate devices, which implicitly means meeting the performance standards of those legally marketed devices. The reported device performance is presented as "Equivalent" for various features when compared to predicate devices.

Feature / Acceptance Criteria	Reported Device Performance (Equivalence Discussion)
Indications for Use (Straumann CARES M-SERIES CAD/CAM System vs. SIRONA DENTAL CAD/CAM SYSTEM)	Equivalent: The basic indication of providing support for prostheses scanning, design, and fabrication is the same. Support for TiBase-borne restorations is the same. The subject device indications refer to fabrication of coping, crowns, and bridges, including mesostructures (top-half of two-piece abutment), which are the same as referenced in the primary predicate indications. The crowns and bridges of the subject device are considered equivalent to hybrid abutments. The subject device also supports the fabrication of implant-connected solid abutments. This implies its performance meets the predicate for all these restoration types.
Source of Input Files	Equivalent: Capabilities of the subject device (Intra-Oral Scanner, Bench-top Scanners) include the scope of capabilities for the predicate device (Bench-top scanners).
Bench Scanner Control	Equivalent
Implant Detection	Equivalent: Both use Scanbodies.
Design Environment	Equivalent: Both are Closed CAD Systems facilitating the design of restorations, but for devices from different companies. Performance is considered equivalent in terms of design functionality.
Restoration Types Supported	Equivalent: Capabilities of the subject device (Copings/Crowns for Variobase, Copings/Crowns/Bridges for Screw-Retained Abutments, Bridges/Bars for Variobase for Bridge/Bar, Solid TAN Abutments) include the scope of capabilities for the predicate device (Copings/Crowns for TiBase, Copings/Crowns for Camlog Titanium Base). Both allow design and fabrication of the mesostructure for two-piece abutments (standard coping or hybrid crown/bridge). The subject device also allows design and fabrication of a one-piece titanium abutment. The areas of the abutment available for design are equivalent.
Supported Hardware Devices	Equivalent: Capabilities of the subject device (Straumann Variobase Abutments, Straumann Screw-Retained Abutments, Solid abutments) include the scope of capabilities for the predicate device (Sirona Ti-bases, Camlog Titanium Base). The subject devices provide support for implant-connected abutments.
Supported Restorative Materials	Equivalent: ZrO2 Ceramic material with indications according to ISO 6872 Classification are equivalent. The ZrO2 materials for use with the Straumann CARES M-Series CAD/CAM System have been previously cleared by FDA. The TAN material is identical to material used in CARES TAN Abutments (K150899). Straumann n!ce Blocks for Amann Girrbach were previously cleared (K170420). The use of the Ivoclar IPS e.max CAD material with Variobase Abutments has been cleared (K142890). The use of the n!ce material with Variobase Abutments has been cleared (K170354). This implies the milling performance and material properties for these materials meet prior predicate standards.
Restoration Sizes	Equivalent: Capabilities of the subject device (Single crown up to 16-Unit bridge) include the scope of capabilities for the predicate device (Single crown). Support of bridges through two or more implants is achieved through Variobase for Bridge/Bar abutments (K151157). Use of multiple implants in the bridge limit the force on the individual implant to be less or equivalent to that of the single crown. For a 16-unit bridge, the force is spread over 4 or more implants.
Interface to Ti-Base	Equivalent: The ability of the subject device to use solid blocks provides greater design flexibility to the user (compared to predicate's pre-milled blocks).
CAD to CAM Transfer	Equivalent: Seamless, same software interface.
CAM Capability	Equivalent: Capabilities of the subject device (Nesting, selection of tools/paths/speeds/feed rates, encryption) include the scope of capabilities for the predicate device (selection of tools/paths/speeds/feed rates).
CAM to Mill Transfer	Equivalent: Capabilities of the subject device (encrypted file format ensuring only Straumann CARES Visual and CAM Module files are accepted) include or exceed the scope of capabilities for the predicate device (expected transfer encryption).
Supported Mills	Equivalent: Capabilities of the subject device (Straumann CARES M-Series Mills) include the scope of capabilities for the predicate device (CEREC MCXL Mill, inLab MCXL Mill).
Fabrication Workflow	Equivalent: Capabilities of the subject device (Dry milling of partially crystallized ceramic, Wet milling of Ti-6Al-7Nb Pre-Milled Abutment Blanks, Ivoclar IPS e.max CAD, and n!ce Glass Ceramic) include the scope of capabilities for the predicate device (In-lab wet milling of pre-sintered ceramic blocks).
Variobase Abutments: Indications for Use	Identical to predicate Straumann Variobase Abutments (K142890, K120822).
Variobase Abutments: Ti-base Material	Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb).
Variobase Abutments: Abutment Diameter	Identical: 3.8 – 7.0 mm.
Variobase Abutments: Abutment Height	Identical: 3.5 – 4.5 mm.
Variobase Abutments: Coping/Crown Material	Equivalent/Identical: Digital workflow is expanded to add additional materials (Ceramill ZOLID series, Ivoclar IPS e.max CAD, Straumann n!ce). The Zi, ZOLID series are equivalent to predicate's zerion ZrO2 material. Use of n!ce and IPS e.max CAD is identical to previously cleared devices.
Variobase Abutments: Design Workflow	Equivalent: Subject employs a subset of predicate's techniques (CAD vs. Wax-up or CAD).
Variobase Abutments: Fabrication Workflow	Equivalent: Restorations milled by the dental laboratory are equivalent to those produced by the Straumann milling center.
Variobase Abutments: Mode of Attachment	Identical: Screw-retained or cement retained.
Variobase Abutments: Reusable	Identical: No.
Laboratory Milled CARES® TAN Abutments: Indications for Use	Identical to predicate Straumann® CARES® TAN Abutments (K150899).
Laboratory Milled CARES® TAN Abutments: Abutment Material	Identical: Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN).
Laboratory Milled CARES® TAN Abutments: Abutment Apical Design	Identical: Engaging, BoneLevel (NC, RC), Tissue Level (RN, WN).
Laboratory Milled CARES® TAN Abutments: Abutment Coronal Design	Identical: CADCAM design process, designs controlled by material-specific design limits in CARES Visual CAD software, model verification by CAM software, and milling blank dimensions.
Laboratory Milled CARES® TAN Abutments: CAD Design Limits	Identical: Max. Angulation 30°, Emergence Offset 0.1 mm, Emergence Angle 65°, Min. Thickness 0.4 mm, Smooth Distance 0.5 mm, Min post surface area 37 to 56mm².
Laboratory Milled CARES® TAN Abutments: Fabrication Method	Equivalent: Both methods use Straumann CARES Visual CAD software for design, applying the same validated limits. The difference is the manufacturing location (QSR controlled vs. dental laboratory). The milling accuracy of the Straumann CARES M-Series CAD/CAM System has been validated. Labeling has been revised and validated for milling unit installation, maintenance, and required tools/machine liquids/material blocks to ensure equivalence.
Laboratory Milled CARES® TAN Abutments: Directly Veneerable?	Identical: Yes.

