Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases

K180564 · Medentika GmbH · NHA · Jan 7, 2019 · Dental

Device Facts

• Record ID: K180564
• Device Name: Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases
• Applicant: Medentika GmbH
• Product Code: NHA · Dental
• Decision Date: Jan 7, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient. Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Device Story

Medentika Multi-Platform System consists of metallic endosseous dental implant abutments and prosthetic superstructures; includes stock abutments, CAD/CAM abutments, and TiBases. Used to support cement-retained, screw-retained, or overdenture prostheses. Stock abutments fabricated from titanium-aluminum-vanadium (TAV) and noble metal alloys; CAD/CAM abutments from commercially pure titanium; TiBase copings/crowns from zerion and IPS e.max CAD. System compatible with various third-party implant systems. Subject of submission is updated labeling for MR Conditional safety parameters. No changes to device design, materials, or manufacturing. Clinicians use these components to restore dental implants. MRI safety testing performed per ASTM standards to define safe scanning conditions (1.5T/3T fields, SAR limits) to prevent excessive heating or displacement in MR environment.

Clinical Evidence

No clinical data. Bench testing only. Evaluated MR safety per FDA guidance (2014/2015) and ASTM standards: ASTM F2052-15 (displacement force), ASTM F2213-06 (torque), ASTM F2182-11a (RF-induced heating), and ASTM F2119-13 (image artifacts). Results confirm MR Conditional status under specified 1.5T/3T scan conditions.

Technological Characteristics

Metallic endosseous dental implant abutments. Materials: TAV alloy, noble metal alloys, commercially pure titanium, zerion, IPS e.max CAD. Designs include single/multiple tooth support, angled (up to 21°), and two-piece TiBase configurations. Compatible with multiple implant platforms (Nobel Biocare, Biomet 3i, Straumann, Zimmer, Astra Tech, Dentsply Friadent). Sterilization and manufacturing processes unchanged from predicates.

Indications for Use

Indicated for use with dental implants as support for single or multiple tooth prostheses in maxilla or mandible of partially or fully edentulous patients.

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

• Medentika CAD/CAM TiBases (K170838)
• Medentika CAD/CAM Abutments (K150203)
• Medentika Abutment System (K142167)

Submission Summary (Full Text)

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

January 7, 2019

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

Re: K180564

Trade/Device Name: Medentika Abutment System Medentika CAD/CAM Abutments Medentika CAD/CAM TiBases Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 5, 2018 Received: October 9, 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/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) K180564

Device Name Medentika Abutment System

#### Indications for Use (Describe)

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

| Implant System | Series | Implant Diameters (mm) |
|--------------------------------|-----------|-------------------------|
| Nobel Biocare Replace Select | E -Series | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive | F -Series | 3.5, 4.3, 5.0 |
| Biomet 3i Osseotite® Certain | H -Series | 3.25, 4.0, 5.0 |
| Biomet 3i Osseotite | I -Series | 3.25, 3.75, 4.0, 5.0 |
| Nobel Biocare Branemark | K-Series | 3.3, 3.75, 4.0, 5.0 |
| Straumann Bone Level | L-Series | 3.3, 4.1, 4.8 |
| Straumann Standard | N -Series | 3.3, 4.1, 4.8 |
| Zimmer Tapered Screw-vent | R-Series | 3.3, 3.7, 4.1, 4.7, 6.0 |
| Astra Tech OsseoSpeed | S -Series | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T-Series | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y-Series | 3.5, 4.5, 5.5, 7.0 |

Abutments are compatible with the following implant systems:

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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### Indications for Use

510(k) Number (if known) K180564

Device Name Medentika CAD/CAM Abutments

#### Indications for Use (Describe)

Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

| Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|----------------------------------|--------|-------------------------|--------------------------------|
| Nobel Biocare Replace™ Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive™ | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) |
| Biomet 3i Osseotite® Certain® | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Biomet 3i Osseotite® | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Nobel Biocare Brånemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5(NNC), 4.8, 6.5 |
| Zimmer Tapered Screw-vent® | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Astra Tech OsseoSpeed™ | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent® Frialit/XiVE® | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |

