Straumann CARES M-Series CAD/CAM System

K171649 · Institut Straumann AG · NHA · Feb 22, 2018 · Dental

Device Facts

• Record ID: K171649
• Device Name: Straumann CARES M-Series CAD/CAM System
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Feb 22, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

System integrates digital dentistry workflow components: intra-oral/extra-oral scanner files, CAD software, CAM software, material blanks, and milling machines. Scanner inputs document tooth/implant topography. CARES Visual CAD software designs restorations; CAM module converts geometry to milling commands, including nesting for material optimization. Milling files are encrypted to ensure compatibility only with validated M-Series mills. Used in dental laboratories by technicians. System produces CAD/CAM milled copings, crowns, bridges, and customized abutments. Benefits include patient-specific restoration fit and streamlined digital fabrication. Healthcare providers use these prosthetics to restore dental implant function and aesthetics.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing (ISO 14801), software validation (IEC 62304), sterilization validation (ISO 17665-1/2), biocompatibility testing (ISO 10993 series), and electrical safety testing (IEC 61010-1/2-010). No clinical data provided.

Technological Characteristics

System includes CAD/CAM software, milling machine, and material blanks (ZrO2, Lithium-disilicate, Ti-6Al-7Nb). Sensing via optical scanners. Connectivity: encrypted file transfer between CAM software and mill. Sterilization: validated per ISO 17665. Software: CAD/CAM workflow with material-specific design limits (e.g., min wall thickness, max angulation).

Indications for Use

Indicated for design and fabrication of single or multiple-unit implant-borne prosthetics for restoration of partially or fully edentulous mandibles and maxillae. Used for CAD/CAM milled coping, crown, and bridge restorations cemented onto Straumann Variobase Abutments, and milled abutments affixed to Straumann Dental Implant System implants using a basal screw.

Regulatory Classification

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.

Special Controls

*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.)

Predicate Devices

• SIRONA DENTAL CAD/CAM SYSTEM (K111421)

Reference Devices

• Straumann CARES Variobase Abutment (K120822)
• Magellan Screw-Retained Abutments (K133421)
• Ceramill ZOLID fx (K152383)
• Ceramill ZI (K063511)
• Variobase for Bridge/Bars (K151157)
• Straumann CARES TAN Abutments (K150899)
• Straumann Variobase Abutment (K142890)
• Straumann Variobase Abutments (K170354)
• Medentika CAD/CAM Abutments (K150203)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

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FORM FDA 3881 (8/14)Equivalent

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# 510(k) Summary

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810 | | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality | | |
| Prepared By: | Gordon Dodds<br>Manager Design Control QM<br>Etkon GmbH | | |
| Date Prepared: | February 21, 2018 | | |
| Product Code(s): | NHA (21 CFR 872.3630)<br>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<br>• K133421 Magellan Screw-Retained Abutments<br>• K152383 Ceramill ZOLID fx<br>• K063511 Ceramill ZI<br>• K151157 Variobase for Bridge/Bars<br>• K150899 Straumann CARES TAN Abutments<br>• K142890 Straumann Variobase Abutment<br>• K170354 Straumann Variobase Abutments<br>• K150203 Medentika CAD/CAM Abutments | | |
| Device Description: | The Straumann CARES M-Series CAD/CAM System is<br>intended for the design and fabrication of dental restorations by<br>dental laboratories by means of a digital workflow.<br><br>The Straumann CARES M-Series CAD/CAM System employs<br>optical 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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| Product<br>Name | Mater<br>ial | Min post<br>height<br>mm | Max<br>angulati<br>on | Min<br>Gingiva<br>height<br>mm | Min wall<br>thickness<br>mm |
|----------------------|------------------|--------------------------|-----------------------|--------------------------------|-------------------------------------------|
| 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 HT<br>Preshade | ZrO2 | 4.0 | 30° | 1 | 0.6 |
| n!ce | Glass<br>ceramic | 4.0 | 30° | 1 | 1.05 |
| IPS e.max<br>CAD | Glass<br>ceramic | 4.0 | 30° | 1 | 0.75 to<br>pre-<br>molar<br>0.95<br>molar |