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

The document does not specify a separate "test set" sample size in the context of clinical studies with patients. The studies conducted are primarily bench studies involving laboratory testing of materials and device components. The number of samples for each type of bench test (fatigue, biocompatibility, etc.) is not detailed in this summary, but these are typically standardized tests with a defined number of specimens as per the relevant ISO or FDA guidance.

The data provenance is not explicitly stated as "country of origin" or "retrospective/prospective" clinical data, as it primarily refers to bench testing data. These tests would have been performed in a controlled laboratory environment.

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

This information is not applicable. The evaluations are based on engineering and material performance specifications (bench studies) and comparison to predicate devices, not on expert clinical review of a test set for establishing ground truth in a diagnostic sense.

4. Adjudication Method for the Test Set

This information is not applicable, as the evaluation is based on bench testing and comparison to technical specifications, not human adjudication of diagnostic data.

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 information is not applicable. The device is a CAD/CAM system for fabricating dental prosthetics, not an AI-assisted diagnostic tool for human readers. Therefore, an MRMC study related to improving human reader performance with AI is not relevant to this submission.

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

The document describes the Straumann CARES M-Series CAD/CAM System as an integrated system involving CAD software, CAM software, milling machines, and material blanks. The "algorithm" component is the CAD/CAM software. The system's performance is inherently "standalone" in its function of designing and fabricating prosthetics based on input scan files, but it is a tool used by human operators (dental technicians/laboratories). The bench studies performed evaluate the output of this system (e.g., strength of the milled prosthetics), which indirectly assesses the standalone performance of the algorithms and hardware in creating the physical restorations.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

For the bench studies, the "ground truth" refers to established engineering and material standards. Specifically:

Dynamic fatigue testing: Conforming to FDA guidance and ISO 14801. The ground truth is the performance criteria defined by these standards.
Software validation: Conforming to the requirements of IEC 62304. The ground truth is compliance with this software safety standard.
Sterilization validation: Conforming to ISO 17665-1 and ISO/TS 17665-2. The ground truth is achieving sterility assurance levels defined by these standards.
Biocompatibility testing: Conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, and ISO 10993-18. The ground truth is meeting the safety criteria for biological interaction.
Electrical safety testing: Conforming to IEC 61010-1 and IEC 61010-2-010. The ground truth is compliance with electrical safety standards.

