Straumann Variobase Abutments

K170354 · Institut Straumann AG · NHA · Jun 7, 2017 · Dental

Device Facts

• Record ID: K170354
• Device Name: Straumann Variobase Abutments
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Jun 7, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

Device Story

Straumann Variobase Abutments (Ti-bases) serve as interface between Straumann dental implants and customized prosthetic restorations (copings/crowns). System utilizes titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb) base and basal screw. Dental laboratory technicians design restorations via wax-up or CAD; digitally designed components are manufactured at validated Straumann milling centers. Subject device expands material compatibility to include n!ce Glass Ceramic (lithium disilicate reinforced lithium aluminosilicate glass-ceramic). Device used in dental clinics; operated by dental professionals. Output is a finished dental prosthesis providing functional and aesthetic tooth replacement. Benefits include standardized interface for customized restorations, supporting both single-tooth and bridge applications.

Clinical Evidence

No clinical data. Evidence consists of bench testing: dynamic fatigue testing per FDA guidance for endosseous dental implants/abutments, steam sterilization validation per ISO 17665, and biocompatibility data for n!ce Glass Ceramic (cytotoxicity per ISO 10993-5, extractables/leachables per ISO 10993-18) leveraged from K160262.

Technological Characteristics

Materials: Ti-6Al-7Nb (ASTM/ISO 5832-11) for abutment/screw; n!ce Glass Ceramic for coping/crown. Dimensions: 3.8–7.0 mm diameter, 3.5–4.5 mm height. Max angulation: 30°. Workflow: CAD/CAM or traditional wax-up. Sterilization: Steam (ISO 17665). Connectivity: None (standalone).

Indications for Use

Indicated for patients requiring screw-retained single tooth or cement-retained single tooth and bridge dental restorations supported by Straumann dental implants.

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 Variobase Abutments (K142890)

Reference Devices

• n!ce Glass Ceramic Blocks (K160262)
• CARES Variobase Abutments (K120822)

Submission Summary (Full Text)

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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the logo is an abstract symbol that resembles a stylized human figure.

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

June 7, 2017

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

Re: K170354

Trade/Device Name: Straumann® Variobase® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: May 8, 2017 Received: May 9, 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

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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 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.

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.

# Lori A. Wiggins -S6

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)

K170354

Device Name

Straumann® Variobase® Abutments

#### Indications for Use (Describe)

The Straumann® Variobase® Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann® Variobase® Abutments are indicated for screwretained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann® Variobase® Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

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 | K170354 |
|----|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 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<br>[phone] |
| | Prepared By &<br>Secondary Contact: | Christopher Klaczyk<br>Head of Regulatory Affairs & Compliance<br>Institut Straumann AG<br>[phone] |
| | Date Prepared: | June 01, 2017 |
| | Product Code(s): | NHA (21 CFR 872.3630) |
| | Device Class: | II<br>(21 CFR 872.3630) |
| | Classification Panel: | Dental |
| | Classification Name: | Endosseous dental implant abutment (21 CFR 872.3630) |
| | Common Name | Endosseous dental implant abutment |
| | Proprietary Name: | Straumann® Variobase® Abutments |
| | Predicate Device(s): | K142890, Straumann Variobase Abutments (Institut<br>Straumann) |
| | Reference Device(s): | K160262, n!ce Glass Ceramic Blocks (Institut Straumann)<br>K120822, CARES Variobase Abutments (Institut Straumann) |
| | Device Description: | The purpose of the subject submission is to add the previously<br>cleared Straumann n!ce glass ceramic material (K160262) as a<br>cleared material suitable for fabrication of the coping or crown<br>that, when bonded to the previously cleared Variobase<br>abutment base (K142890), forms a finished dental prosthesis. |
| | | The Straumann Variobase Abutments are pre-manufactured<br>(stock) abutments, sometimes referred to as "Ti-bases".<br>Straumann Variobase Abutments are available to fit Straumann<br>dental implant platforms NNC (Narrow Neck CrossFit®), RN<br>(Regular Neck), WN (Wide Neck), NC (Narrow CrossFit), and |

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RC (Regular CrossFit). A dental laboratory technician would design the corresponding coping and/or crown (the second component of the Variobase two-piece abutment) and/or prosthetic restoration in the dental laboratory via their preferred workflow. The coping and/or crown would be manufactured via traditional laboratory methods for pressing or casting, or via validated Straumann milling.

## Picture of Device

Image /page/4/Figure/3 description: The image shows two dental implant models with labels. The model on the left is a cross-section of a dental implant with the "Basal Screw", "Prosthetic restoration (Full contour crown)", and "Straumann® Variobase Abutment" labeled with green arrows. The model on the right shows the parts of the dental implant separated from each other.