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 Level<br>Narrow CrossFit® (NC) | 37 mm2 to 56 mm2 dependent on tooth position | 30° | 0.4 | 0.87 |
| PMAB | TAN | Bone Level<br>Regular CrossFit® (RC) | This corresponds to a minimum height of ~4 mm | 30° | 0.4 | 0.87 |
| PMAB | TAN | Tissue Level<br>Regular Neck (RN) | | 30° | 0.4 | N/A |
| PMAB | TAN | Tissue Level<br>Wide 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 is<br>indicated for the design and fabrication of single or multiple-<br>unit implant-borne prosthetics for the restoration of partially or<br>fully edentulous mandibles and maxillae. The system<br>integrates multiple components of the digital dentistry<br>workflow: scan files from Intra-Oral Scanners or Extra-Oral<br>Scanners, CAD software, CAM software, restoration material<br>blanks, milling machines and associated tooling and<br>accessories. The system is used to design and fabricate<br>CAD/CAM milled coping, crown and bridge restorations to be<br>cemented onto Straumann® Variobase® Abutments, as well as<br>milled abutments to be affixed to the endosseous dental<br>implants of the Straumann® Dental Implant System using a<br>basal screw. |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The Straumann CARES M-Series CAD/CAM System is<br>intended to be used for the design and fabrication of patient-<br>specific dental restorations. The dental restorations are intended<br>to restore dental implants, either directly (CAD/CAM milled<br>abutment) or via a Ti-base style abutment (Straumann trade<br>name 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 Abutment<br>Blank | TAN (Ti6A7Nb) |
| Ceramill ZOLID fx<br>(Straumann brand<br>Zolid SHT) | ZrO2 (YSZ)- Yttria-<br>stabilized zirconia |
| Ceramill Zi<br>(Straumann brand<br>Zolid HT and Zi) | ZrO2 (YSZ) |
| IPS e.max CAD | Lithium-disilicate<br>glass-ceramic |
| n!ce | Lithium-<br>aluminosilicate with<br>Lithium-disilicate<br>glass-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 | SUBJECT<br>Straumann® CARES® M-Series<br>CAD/CAM System | PREDICATE<br>SIRONA DENTAL CAD/CAM<br>SYSTEM (K111421) | Equivalence<br>Discussion |
|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | The Straumann CARES M-Series<br>CAD/CAM System is indicated for the<br>design and fabrication of single or<br>multiple-unit implant-borne prosthetics for<br>the restoration of partially or fully<br>edentulous mandibles and maxillae. The<br>system integrates multiple components of<br>the digital dentistry workflow: scan files<br>from Intra-Oral Scanners or Extra-Oral<br>Scanners, CAD software, CAM software,<br>restoration material blanks, milling<br>machines and associated tooling and<br>accessories. The system is used to design<br>and fabricate CAD/CAM milled coping,<br>crown and bridge restorations to be<br>cemented onto Straumann® Variobase®<br>Abutments, as well as milled abutments to<br>be affixed to the endosseous dental<br>implants of the Straumann® Dental<br>Implant System using a basal screw. | The Sirona Dental CAD/CAM System is<br>intended for use in partially or fully<br>edentulous mandibles and maxillae in<br>support of single or multiple-unit cement<br>retained restorations. For the titanium<br>bases SSO 3.5 Land SBL 3.3 L, the<br>indication is restricted for replacement of<br>single lateral incisors in the maxilla and<br>lateral and central incisors in the mandible.