For the substantial equivalence comparison, the "ground truth" is the performance and characteristics of the legally marketed predicate devices.

8. The Sample Size for the Training Set

The document does not refer to a "training set" in the context of machine learning. The CAD/CAM software is likely based on computational design and manufacturing principles, not on a machine learning model that requires a labeled training set derived from large datasets of past cases. Therefore, this concept is not applicable here.

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

As there is no "training set" in the machine learning sense, this question is not applicable. The underlying principles for the software's functionality would stem from dental anatomical knowledge, engineering mechanics, material science, and manufacturing tolerances, which form the basis of its deterministic operation.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

February 22, 2018

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

Re: K171649

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: January 22, 2018 Received: January 23, 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.

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 (QS) regulation (21 CFR Part 820);

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Page 2 - Jennifer Jackson

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,

Mary S. Runner -S

forTina 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 Druq Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K171649

Device Name

Straumann CARES M-Series CAD/CAM System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Subpart C)

| | Over-The-Counter Use (21 CFR 801

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)Equivalent

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510(k) Summary

Submitter:	Straumann USA, LLC (on behalf of Institut Straumann AG)60 Minuteman RoadAndover, MA 01810
Contact Person:	Jennifer M. Jackson, MSDirector of Regulatory Affairs and Quality
Prepared By:	Gordon DoddsManager Design Control QMEtkon GmbH
Date Prepared:	February 21, 2018
Product Code(s):	NHA (21 CFR 872.3630)PNP (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® CARES M-Series CAD/CAM System
Predicate Device(s):	• K111421 SIRONA DENTAL CAD/CAM SYSTEM
Reference Device(s):	• K120822 Straumann CARES Variobase Abutment• K133421 Magellan Screw-Retained Abutments• K152383 Ceramill ZOLID fx• K063511 Ceramill ZI• K151157 Variobase for Bridge/Bars• K150899 Straumann CARES TAN Abutments• K142890 Straumann Variobase Abutment• K170354 Straumann Variobase Abutments• K150203 Medentika CAD/CAM Abutments
Device Description:	The Straumann CARES M-Series CAD/CAM System isintended for the design and fabrication of dental restorations bydental laboratories by means of a digital workflow.The Straumann CARES M-Series CAD/CAM System employsoptical impression files that document the topographical

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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.

The supported dental restorative devices are described in the following table:

Type	Implant-borne	Picture
Coping1	Using previously cleared Variobase Abutments	Image: Coping
Crown1	Using previously cleared Variobase Abutments	Image: Crown
Bridge1	Using previously cleared Variobase Abutments	Image: Bridge
Abutment	Using subject Pre-Milled Abutment Blank	Image: Abutment

1 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.

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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 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 three-dimensional geometry is created that is linked to the selected restorative material/milling blank. The use of 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 be 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.

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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.

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 loads 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 after milling in order to achieve their final form. This is carried out in a sintering furnace.

The materials that require sintering are to be larger than the final 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. Straumann will market its own material Straumann® n!ce, Ivoclar's IPS e.max CAD and co-branded versions of milling blanks currently marketed by Amann Girrbach in the United States. These materials and their design control limits are identified in the table below.

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ProductName	Material	Min postheightmm	Maxangulation	MinGingivaheightmm	Min wallthicknessmm
Zi	ZrO2	4.0	30°	1	0.6
Zolid HT	ZrO2	4.0	30°	1	0.6
Zolid SHT	ZrO2	4.0	30°	1	0.95
Zolid HTPreshade	ZrO2	4.0	30°	1	0.6
n!ce	Glassceramic	4.0	30°	1	1.05
IPS e.maxCAD	Glassceramic	4.0	30°	1	0.75 topre-molar0.95molar

This submission also introduces new milling blanks suitable for fabricating solid customized abutments that attach directly to the implants of the Straumann Dental Implant System. The Pre-Milled Abutment Blank devices are produced from Ti-6Al-7Nb alloy. They have the designated Straumann implant-toabutment connection pre-milled at the apical end of the blank. The emergence profile and coronal segments of the blank consists of a solid cylinder available in one 12 mm diameter. The four configurations and design control limits are shown in the table below.

