Straumann CARES Golden Ti/TiN Abutments

K162848 · Institut Straumann AG · NHA · Sep 22, 2017 · Dental

Device Facts

• Record ID: K162848
• Device Name: Straumann CARES Golden Ti/TiN Abutments
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Sep 22, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Indications for Use

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures. The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

Device Story

Patient-specific dental abutments; designed via traditional waxup/scanning or intraoral scanning; CAD software used for design; design data transmitted via internet portal to manufacturer; manufacturer verifies design against parameters (max 30° angulation, minimum surface area requirements). Manufactured from solid grade 4 titanium; emergence profile and coronal aspect coated with titanium nitride (TiN) for esthetics; implant-to-abutment interface masked during coating. Delivered to dental laboratory for final processing; attached to implant with titanium alloy basal screw; occlusal restoration affixed with dental cement. Used in dental clinics; operated by dental professionals. Benefits include improved esthetics of finished restoration while maintaining mechanical function of titanium abutment.

Clinical Evidence

Bench testing only. No clinical data. Testing included sterilization validation (ISO 17665-1/2), biocompatibility (ISO 10993-1/5/18), dynamic fatigue (ISO 14801), and coating characterization (composition, thickness, porosity, SEM). Adhesion testing performed per ASTM F1044 and F1160. Abrasion testing performed per Tamura et al. methodology.

Technological Characteristics

Substrate: Commercially pure grade 4 titanium (ISO 5832-2). Surface: Titanium nitride (TiN) coating on emergence profile and coronal aspect. Interface: Masked/uncoated. Form factor: One-piece solid abutment. Sterilization: Moist heat (autoclave) to SAL 10^-6. Connectivity: Internet portal for design submission.

Indications for Use

Indicated for patients requiring single tooth replacements or multiple tooth restorations supported by dental implants. Prosthetic restorations must be cement-retained.

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 WN Ti Abutments (K082764)

Reference Devices

• Straumann CARES RN Ti Abutments (K052272)
• Straumann CARES RC Ti Abutments (K072151)
• Straumann CARES NC Ti Abutments (K081005)
• 3i TiN Coated Implants and Abutments (K992334)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 22, 2017

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

Re: K162848

Trade/Device Name: Straumann® CARES® Golden Ti/TiN Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: August 25, 2017 Received: August 28, 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.

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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Mary S. Runner -S

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)

## K162848

Device Name

Straumann® CARES® Golden Ti/TiN Abutments

Indications for Use (Describe)

Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.

The Straumann CARES Golden TiTiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

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

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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| 5. | 510(k) Summary | K162848 |
|----|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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, Regulatory Affairs and Quality<br>[phone] |
| | Prepared By &<br>Secondary Contact: | Christopher Klaczyk<br>Head of Regulatory Affairs & Compliance<br>Institut Straumann AG<br>[phone] |
| | Date Prepared: | September 22, 2017 |
| | Product Code(s): | NHA (21 CFR 872.3630) |
| | Device Class: | II (21 CFR 872.3630) |
| | Classification Panel: | Dental |
| | Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| | Proprietary Name: | Straumann® CARES® Golden Ti/TiN Abutment |
| | Primary Predicate<br>Device: | K082764, Straumann CARES WN Ti Abutments (Institut Straumann) |
| | Reference Device(s): | K052272, Straumann CARES RN Ti Abutments (Institut Straumann)<br>K072151, Straumann CARES RC Ti Abutments (Institut Straumann)<br>K081005, Straumann CARES NC Ti Abutments (Institut Straumann)<br>K992334, 3i TiN Coated Implants and Abutments (Implants Innovations, Incorporated (3i)) |
| | Device Description: | The previously cleared Straumann CARES Titanium<br>Abutments are placed onto dental implants to support prosthetic<br>reconstructions such as crowns and bridges. The abutment<br>allows for individual customization regarding function and<br>esthetics. The design step is typically performed by the dental<br>laboratory to the specifications from a clinician. The abutments<br>are produced by a Straumann Manufacturing milling center. |

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The patient-specific abutment is designed by a traditional waxup and subsequent scanning or by scanning of the intraoral setting and designing the element via CAD software. The design information is sent via an Internet portal to Straumann. Straumann verifies the design against the validated design parameters. These design limits include a maximum angulation of 30° and a minimum surface area as follows:

| Tooth Position | Minimum surface area mm² |
|-------------------------|--------------------------|
| 7,10, 24,25 | 37 |
| 4,5,12,13,20,21,28,29 | 47 |
| 26,11,2,27,8,9 | 43 |
| 1-3, 14-16, 17-19,30-32 | 56 |

The abutments are manufactured from solid grade 4 titanium at the Straumann milling center. The abutment is delivered to the dental laboratory for final processing before delivery to the clinician. The abutments are attached to the implant with a titanium alloy basal screw. The occlusal restoration is affixed to the titanium abutment using dental cement.

The proposed devices are a modification of the previously licensed devices. The titanium abutments that serve as the base of the CARES Golden Ti/TiN Abutments (the uncoated abutments) are identical in every respect to the reference devices. The modification consists of the addition of a titanium nitride (TiN) coating on the emergence profile and coronal aspect of the abutment. The apical portion of the abutment consisting of the implant-to-abutment interface is masked during the coating process to assure that the interface remains uncoated.