<br>The system consists of three major parts:<br>TiBase, inCoris mesostructure, and<br>CAD/CAM software. Specifically, the<br>inCoris mesostructure and TiBase<br>components make up a two-piece<br>abutment which is used in conjunction<br>with endosseous dental implants to restore<br>the function and aesthetics in the oral<br>cavity. The inCoris mesostructure may<br>also be used in conjunction with the<br>Camlog Titanium base CAD/CAM (types<br>K2244.xxxx) (K083496) in the Camlog<br>Implant System. The CAD/CAM software<br>is intended to design and fabricate the<br>inCoris mesostructure.<br>The inCoris mesostructure and TiBase<br>two-piece abutment is compatible with the<br>following implants systems:<br>• Nobel Biocare Replace (K020646)<br>• Nobel Biocare Branemark (K022562)<br>· Friadent Xive (K013867)<br>· Biomet 3i Osseotite (K980549)<br>• Astra Tech Osseospeed (K091239)<br>· Zimmer Tapered Screw-Vent (K061410)<br>· Straumann SynOcta (K061176) | Equivalent<br>The basic indication of providing support<br>for prostheses scanning, design and<br>fabrication is the same.<br>Support for TiBase-borne restorations is<br>the same. The subject device indications<br>refer to fabrication of coping, crowns and<br>bridges. The proposed copings, crowns<br>and bridges include the mesostructure (or<br>top-half of two-piece abutment), which are<br>the same as referenced in the primary<br>predicate indications. The crowns and<br>bridges of the subject device may be<br>referred to as hybrid abutments and are<br>therefore equivalent.<br>The subject device also supports the<br>fabrication of implant connected solid<br>abutments. |
| FEATURE | SUBJECT<br>Straumann® CARES® M-Series<br>CAD/CAM System | PREDICATE<br>SIRONA DENTAL CAD/CAM<br>SYSTEM (K111421) | Equivalence<br>Discussion |
| | | • Straumann Bone Level (K053088,<br>K062129, K060958)<br>• Biomet 3i Certain (K014235, K061629)<br>• Nobel Biocare Active (K071370) | |
| Source of Input<br>Files | Intra-Oral Scanner<br>Bench-top Scanners | Bench-top scanners | Equivalent<br>Capabilities of subject device include the<br>scope of capabilities for the predicate<br>device. |
| Bench Scanner<br>Control | Yes | Yes | Equivalent |
| Implant Detection | Yes, using Scanbodies | Yes, using Scanbodies | Equivalent |
| Design Environment | Straumann CARES Visual:<br>Closed CAD System facilitating the design<br>of restorations used in conjunction with the<br>devices of the Straumann Dental Implant<br>System (SDIS). | Sirona Dental CAC/CAM Software<br>Closed CAD System facilitating the design<br>of restorations used in conjunction with the<br>Sirona TiBase devices and Camlog<br>Titanium Base CAD/CAM devices. | Equivalent<br>Both systems support the design and<br>fabrication of device-borne restorations,<br>but for devices from different companies. |
| Restoration Types<br>Supported | Device-borne:<br>Copings and crowns for Variobase<br>Abutments<br>Copings, crowns and bridges for Screw-<br>Retained Abutments<br>Bridges and bars for Variobase for<br>Bridge/Bar Abutments<br>Solid TAN Abutments for Straumann<br>Implants | Device-borne:<br>Copings and crowns for TiBase devices<br>Copings and crowns for Camlog Titanium<br>Base devices | Equivalent<br>Capabilities of subject device include the<br>scope of capabilities for the predicate<br>device. Both devices allow design and<br>fabrication of the mesostructure for a two-<br>piece abutment (standard coping or hybrid<br>crown/bridge). The subject device also<br>allows design and fabrication of a one-<br>piece titanium abutment. The areas of the<br>abutment available for design are<br>equivalent. |