Product Name	Material	Implant-to-Abutment Interface	Min post surface area	Max angulation	Min wall thickness mm	Min Gingiva height mm
PMAB	TAN	Bone LevelNarrow CrossFit® (NC)	37 mm2 to 56 mm2 dependent on tooth position	30°	0.4	0.87
PMAB	TAN	Bone LevelRegular CrossFit® (RC)	This corresponds to a minimum height of ~4 mm	30°	0.4	0.87
PMAB	TAN	Tissue LevelRegular Neck (RN)		30°	0.4	N/A
PMAB	TAN	Tissue LevelWide Neck (WN)		30°	0.4	N/A

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The following schematic illustrates how the different components of the CARES M-Series CAD/CAM system work together.

Image /page/8/Figure/2 description: The image shows a diagram of the process for creating dental prostheses. The process starts with a scan file of the patient's dentition, which is used to create a CARES visual design. The design is then sent to an M-Series Mill, which uses a milling blank or a pre-milled abutment blank to create the prosthesis. Finally, the prosthesis is sent to a sinter oven to be completed.

Figure 1 Workflow from scanning to completed prostheses

Indications For Use:	The Straumann® CARES® M-Series CAD/CAM System isindicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially orfully edentulous mandibles and maxillae. The systemintegrates multiple components of the digital dentistryworkflow: scan files from Intra-Oral Scanners or Extra-OralScanners, CAD software, CAM software, restoration materialblanks, milling machines and associated tooling andaccessories. The system is used to design and fabricateCAD/CAM milled coping, crown and bridge restorations to becemented onto Straumann® Variobase® Abutments, as well asmilled abutments to be affixed to the endosseous dentalimplants of the Straumann® Dental Implant System using abasal screw.
Intended Use:	The Straumann CARES M-Series CAD/CAM System isintended to be used for the design and fabrication of patient-specific dental restorations. The dental restorations are intendedto restore dental implants, either directly (CAD/CAM milledabutment) or via a Ti-base style abutment (Straumann tradename Variobase).

Indications For Use:

The Straumann® CARES® M-Series CAD/CAM System isindicated for the design and fabrication of single or multiple-unit implant-borne prosthetics for the restoration of partially orfully edentulous mandibles and maxillae. The systemintegrates multiple components of the digital dentistryworkflow: scan files from Intra-Oral Scanners or Extra-OralScanners, CAD software, CAM software, restoration materialblanks, milling machines and associated tooling andaccessories. The system is used to design and fabricateCAD/CAM milled coping, crown and bridge restorations to becemented onto Straumann® Variobase® Abutments, as well asmilled abutments to be affixed to the endosseous dentalimplants of the Straumann® Dental Implant System using abasal screw.

Intended Use:

The Straumann CARES M-Series CAD/CAM System isintended to be used for the design and fabrication of patient-specific dental restorations. The dental restorations are intendedto restore dental implants, either directly (CAD/CAM milledabutment) or via a Ti-base style abutment (Straumann tradename Variobase).

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The Straumann CARES M-Series CAD/CAM System also supports the design and fabrication of two styles of implantborne dental restorations. Prostheses consist of stock Variobase Abutments (generically known as Ti-bases) with customized ceramic or glass-ceramic restorations cemented in place that mount directly onto Straumann NC, RC, RN and WN implants. The combination of the ceramic restoration and 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, see Figure 2 for examples of the Variobase/restoration two-piece combinations.

Image /page/9/Figure/2 description: The image shows two diagrams of dental implants. The diagram on the left shows two implants with a bridge connecting them. The implants are angled up to 30 degrees apart. The diagram on the right shows a single implant with a basal screw, prosthetic restoration, and Straumann Variobase abutment.

Figure 2 Two-piece Straumann® Variobase™ Abutments for Bridges/Bars (left) and Crowns (right)

The Straumann CARES Pre-Milled Abutment Blank (PMAB) is designed and milled to create a customized abutment that engages directly to the implant. The implant engaging part and screw-seat/channel of the CARES Pre-Milled Abutment Blank is already pre-manufactured by Straumann as delivered to the customer and will not be modified by milling in the laboratory, see Figure 3.

