Straumann CARES Abutments CoCr

K172798 · Institut Straumann AG · NHA · Jan 3, 2018 · Dental

Device Facts

• Record ID: K172798
• Device Name: Straumann CARES Abutments CoCr
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Jan 3, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

Device Story

Straumann® CARES® Abutments CoCr are customized dental abutments for Straumann implant platforms (RN, WN, NC, RC). Dental laboratory technicians design the abutment using either a scanned conventional wax-up or intraoral scan data processed via Straumann-approved software (e.g., Straumann® CARES® Visual). Design data is transmitted to a central milling center for fabrication. The final CoCr abutment is delivered to the clinician, who may veneer it before screw-retaining or cementing the prosthetic restoration onto the implant. The device is used in a clinical setting by dental professionals to restore function and esthetics for patients requiring tooth replacement.

Clinical Evidence

No clinical data (animal or human) was provided. Substantial equivalence is supported by bench testing: dynamic fatigue testing per ISO 14801; biocompatibility testing per ISO 10993-5 and ISO 10993-18; corrosion resistance per ISO 10271; and metal-ceramic compatibility per ISO 9693-1. Sterilization validation was performed to an SAL of 10^-6.

Technological Characteristics

Customized abutment made of cobalt-chromium dental alloy (coron, ISO 22674 type 4) with a Titanium-6 aluminum-7 niobium (Ti-6Al-7Nb) basal screw. One-piece solid form factor. Provided non-sterile; user-sterilized via steam autoclave. Connectivity involves digital design data transfer to a central milling facility. Software-assisted design via Straumann® CARES® Visual.

Indications for Use

Indicated for single or multiple tooth replacement in patients requiring dental implant restorations. No specific age or gender contraindications provided.

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

• Straumann® CARES® Titanium Alloy (TAN) Abutments (K150899)

Reference Devices

• Straumann® CARES® SRBB (K132844)
• Straumann® CARES® Bridge, Straumann® CARES® Bar (K101465)
• Modified S/SP/BL 3.3 Implants (K083550)
• Medentika CAD/CAM Abutments (K150203)
• Small Diameter Implant (SDI) (K162890)
• Straumann Dental Implant System: P.004 Implants (K062129)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.

January 3, 2018

Institut Straumann AG % Jennifer Jackson Director, Regulatory Affairs Straumann USA, LLC 60 Minuteman Road Andover, Massachusetts 01801

Re: K172798

Trade/Device Name: Straumann® CARES® Abutments CoCr Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: December 4, 2017 Received: December 5, 2017

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.

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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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

## Andrew I. Steen -S

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K172798p here to enter text

Device Name

Straumann® CARES® Abutments CoCr

Indications for Use (Describe)

The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.

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

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 510(k) Summary<br>1. | 510(k) Number: K172798 |
|-------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315 Owner/Operator No.: 9005052 |
| Contact Person: | Jennifer M. Jackson, MS<br>Director of Regulatory Affairs and Quality<br>[phone] |
| Prepared By & Secondary<br>Contact: | Shokoufeh Khodabandeh<br>Regulatory Affairs and Compliance Manager<br>Institut Straumann AG<br>[phone] |
| Date Prepared: | January 3, 2018 |
| Product Code(s): | NHA |
| Device Class: | II |
| Classification Panel: | Dental |
| Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Common Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| Proprietary Name:<br>Predicate Device(s): | Straumann® CARES® Abutments CoCr<br>K150899 Straumann® CARES® Titanium Alloy (TAN) Abutments;<br>Manufacturer Straumann |
| Reference Device(s): | K132844Straumann® CARES® SRBB; Manufacturer Straumann<br>K101465 Straumann® CARES® Bridge, Straumann® CARES®<br>Bar ; Manufacturer Straumann<br>K083550 Modified S/SP/BL 3.3 Implants;Manufacturer Straumann<br>K150203 Medentika CAD/CAM Abutments; Manufacturer Medentika<br>Gmbh<br>K162890 Small Diameter Implant (SDI); Manufacturer Straumann<br>K062129 Straumann Dental Implant System: P.004 Implants;<br>Manufacturer Straumann |
| Device Description: | Straumann® CARES® Abutments CoCr are used for the restoration<br>of Straumann dental implant platforms RN (Regular Neck), WN<br>(Wide Neck), NC (Narrow CrossFit), and RC (Regular CrossFit). The<br>Straumann® CARES® Abutments CoCr allow for individual<br>customization regarding function and esthetics. Straumann®<br>CARES® Abutments CoCr are designed by the dental laboratory<br>technician either by means of a conventional wax-up model that is<br>subsequently scanned or by scanning the intraoral situation and<br>designing the shape by using a Straumann-approved software (such<br>as Straumann® CARES® Visual). The design data is then<br>transferred to a Straumann central milling center where the<br>fabrication of the customized abutment is carried out.<br>The Straumann® CARES® Abutments CoCr can be directly<br>veneered. |