Medentika PreFace is intended for use with the Straumann CARES System. All digitally designed abutments for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann CARES validated milling center.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> <svg height="12" width="12"> <rect fill="lightgray" height="12" width="12"></rect> <path d="M2,2 L10,10 M2,10 L10,2" stroke="black"></path> </svg> </span> </div> |
|----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> <svg height="12" width="12"> <rect fill="lightgray" height="12" width="12"></rect> </svg> </span> </div> |

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

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### Indications for Use

510(k) Number (if known) K180564

Device Name Medentika CAD/CAM TiBases

#### Indications for Use (Describe)

Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

| Implant System Compatibility | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|------------------------------------------------|--------|-------------------------|---------------------------|
| Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Dentsply®Implants/ASTRA TECH<br>OsseoSpeed® EV | EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 |
| Nobel Biocare NobelActive | F | 3.5, 4.3, 5.0 | 3.5, 3.9 (4.3), 3.9 (5.0) |
| Biomet 3i Osseotite Certain | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Biomet 3i Osseotite | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Nobel Biocare Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 |
| Straumann/ Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann / Soft Tissue Level | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 |
| Zimmer Tapered Screw-vent | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Astra Tech OsseoSpeed | S | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/XiVE | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 |

Medentika TiBase is intended for use with the Straumann CARES System.

All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.

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

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

#### 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:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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K180564 – MRI Safety Information Labeling Change

510(k) Summary

#### 510(k) Summary 5

#### Submitter 5.1

Straumann USA, LLC (on behalf of Medentika GmbH) 60 Minuteman Road Andover, MA 01810 Phone Number: [phone] Fax Number: [phone] Contact Person: Jennifer M. Jackson, MS Director, Regulatory Affairs Prepared By: Christopher Klaczyk Date of Submission: January 7, 2019 Device Trade Name: Medentika Abutment System Medentika CAD/CAM Abutments Medentika CAD/CAM TiBases Common Name: Endosseous Dental Implant Abutment Classification Name: Endosseous Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: ll Product Code: NHA

### 5.2 Predicate Device

| Predicate Devices: | K170838 – Medentika CAD/CAM TiBases |
|--------------------|---------------------------------------|
| | K150203 – Medentika CAD/CAM Abutments |
| | K142167 - Medentika Abutment System |

Reference Predicate: None

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### K180564 – MRI Safety Information Labeling Change

510(k) Summary

### 5.3 Device Description

The subject devices comprise the metallic endosseous dental implant abutments and metallic prosthetic superstructures cleared to market in the United States as of December 15, 2017 under K170838, K150203, and K142167 by Medentika GmbH as part of the Medentika Multi-Platform System.

Medentika Multi-Platform System is an abutment system including eleven abutment designs compatible with twelve currently marketed implant systems. The abutment designs include abutments for single-tooth and multiple-tooth restoration for supporting cement-retained, screw-retained or overdenture prostheses. Platform diameters range from 3.3 mm to 7.0 mm. Corresponding implant diameters range from 3.25 mm to 7.0 mm. Angled abutment designs for connections with anti-rotational features are available in two orientations, Type 1 and Type 2. Type 1 is for abutments with the cone angle oriented toward the flat of the anti-rotational feature and Type 2 is for abutments with the cone angle oriented toward the corner or lobe of the anti-rotational feature. The maximum angle for any abutment within the eleven systems is 21°.

The TiBases are titanium bases to be used as the lower part of two-piece abutments. The upper part of the two-piece abutment is a CAD/CAM designed and manufactured restoration. The TiBases are provided in several models and dimensions, according to the compatible implant systems declared in the Indications for Use statement.

The assessment of these devices in the MR environment has not resulted in any changes to the devices themselves. The proposed labeling change provides the parameters under which a patient having a restoration constructed using the devices of the Medentika Multi-Platform System can safely undergo an MRI scan.