Image /page/9/Picture/5 description: The image shows two dental implants. The implant on the left is a cylindrical metal post with a U-shaped notch at the top. The implant on the right is shaped like a tooth with a metal base. Both implants are silver in color and appear to be made of metal.

Figure 3 Left: PMAB with milling machine clamping mechanism at top and pre-milled interface to dental implant at bottom. Right: Patient-specific abutment milled from a blank

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Milling Blank	Material
Pre-Milled AbutmentBlank	TAN (Ti6A7Nb)
Ceramill ZOLID fx(Straumann brandZolid SHT)	ZrO2 (YSZ)- Yttria-stabilized zirconia
Ceramill Zi(Straumann brandZolid HT and Zi)	ZrO2 (YSZ)
IPS e.max CAD	Lithium-disilicateglass-ceramic
n!ce	Lithium-aluminosilicate withLithium-disilicateglass-ceramic

Pre-Milled Abutment Blanks are manufactured from titanium-6aluminum-7niobium alloy (TAN). This material is identical to the material used to produce the reference CARES TAN Abutments (K150899).

Technological Characteristics:

Materials:

See Table below

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Table 1: Substantial Equivalence Comparison – Straumann CARES M-Series CAD/CAM System

FEATURE	SUBJECTStraumann® CARES® M-SeriesCAD/CAM System	PREDICATESIRONA DENTAL CAD/CAMSYSTEM (K111421)	EquivalenceDiscussion
Indications for Use	The Straumann CARES M-SeriesCAD/CAM System is indicated for thedesign and fabrication of single ormultiple-unit implant-borne prosthetics forthe restoration of partially or fullyedentulous mandibles and maxillae. Thesystem integrates multiple components ofthe digital dentistry workflow: scan filesfrom Intra-Oral Scanners or Extra-OralScanners, CAD software, CAM software,restoration material blanks, millingmachines and associated tooling andaccessories. The system is used to designand fabricate CAD/CAM milled coping,crown and bridge restorations to becemented onto Straumann® Variobase®Abutments, as well as milled abutments tobe affixed to the endosseous dentalimplants of the Straumann® DentalImplant System using a basal screw.	The Sirona Dental CAD/CAM System isintended for use in partially or fullyedentulous mandibles and maxillae insupport of single or multiple-unit cementretained restorations. For the titaniumbases SSO 3.5 Land SBL 3.3 L, theindication is restricted for replacement ofsingle lateral incisors in the maxilla andlateral and central incisors in the mandible.The system consists of three major parts:TiBase, inCoris mesostructure, andCAD/CAM software. Specifically, theinCoris mesostructure and TiBasecomponents make up a two-pieceabutment which is used in conjunctionwith endosseous dental implants to restorethe function and aesthetics in the oralcavity. The inCoris mesostructure mayalso be used in conjunction with theCamlog Titanium base CAD/CAM (typesK2244.xxxx) (K083496) in the CamlogImplant System. The CAD/CAM softwareis intended to design and fabricate theinCoris mesostructure.The inCoris mesostructure and TiBasetwo-piece abutment is compatible with thefollowing implants systems:• Nobel Biocare Replace (K020646)• Nobel Biocare Branemark (K022562)· Friadent Xive (K013867)· Biomet 3i Osseotite (K980549)• Astra Tech Osseospeed (K091239)· Zimmer Tapered Screw-Vent (K061410)· Straumann SynOcta (K061176)	EquivalentThe basic indication of providing supportfor prostheses scanning, design andfabrication is the same.Support for TiBase-borne restorations isthe same. The subject device indicationsrefer to fabrication of coping, crowns andbridges. The proposed copings, crownsand bridges include the mesostructure (ortop-half of two-piece abutment), which arethe same as referenced in the primarypredicate indications. The crowns andbridges of the subject device may bereferred to as hybrid abutments and aretherefore equivalent.The subject device also supports thefabrication of implant connected solidabutments.
FEATURE	SUBJECTStraumann® CARES® M-SeriesCAD/CAM System	PREDICATESIRONA DENTAL CAD/CAMSYSTEM (K111421)	EquivalenceDiscussion
		• Straumann Bone Level (K053088,K062129, K060958)• Biomet 3i Certain (K014235, K061629)• Nobel Biocare Active (K071370)
Source of InputFiles	Intra-Oral ScannerBench-top Scanners	Bench-top scanners	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice.
Bench ScannerControl	Yes	Yes	Equivalent
Implant Detection	Yes, using Scanbodies	Yes, using Scanbodies	Equivalent
Design Environment	Straumann CARES Visual:Closed CAD System facilitating the designof restorations used in conjunction with thedevices of the Straumann Dental ImplantSystem (SDIS).	Sirona Dental CAC/CAM SoftwareClosed CAD System facilitating the designof restorations used in conjunction with theSirona TiBase devices and CamlogTitanium Base CAD/CAM devices.	EquivalentBoth systems support the design andfabrication of device-borne restorations,but for devices from different companies.