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| Indications For Use: | The Straumann® CARES® Abutments CoCr are indicated for single tooth replacement and multiple tooth restorations. The prosthetic restoration can be cemented or directly veneered/screw-retained.. |
|--------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Materials: | Straumann CARES Abutments CoCr: cobalt-chromium based dental alloy, trade named coron. This material is identical to the coron material used in Straumann® CARES® SRBB (K132844 and K101465). Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw component of the Straumann® CARES® Abutments CoCr are identical to the basal screw components of the Straumann predicates (K150899, K041295, K071357, and K062129 ). |
| Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and the primary predicate is provided in the table that follows. |

| Feature | Subject Device<br>Straumann® CARES® Abutments<br>CoCr | Primary Predicate Devices<br>Straumann® CARES® Titanium<br>Alloy (TAN) Abutments<br>(K150899) | Equivalence<br>Discussion |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|
| Indication for<br>use | The Straumann® CARES®<br>Abutments CoCr are indicated for<br>single tooth replacement and<br>multiple tooth restorations. The<br>prosthetic restoration can be<br>cemented or directly<br>veneered/screw-retained. | The Straumann® CARES®<br>Abutments TAN are indicated for<br>single tooth replacement and<br>multiple tooth restorations. The<br>prosthetic restoration can be<br>cemented or directly<br>veneered/screw-retained. | Identical |
| Compatible<br>Implants | Straumann Bone Level implants<br>having the NC and RC implant-to-<br>abutment interface geometries.<br>Straumann Tissue Level implants<br>having the RN and WN implant-to-<br>abutment interface geometries. | Straumann Bone Level implants<br>having the NC and RC implant-to-<br>abutment interface geometries.<br>Straumann Tissue Level implants<br>having the NN, RN, WN implant-to-<br>abutment interface geometries. | Identical |
| Material | CARES abutment: Cobalt-chromium<br>Alloy (coron)<br>Basal screw: Titanium alloy<br>(Ti6Al7Nb), TAN | CARES abutment: Titanium alloy<br>(Ti6Al7Nb), TAN<br>Basal screw: Titanium alloy<br>(Ti6Al7Nb), TAN | Equivalent |

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| Feature | Subject Device<br>Straumann® CARES® Abutments<br>CoCr | Primary Predicate Devices<br>Straumann® CARES® Titanium<br>Alloy (TAN) Abutments<br>(K150899) | Equivalence<br>Discussion | | | | | | | | | | | | | | | | | | | | |
|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------|--|--|--|--|--|--|--|--|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|--|--|--|--|-----------|
| Design<br>Limits: | Max. Angulation 30°<br>Minimum thickness 0.33 mm Tooth Position Minimum<br>surface<br>area mm² 7,10, 24,25 37 4,5,12,1320,21,28,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-<br>19,30-32 56 | | | | | | | | | | | Max. Angulation 30°<br>Minimum thickness 0.33mm Tooth Position Minimum<br>surface<br>area mm² 7,10, 24,25 37 4,5,12,1320,21,2<br>8,29 47 26,11,2,27,8,9 43 1-3, 14-16, 17-<br>19,30-32 56 | | | | | | | | | | | Identical |
| Construction | One-piece solid Abutment supplied<br>with the compatible basal screw | One-piece solid abutment supplied<br>with the compatible basal screw | Identical | | | | | | | | | | | | | | | | | | | | |
| Packaging | The abutment in reclosable poly bag<br>and the corresponding basal screw is<br>individually packed in a blister,<br>co-packaged in a craft board box | The abutment in reclosable poly<br>bag and the corresponding basal<br>screw is individually packed in a<br>blister, co-packaged in a craft<br>board box. | Identical | | | | | | | | | | | | | | | | | | | | |
| Sterility | Provided non-sterile.<br>To be sterilized by the user in a<br>steam autoclave process. | Provided non-sterile.<br>To be sterilized by the user in a<br>steam autoclave process. | Identical | | | | | | | | | | | | | | | | | | | | |
| Fatigue<br>performance | Tested according to ISO 14801 | Tested according to ISO 14801 | Equivalent | | | | | | | | | | | | | | | | | | | | |

Performance Data: The material used in the manufacture of Straumann® CARES® Abutments CoCr is a cobalt-chromium alloy which meets the requirements of ISO 22674 type 4. Bench testing was performed to evaluate the performance of the proposed Straumann® CARES® Abutments CoCr. Dynamic fatigue tests were conducted according to the ISO 14801 "Dentistry - Implants - Dynamic fatigue test for endosseous dental implants" and 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 biocompatibility of the subject device is demonstrated by "Biological evaluation of

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medical devices - Part 1: Evaluation and testing within a risk management process", ISO 10993-5:2009 "Tests for in vitro cytotoxicity", and ISO 10993-18 "Chemical characterization of materials". Veneering performance testing of the Straumann CoCr alloy (coron) has been performed per ISO 9693-1, Dentistry – Compatibility testing – Part 1: Metal ceramic systems; A final workflow validation according to internal procedures has also been conducted. Corrosion resistance was demonstrated according to ISO 10271:2011 – "Corrosion test methods for metallic materials". Sterilization validation was carried out via the overkill method, 1/2 cycle, to a Sterilization Assurance Level (SAL) of 10-6 in accordance to the ANSI/AAMI/ISO 17665-1 and ANSI/AAMI/ISO 17665-2.

No animal or human clinical studies were conducted.

Conclusions: Based upon our assessment of the design and applicable performance data, the subiect devices have been determined to be substantially equivalent to the identified predicate devices.