The stock endossoues dental implant abutments are fabricated from titanium-aluminumvanadium (TAV) alloy and noble metal alloys. The CADCAM abutments are fabricated from commercially pure titanium. The materials for the TiBase copings and/or crowns include zerion and IPS e.max CAD.

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### K180564 – MRI Safety Information Labeling Change

510(k) Summary

#### 5.4 Indications for Use

#### Medentika Abutment System

Medentika abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

Abutments are compatible with the following implant systems:

| Implant System | Series | Implant Diameter (mm) |
|--------------------------------|-----------|-------------------------|
| Nobel Biocare Replace Select | E -Series | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive | F -Series | 3.5, 4.3, 5.0 |
| Biomet 3i Osseotite® Certain | H -Series | 3.25, 4.0, 5.0 |
| Biomet 3i Osseotite | I -Series | 3.25, 3.75, 4.0, 5.0 |
| Nobel Biocare Branemark | K -Series | 3.3, 3.75, 4.0, 5.0 |
| Straumann Bone Level | L -Series | 3.3, 4.1, 4.8 |
| Straumann Standard | N -Series | 3.3, 4.1, 4.8 |
| Zimmer Tapered Screw-vent | R -Series | 3.3, 3.7, 4.1, 4.7, 6.0 |
| Astra Tech OsseoSpeed | S -Series | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T -Series | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y -Series | 3.5, 4.5, 5.5, 7.0 |

### Medentika CAD/CAM Abutments

Medentika Preface CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

| Implant System | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|--------------------------------|--------|-------------------------|--------------------------------|
| Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Nobel Biocare NobelActive | F | 3.0, 3.5, 4.3, 5.0 | 3.0, 3.5, 3.9 (4.3), 3.9 (5.0) |
| Biomet 3i Osseotite® Certain | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Biomet 3i Osseotite | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Nobel Biocare Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 |
| Zimmer Tapered Screw-vent | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Astra Tech OsseoSpeed | S | 3.0, 3.5, 4.0, 4.5, 5.0 | 3.0, 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |

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## K180564 – MRI Safety Information Labeling Change

510(k) Summary

Medentika PreFace is intended for use with the Straumann CARES System. All digitally designed abutemtns for use with Medentika CAD/CAM Abutments are intended to be manufactured at a Straumann CARES validated milling center.

### Medentika CAD/CAM TiBases

Medentika TiBase CAD/CAM Abutments are intended for use with dental implants as a support for single or multiple tooth prostheses in the maxilla or mandible of a partially or fully edentulous patient.

| Implant System | Series | Implant Diameter (mm) | Platform Diameter (mm) |
|-----------------------------------------------|--------|-------------------------|---------------------------|
| Nobel Biocare Replace Select | E | 3.5, 4.3, 5.0, 6.0 | 3.5, 4.3, 5.0, 6.0 |
| Dentsply® Implants / AstraTech OsseoSpeed® EV | EV | 3.6, 4.2, 4.8, 5.4 | 3.6, 4.2, 4.8, 5.4 |
| Nobel Biocare NobelActive | F | 3.5, 4.3, 5.0 | 3.5, 3.9 (4.3), 3.9 (5.0) |
| Biomet 3i Osseotite® Certain | H | 3.25, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Biomet 3i Osseotite | I | 3.25, 3.75, 4.0, 5.0 | 3.4, 4.1, 5.0 |
| Nobel Biocare Branemark | K | 3.3, 3.75, 4.0, 5.0 | 3.5, 4.1, 4.1, 5.1 |
| Straumann Bone Level | L | 3.3, 4.1, 4.8 | 3.3, 4.1, 4.8 |
| Straumann Standard | N | 3.3, 4.1, 4.8 | 3.5 (NNC), 4.8, 6.5 |
| Zimmer Tapered Screw-vent | R | 3.3, 3.7, 4.1, 4.7, 6.0 | 3.5, 4.5, 5.7 |
| Astra Tech OsseoSpeed | S | 3.5, 4.0, 4.5, 5.0 | 3.5, 4.0, 4.5, 5.0 |
| Dentsply Friadent Frialit/Xive | T | 3.4, 3.8, 4.5, 5.5 | 3.4, 3.8, 4.5, 5.5 |
| Dentsply Friadent Ankylos | Y | 3.5, 4.5, 5.5, 7.0 | 3.5, 4.5, 5.5, 7.0 |

Medentika TiBase is intended for use with the Straumann CARES System.