Restoration TypesSupported	Device-borne:Copings and crowns for VariobaseAbutmentsCopings, crowns and bridges for Screw-Retained AbutmentsBridges and bars for Variobase forBridge/Bar AbutmentsSolid TAN Abutments for StraumannImplants	Device-borne:Copings and crowns for TiBase devicesCopings and crowns for Camlog TitaniumBase devices	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice. Both devices allow design andfabrication of the mesostructure for a two-piece abutment (standard coping or hybridcrown/bridge). The subject device alsoallows design and fabrication of a one-piece titanium abutment. The areas of theabutment available for design areequivalent.
SupportedHardware Devices	• Straumann Variobase Abutments forNC, RC, NNC, RN and WN implant-to-abutment interfaces (K120822).• Straumann Variobase Abutments forBridges and Bars for NC, RC, NNC, RN	• Sirona Ti-bases for use with thefollowing implant systems:• Nobel Biocare Replace (K020646)• Nobel Biocare Branemark (K022562)• Friadent Xive (K013867)• Biomet 3i Osseotite (K980549)• Astra Tech Osseospeed (K091239)	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice related to support for titanium basestyle abutments. The subject devices
FEATURE	SUBJECTStraumann® CARES® M-SeriesCAD/CAM System	PREDICATESIRONA DENTAL CAD/CAMSYSTEM (K111421)	EquivalenceDiscussion
	and WN implant-to-abutment interfaces(K151157)• Copings for Straumann Screw-RetainedAbutments (K133421).• Solid abutments for connection withNC, RC, RN and WN implants of theSDIS using the subject Pre-MilledAbutment Blanks.	• Zimmer Tapered Screw-Vent(K061410)• Straumann SynOcta (K061176)• Straumann Bone Level (K053088,K062129, K060958)• Biomet 3i Certain (K014235,K061629)• Nobel Biocare Active (K071370)• Camlog Titanium Base CAD/CAM	provide support for implant connectedabutments.
SupportedRestorativeMaterials	• Ceramill ZOLID fx ZrO2• Ceramill ZI ZrO2• Ceramill ZOLID ZrO2• Titanium-6Aluminum-7Niobium alloyor TAN (Subject Pre-Milled AbutmentBlanks)• Ivoclar IPS e.max CAD• Straumann n!ce Glass Ceramic	• InCoris pre-sintered Ceramic (K062509)ZrO2	EquivalentZrO2 Ceramic material with indicationsaccording to ISO 6872 Classification areequivalent. The ZrO2 materials for usewith the Straumann CARES M-SeriesCAD/CAM System have been previouslycleared by FDA.The TAN material is identical to materialused in CARES TAN Abutments clearedto market per K150899.Straumann n!ce Blocks for AmannGirrbach were previously cleared perK170420.The use of the Ivoclar IPS e.max CADmaterial with Variobase Abutments hasbeen cleared per K142890.The use of the n!ce material withVariobase Abutments has been cleared perK170354.
Restoration Sizes	Device-borne:Single crown up to 16-Unit bridge	Device-borne:Single crown	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice.Support of bridges through two or moreimplants is achieved through Variobase for
FEATURE	SUBJECTStraumann® CARES® M-SeriesCAD/CAM System	PREDICATESIRONA DENTAL CAD/CAMSYSTEM (K111421)	EquivalenceDiscussion
Interface to Ti-Base	Milled by the system using solidrestoration material discs or C14 blocks	Pre-milled in the A14 block material	Bridge/Bar abutments (K151157). Use ofmultiple implants in the bridge limit theforce on the individual implant to be lessor equivalent to that of the single crown.For a 16-unit bridge, the force is spreadover 4 or more implants.EquivalentThe ability of the subject device to usesolid blocks provides greater designflexibility to the user.
CAD to CAMTransfer	Seamless, same software interface	Seamless, same software interface	Equivalent
CAM Capability	Nesting of multiple designs to maximiseuse of material discsSelection of tools, tool paths, speeds andfeed rates that the mill uses to produce anaccurate restorationEncryption of milling file	Selection of tools, tool paths, speeds andfeed rates that the mill uses to produce anaccurate restoration	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice.
CAM to MillTransfer	Encrypted file format assures that the M-Series, Mills can only accept filesgenerated by the Straumann CARESVisual and CAM Module software	It would be expected that the transfer isencrypted - the transfer protectionmechanism is not publically available.	EquivalentCapabilities of subject device include orexceed the scope of capabilities for thepredicate device.
Supported Mills	Straumann CARES M-Series, Mills	CEREC MCXL MillinLab MCXL Mill	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice.
FabricationWorkflow	Dry milling of partially crystallizedceramic blanksWet milling of Ti-6Al-7Nb Pre-MilledAbutment Blanks, Ivoclar IPS e.max CADand n!ce Glass Ceramic using coolant	In-lab wet milling of pre-sintered ceramicblocks using coolant	EquivalentCapabilities of subject device include thescope of capabilities for the predicatedevice.