Indications For Use: Abutments are placed into the dental implants to provide support for prosthetic restoration such as crowns, bridges or overdentures.

> The Straumann CARES Golden Ti/TiN Abutments are indicated for single tooth replacements and multiple tooth restorations. The prosthetic restoration is cement-retained.

- Materials: The substrate material for all Straumann CARES Golden Ti/TiN Abutments is commercially pure Titanium (grade 4) conforming to ISO 5832-2. The surface of the emergence profile and coronal aspect of the abutments are coated with titanium nitride (TiN). The implant-to-abutment interface is masked and remains uncoated.

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| Technological Characteristics: | A comparison of the relevant technological characteristics between the subject and primary predicate devices is provided in the table that follows. |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | Test data to support the evaluation of the subject Straumann CARES Golden Ti/TiN abutments is as follows:<br>Sterilization validation in accordance with ISO 17665-1 and ISO/TS 17665-2 Biocompatibility assessment per ISO 10993-1 Cytotoxicity testing per ISO 10993-5 Chemical characterization per ISO 10993-18 Dynamic fatigue testing per ISO 14801 by reference to K052272, K072151, K081005 and K082764 Coating characterization including chemical composition, thickness, porosity, mean volume percent voids, SEM images at 100X Adhesion testing by static shear bonding strength per ASTM F1044 employing minimum shear stress acceptance criteria per ASTM F2068 Adhesion testing by dynamic shear bonding strength per ASTM F1160 Abrasion testing consistent with the method described by Tamura, et al, entitled <i>Mechanical Properties of Surface Nitrided Titanium for Abrasion Resistant Implant Materials</i> . No animal or human clinical studies were conducted. |
| 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. |

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| Feature | Primary Predicate Devices<br>CARES Titanium Abutments<br>(K082764) | Subject Devices<br>CARES Titanium Gold Abutments | Equivalence<br>Discussion |
|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications For Use | Abutments are placed into the dental<br>implants to provide support for prosthetic<br>restoration such as crowns, bridges and<br>overdentures.<br><br>The Straumann Titanium Abutment is<br>indicated for single tooth replacements<br>and multiple tooth restorations. The<br>prosthetic restoration is cement-retained. | Abutments are placed into the dental<br>implants to provide support for prosthetic<br>restoration such as crowns, bridges or<br>overdentures.<br><br>The Straumann CARES Golden Ti/TiN<br>Abutment is indicated for single tooth<br>replacements and multiple tooth<br>restorations. The prosthetic restoration is<br>cement-retained. | Identical |
| Compatible Implants | Straumann Bone Level implants having<br>the NC and RC implant-to-abutment<br>interface geometries.<br><br>Straumann Tissue Level implants having<br>the NN, RN and WN implant-to-<br>abutment interface geometries. | Straumann Bone Level implants having<br>the NC and RC implant-to-abutment<br>interface geometries.<br><br>Straumann Tissue Level implants having<br>the NN, RN and WN implant-to-<br>abutment interface geometries. | Identical |
| Material | Commercially pure grade 4 Titanium<br>per ISO 5832-2 | Commercially pure grade 4 Titanium<br>per ISO 5832-2 | Identical |
| Surface Finish | Uncoated (raw titanium) | Titanium nitride (TiN) coating on<br>emergence profile and coronal surfaces | Equivalent<br>The TiN coating is being added to impart<br>gold color to the emergence profile and<br>coronal surfaces of the abutment in order<br>to improve the esthetics of the finished<br>restoration. The presence of the coating<br>does not change the intended uses or<br>indications of the devices. This use of<br>TiN coating was originally cleared to<br>market per K992334. |
| Construction | One-piece solid devices. | One-piece solid devices. | Identical |
| Feature | Primary Predicate Devices<br>CARES Titanium Abutments<br>(K082764) | Subject Devices<br>CARES Titanium Gold Abutments | Equivalence<br>Discussion |
| Design Limits: | Maximum Angulation: 30°<br>Minimum Surface Area:<br>Pos, 7,10, 24,25 37 mm²<br>Pos, 4,5,12,1320,21,28,29 47 mm²<br>Pos, 26,11,2,27,8,9 43 mm²<br>Pos, 1-3, 14-16, 17-19,30-32 56 mm² | Maximum Angulation: 30°<br>Minimum Surface Area:<br>Pos, 7,10, 24,25 37 mm²<br>Pos, 4,5,12,1320,21,28,29 47 mm²<br>Pos, 26,11,2,27,8,9 43 mm²<br>Pos, 1-3, 14-16, 17-19,30-32 56 mm² | Identical |
| Packaging | The abutment and basal screw in<br>reclosable poly bags, co-packaged in a<br>kraft board box. | The abutment and basal screw inkraft board box. | Identical |
| Sterility | Provided non-sterile.<br>Terminally sterilized via moist heat<br>(autoclave) to a Sterility Assurance Level<br>of 10-6. Validated per ISO 17665-1. | Provided non-sterile.<br>Terminally sterilized via moist heat<br>(autoclave) to a Sterility Assurance Level<br>of 10-6. Validated per ISO 17665-1. | Identical |

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