All digitally designed copings and/or crowns are intended to be sent to Straumann for manufacture at a validated milling center.

#### Technoloqical Characteristics 5.5

The scope of this submission is the modification of the device labeling to include validated MRI Safety Information. The materials, processing, dimensions, packaging, sterilization, and labeling are all identical to those of the identified predicate devices. The indications for use of the subject devices are also identical to those of the identified predicate devices.

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### K180564 – MRI Safety Information Labeling Change

510(k) Summary

The intended use of the subject devices is expanded in that the devices are now identified as being MR Conditional.

### 5.6 Performance Data

The testing presented in this submission is consistent with the FDA Guidance entitled Establishing Safety and Compatibility of Passive Implants in the Magnetic Resonance (MR) Environment dated August, 2014 and the FDA Guidance document entitled Assessment of Radiofrequency-Induced Heating in the Magnetic Resonance (MR) Environment for Multi-Configuration Passive Medical Devices dated June 29, 2015. For the evaluation of displacement force, testing was conducted per the deflection angle test per ASTM F2052-15, Standard test method for measurement of magnetically induced displacement force on passive implants in the magnetic resonance environment.

For the evaluation of torsional force, testing was conducted per the procedure described by Shellock, et al. This method has been shown to be acceptable for the evaluation of torque for a metallic implant or device. According to ASTM F2213-06 (2011), Standard Test Method for Measurement of Magnetically Induced Torque on Passive Implants in the Magnetic Resonance Environment, such alternative methods are acceptable.

For the evaluation of RF-induced heating, testing was conducted per recommendations in ASTM F2182-11a. Standard Test Method for Measurement of Radio Frequency Induced Heating Near Passive Implants During Magnetic Resonance Imaging. For the evaluation of image artifacts, testing was conducted per ASTM F2119-13, Standard Test Method for Evaluation of MR Image Artifacts from Passive Implants.

### 5.7 Conclusion

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 and reference devices.

Based upon the proposed definition of the worst-case constructs incorporating metallic implantable devices, and the physical testing of same, we have defined the following text to be used for the MRI Safety Information section of the labeling:

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## K180564 – MRI Safety Information Labeling Change

510(k) Summary

Image /page/10/Picture/3 description: The image shows a black triangle with the letters "MR" in bold black font inside of it. Below the triangle, the words "MR Conditional" are written in a smaller, black font. The triangle is a simple, equilateral shape, and the text is centered below it.

Non-clinical testing and MRI simulations were performed to evaluate the dental implant abutment system offered by Medentika GmbH. Non-clinical testing demonstrates that these products are MR Conditional. A patient with an implant abutment from the Medentika Multi-Platform System can be scanned safely in an MR system under the following conditions:

- . Static magnetic field of 1.5 Tesla and 3 Tesla, only
- . Maximum spatial gradient magnetic field of 4,000 gauss/cm (40 T/m)
- Maximum MR system reported whole body averaged specific absorption rate . (SAR) of 2 W/kg and head average SAR of 3.2 W/kg, for 15 minutes of scanning (i.e., per pulse sequence) in the Normal Operating Mode

Under the scan conditions defined, the implant abutments from the Medentika Multi-Platform System are expected to produce a maximum temperature rise of 4.9℃ after 15-minutes of continuous scanning (i.e., per pulse sequence).

In non-clinical testing, the image artifact caused by the implant abutments from the Medentika Multi-Platform System extend approximately 10 mm from this device when imaged with a gradient echo pulse sequence and a 3 Tesla MR system