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FEATURE	SUBJECTStraumann® CARES® M-SeriesCAD/CAM System	PREDICATESIRONA DENTAL CAD/CAMSYSTEM (K111421)	EquivalenceDiscussion

Table 2: Substantial Equivalence Comparison – Abutment Borne Restorations

Feature	SUBJECTStraumann Variobase Abutments	PREDICATEStraumann Variobase Abutments(K142890, K120822)	Equivalence Discussion
Indications for Use	The Straumann CARES M-SeriesCAD/CAM System is indicated for thedesign and fabrication of single ormultiple-unit implant-borne prosthetics forthe restoration of partially or fullyedentulous mandibles and maxillae. Thesystem integrates multiple components ofthe digital dentistry workflow: scan filesfrom Intra-Oral Scanners or Extra-OralScanners, CAD software, CAM software,restoration material blanks, millingmachines and associated tooling andaccessories. The system is used to designand fabricate CAD/CAM milled coping,crown and bridge restorations to becemented onto Straumann® Variobase®Abutments, as well as milled abutments tobe affixed to the endosseous dentalimplants of the Straumann® DentalImplant System using a basal screw.	The Straumann® Variobase™ Abutment isa titanium base placed onto Straumanndental implants to provide support forcustomized prosthetic restorations.Straumann® Variobase™ Abutments areindicated for screw-retained single tooth orcement-retained single tooth and bridgerestorations.	Identical
Ti-baseMaterial	Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb)	Titanium-Aluminum-Niobium alloy(Ti-6Al-7Nb)	Identical
Abutment Diameter	3.8 – 7.0 mm	3.8 – 7.0 mm	Identical
Abutment Height	3.5 – 4.5 mm	3.5 – 4.5 mm	Identical
Feature	SUBJECTStraumann Variobase Abutments	PREDICATEStraumann Variobase Abutments(K142890, K120822)	Equivalence Discussion
Coping/ CrownMaterial	The following materials are being added tothe previously cleared coping/crownmaterials:Amann Girrbach Ceramill ZOLID ZI(ZrO2)Amann Girrbach Ceramill ZOLID HT(ZrO2)Amann Girrbach Ceramill ZOLID SHT(ZrO2)Amann Girrbach Ceramill ZOLID HTPreshade (ZrO2)Ivoclar IPS e.max CAD (K142890)Straumann n!ce Glass Ceramic (K170354)	Traditional Workflow:Type 4 Metals (ISO 22674)IPS e.max® Press CeramicDigital Workflow:polycon® ae (temporary)zerion® (permanent)IPS e.max® CAD Ceramic (permanent)coron® (permanent)	EquivalentThe digital workflow is being expanded toadd additional materials.. The Zi, ZOLID series of materials areequivalent to the zerion ZrO2 material.IdenticalThe use of the n!ce material withVariobase Abutments is identical toK170354.The use of the Ivoclar IPS e.max CADwith Variobase Abutments is identical toK142890.
Design Workflow	CAD	Wax-up or CAD	EquivalentThe subject device employs a subset of thetechniques employed for the predicatedevices.
FabiricationWorkflow	Milling by the dental laboratory	Traditional casting or pressing by thedental laboratoryorCAM by Straumann Milling Center	EquivalentThe restorations milled by the dentallaboratory are equivalent to thoseproduced by the Straumann milling center.
Mode of Attachment	Screw-retained or cement retained	Screw-retained or cement retained	Identical
Reusable	No	No	Identical