| Supported<br>Hardware Devices | • Straumann Variobase Abutments for<br>NC, RC, NNC, RN and WN implant-to-<br>abutment interfaces (K120822).<br>• Straumann Variobase Abutments for<br>Bridges and Bars for NC, RC, NNC, RN | • Sirona Ti-bases for use with the<br>following implant systems:<br>• Nobel Biocare Replace (K020646)<br>• Nobel Biocare Branemark (K022562)<br>• Friadent Xive (K013867)<br>• Biomet 3i Osseotite (K980549)<br>• Astra Tech Osseospeed (K091239) | Equivalent<br>Capabilities of subject device include the<br>scope of capabilities for the predicate<br>device related to support for titanium base<br>style abutments. The subject devices |
| FEATURE | SUBJECT<br>Straumann® CARES® M-Series<br>CAD/CAM System | PREDICATE<br>SIRONA DENTAL CAD/CAM<br>SYSTEM (K111421) | Equivalence<br>Discussion |
| | and WN implant-to-abutment interfaces<br>(K151157)<br>• Copings for Straumann Screw-Retained<br>Abutments (K133421).<br>• Solid abutments for connection with<br>NC, RC, RN and WN implants of the<br>SDIS using the subject Pre-Milled<br>Abutment Blanks. | • Zimmer Tapered Screw-Vent<br>(K061410)<br>• Straumann SynOcta (K061176)<br>• Straumann Bone Level (K053088,<br>K062129, K060958)<br>• Biomet 3i Certain (K014235,<br>K061629)<br>• Nobel Biocare Active (K071370)<br>• Camlog Titanium Base CAD/CAM | provide support for implant connected<br>abutments. |
| Supported<br>Restorative<br>Materials | • Ceramill ZOLID fx ZrO2<br>• Ceramill ZI ZrO2<br>• Ceramill ZOLID ZrO2<br>• Titanium-6Aluminum-7Niobium alloy<br>or TAN (Subject Pre-Milled Abutment<br>Blanks)<br>• Ivoclar IPS e.max CAD<br>• Straumann n!ce Glass Ceramic | • InCoris pre-sintered Ceramic (K062509)<br>ZrO2 | Equivalent<br>ZrO2 Ceramic material with indications<br>according to ISO 6872 Classification are<br>equivalent. The ZrO2 materials for use<br>with the Straumann CARES M-Series<br>CAD/CAM System have been previously<br>cleared by FDA.<br>The TAN material is identical to material<br>used in CARES TAN Abutments cleared<br>to market per K150899.<br>Straumann n!ce Blocks for Amann<br>Girrbach were previously cleared per<br>K170420.<br>The use of the Ivoclar IPS e.max CAD<br>material with Variobase Abutments has<br>been cleared per K142890.<br>The use of the n!ce material with<br>Variobase Abutments has been cleared per<br>K170354. |
| Restoration Sizes | Device-borne:<br>Single crown up to 16-Unit bridge | Device-borne:<br>Single crown | Equivalent<br>Capabilities of subject device include the<br>scope of capabilities for the predicate<br>device.<br>Support of bridges through two or more<br>implants is achieved through Variobase for |
| FEATURE | SUBJECT<br>Straumann® CARES® M-Series<br>CAD/CAM System | PREDICATE<br>SIRONA DENTAL CAD/CAM<br>SYSTEM (K111421) | Equivalence<br>Discussion |
| Interface to Ti-Base | Milled by the system using solid<br>restoration material discs or C14 blocks | Pre-milled in the A14 block material | Bridge/Bar abutments (K151157). Use of<br>multiple implants in the bridge limit the<br>force on the individual implant to be less<br>or equivalent to that of the single crown.<br>For a 16-unit bridge, the force is spread<br>over 4 or more implants.<br>Equivalent<br>The ability of the subject device to use<br>solid blocks provides greater design<br>flexibility to the user. |
| CAD to CAM<br>Transfer | Seamless, same software interface | Seamless, same software interface | Equivalent |
| CAM Capability | Nesting of multiple designs to maximise<br>use of material discs<br>Selection of tools, tool paths, speeds and<br>feed rates that the mill uses to produce an<br>accurate restoration<br>Encryption of milling file | Selection of tools, tool paths, speeds and<br>feed rates that the mill uses to produce an<br>accurate restoration…