Indications For Use: The Straumann Variobase Abutment is a titanium base placed onto Straumann dental implants to provide support for customized prosthetic restorations. Straumann Variobase Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations. All digitally designed copings and/or crowns for use with the Straumann Variobase Abutment system are intended to be sent to Straumann for manufacture at a validated milling center.

- Materials: • Straumann Variobase Abutments: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The Ti-base components of the Straumann® Variobase™ Abutments are identical to the Ti-base components of the Straumann predicates (K142890).
- Straumann Basal Screw: Titanium-6 aluminum-7 niobium alloy (Ti-6Al-7Nb, TAN). The basal screw components of the Straumann® Variobase™ Abutments are identical to the basal screw components of the Straumann predicates (K142890).
- · Coping or Crown: n!ce Glass Ceramic (lithium disilicate reinforced lithium aluminosilicate glass-ceramic). The material is identical to the material of the Straumann reference devices (K160262).

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| Technological<br>Characteristics: | A comparison of the relevant technological characteristics<br>between the subject and primary predicate devices is provided<br>in the table that follows. |
|-----------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Data: | The material used in the manufacture of Straumann Variobase<br>Abutments is a titanium-aluminum-niobium alloy which meets<br>the requirements of ISO 5832-11. Bench testing was performed<br>to evaluate the performance of the proposed Straumann®<br>Variobase™ Abutments.<br>Dynamic fatigue tests were conducted in according to the<br>FDA guidance document "Guidance for Industry and FDA<br>Staff – Class II Special Controls Guidance Document: Root-<br>form Endosseous Dental Implants and Endosseous Dental<br>Abutments". Steam sterilization validation per FDA guidance entitled<br>Reprocessing Medical Devices in Health Care Settings:<br>Validation Methods and Labeling dated March 17, 2015 and<br>the ISO 17665 series standards. Biocompatibility of the Straumann n!ce Glass Ceramic was<br>established per K160262 based upon a cytotoxicity study per<br>ISO 10993-5 and an inorganic extractables/leachables study<br>per ISO 10993-18. Software validation per FDA guidance document: General<br>Principles of Software Validation; Final Guidance for<br>Industry and FDA Staff, issued on: January 11, 2002 and per<br>IEC 62304. No animal or human clinical studies were conducted. |
| Conclusions: | Based upon our assessment of the design and applicable<br>performance data, the subject devices have been determined to<br>be substantially equivalent to the identified predicate devices. |

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| Feature | SUBJECT Devices<br>Straumann Variobase Abutments | Primary PREDICATE Device<br>Straumann Variobase Abutments<br>(K142890) | Equivalence Discussion |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Straumann® Variobase™ Abutment is a<br>titanium base placed onto Straumann dental<br>implants to provide support for customized<br>prosthetic restorations. Straumann®<br>Variobase™ Abutments are indicated for<br>screw-retained single tooth or cement-<br>retained single tooth and bridge<br>restorations. | The Straumann® Variobase™ Abutment is a<br>titanium base placed onto Straumann dental<br>implants to provide support for customized<br>prosthetic restorations. Straumann®<br>Variobase™ Abutments are indicated for<br>screw-retained single tooth or cement-<br>retained single tooth and bridge<br>restorations. | Identical |
| Ti-base<br>Material | Titanium-Aluminum-Niobium alloy<br>(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium alloy<br>(Ti-6Al-7Nb) | Identical |
| Abutment<br>Diameter | 3.8 – 7.0 mm | 3.8 – 7.0 mm | Identical |
| Abutment Height | 3.5 – 4.5 mm | 3.5 – 4.5 mm | Identical |
| Max. Angulation | 30° | 30° | Identical |
| Coping/ Crown<br>Material | Straumann n!ce Glass Ceramic is being<br>added to the previously cleared<br>coping/crown materials | Traditional Workflow:<br>Type 4 Metals (ISO 22674)<br>IPS e.max® Press Ceramic<br>Digital Workflow:<br>polycon® ae (temporary)<br>zerion® (permanent)<br>IPS e.max® CAD Ceramic (permanent)<br>coron® (permanent) | Equivalent<br>The digital workflow is being expanded to<br>add an additional material, Straumann n!ce<br>glass ceramic.<br>Straumann n!ce glass ceramic was shown to<br>be substantially equivalent to IPS e.max<br>CAD per K160262 cleared on September<br>16, 2016. |
| Design Workflow | Wax-up or CAD | Wax-up or CAD | Identical |
| Feature | SUBJECT Devices<br>Straumann Variobase Abutments | Primary PREDICATE Device<br>Straumann Variobase Abutments<br>(K142890) | Equivalence Discussion |
| Manufacturing<br>Workflow | Straumann Milling | Traditional casting or pressing<br>Or<br>Straumann Milling | Identical |
| Mode of<br>Attachment | Screw-retained or cement retained | Screw-retained or cement retained | Identical |
| Reusable | No | No | Identical |

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