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Feature	SubjectLaboratory Milled CARES® TANAbutments	PredicateStraumann® CARES® TAN Abutments(K150899)	EquivalenceDiscussion
Indications for Use	The Straumann CARES M-SeriesCAD/CAM System is indicated for thedesign and fabrication of single ormultiple-unit implant-borne prosthetics forthe restoration of partially or fullyedentulous mandibles and maxillae. Thesystem integrates multiple components ofthe digital dentistry workflow: scan filesfrom Intra-Oral Scanners or Extra-OralScanners, CAD software, CAM software,restoration material blanks, millingmachines and associated tooling andaccessories. The system is used to designand fabricate CAD/CAM milled coping,crown and bridge restorations to becemented onto Straumann® Variobase®Abutments, as well as milled abutmentsto be affixed to the endosseous dentalimplants of the Straumann® DentalImplant System using a basal screw.	The Straumann CARES® TAN abutmentsare indicated for single tooth replacementand multiple tooth restorations. Theprosthetic restoration can be cemented ordirectly veneered/ screw-retained.	Identical
AbutmentMaterial	Titanium-Aluminum-Niobium alloy (Ti-6A1-7Nb, TAN)	Titanium-Aluminum-Niobium alloy (Ti-6Al-7Nb, TAN)	Identical
Abutment ApicalDesign	EngagingBoneLevelNarrow CrossFit (NC)Regular CrossFit (RC)Tissue LevelRegular Neck (RN)Wide Neck (WN)	EngagingBoneLevelNarrow CrossFit (NC)Regular CrossFit (RC)Tissue LevelRegular Neck (RN)Wide Neck (WN)	Identical
Feature	SubjectLaboratory Milled CARES® TANAbutments	PredicateStraumann® CARES® TAN Abutments(K150899)	EquivalenceDiscussion
Abutment CoronalDesign	CADCAM design process.Designs controlled by material-specificdesign limits in the CARES Visual CADsoftware, model verification performed bythe CAM software and milling blankdimensions used by the Straumann millingcenter.	CADCAM design process.Designs controlled by material-specificdesign limits in the CARES Visual CADsoftware, model verification performed bythe CAM software and milling blankdimensions used by the Straumann millingcenter.	Identical
CAD Design Limits	Max. Angulation30°Emergence Offset0.1 mmEmergence Angle65°Min. Thickness0.4 mmSmooth Distance0.5 mmMin post surface area37 to 56mm²	Max. Angulation30°Emergence Offset0.1 mmEmergence Angle65°Min. Thickness0.4 mmSmooth Distance0.5 mmMin post surface area37 to 56mm²	Identical
Fabrication Method	Dental laboratory mills using theStraumann CARES M-Series CAD/CAMSystems and the subject Pre-MilledAbutment Blank.	CAM by Straumann Milling Center.	EquivalentBoth methods make use of the StraumannCARES Visual CAD software to designthe abutment, so the same validated limitsare applied. The difference is thetransition from a QSR controlledmanufacturing location to a dentallaboratory.The milling accuracy of the StraumannCARES M-Series CAD/CAM System hasbeen validated. Labeling has been revisedand validated for milling unit installation,maintenance, and required tools/machineliquids/material blocks to ensureequivalence.
DirectlyVeneerable?	Yes	Yes	Identical

Table 3: Substantial Equivalence Comparison – Implant-Borne Restorations

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Performance Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Data: Document: Root-form 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 and is summarized for each new material and device type in the table below, with reference to predicates:

Dynamic fatigue testing conforming to FDA guidance and ISO 14801.
Software validation conforming to the requirements of IEC 62304. ●
Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.
. Biocompatibility testing conforming to ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11 and ISO 10993-18.
Electrical safety testing conforming to IEC 61010-1 and IEC 61010-2-010.

Variobasematerials	Fatigue tests -predicates	Sterilizationvalidationpredicates	Biocompatibilitytesting -predicates
Zi	K142890	K142890	K063511
Zolid HT	K142890	K142890	K063511
Zolid SHT	K142890 K150203	K142890	K152383
n!ce	K170354	K170354	K170354
IPS e.maxCAD	K142890	K142890	K142890

PMABmaterials	Fatigue testspredicates	Sterilizationvalidationpredicates	Biocompatibilitytesting –predicates
TAN	K150899	K150899	K150899

Conclusions: 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.

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.)