NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges

K151157 · Straumann USA, LLC · NHA · Aug 5, 2015 · Dental

Device Facts

• Record ID: K151157
• Device Name: NC Straumann Variobase Abutment for Bars/Bridges, RC Straumann Variobase Abutment for Bars/Bridges, NNC Straumann Variobase Abutment for Bars/Bridges, RN Straumann Variobase Abutment for Bars/Bridges, WN Straumann Variobase Abutment for Bars/Bridges
• Applicant: Straumann USA, LLC
• Product Code: NHA · Dental
• Decision Date: Aug 5, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® Variobase® abutments are intended to be placed into Straumann dental implants to provide support for prosthetic reconstructions such as bridges and over-dentures.

Device Story

Straumann Variobase Abutments for Bridges/Bars are non-engaging titanium-6aluminum-7niobium (TAN) alloy components; they connect to endosseous dental implants to support multi-unit prosthetic reconstructions (bridges or over-dentures). Dental laboratory technicians design and manufacture the bridge/bar framework using traditional or CAD/CAM workflows. The abutment is secured to the implant via a basal screw. The device facilitates prosthetic rehabilitation by providing a stable interface for the restoration. Used in dental clinics by clinicians; the device benefits patients by enabling functional and aesthetic tooth replacement. The non-engaging design prevents mechanical constraints in multi-unit frameworks, ensuring proper fit.

Clinical Evidence

Bench testing only. Dynamic fatigue testing was performed in accordance with FDA guidance for Root-form Endosseous Dental Implants and Endosseous Dental Abutments and ISO 14801 standards to verify performance of the abutment design, including taller variants.

Technological Characteristics

Material: Titanium-6aluminum-7niobium (TAN) alloy. Design: Non-engaging Morse taper interface; 10° or 15° coronal conical taper. Dimensions: 4.2–7.0 mm diameter; 3.5–5.2 mm height. Connectivity: Mechanical interface to dental implant. Workflow: Compatible with traditional casting/pressing or CAD/CAM milling. Sterilization: Not specified (standard dental component).

Indications for Use

Indicated for use as an aid in prosthetic rehabilitations for patients requiring bridge or over-denture restorations on endosseous dental implants. Temporary restorations may be used during the healing phase to maintain, stabilize, and form soft tissue; these must not be placed into occlusion. Final abutments and restorations may be placed into occlusion once the implant is fully osseointegrated.

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

• Straumann Variobase Abutments (K132219)
• Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC (K120822)
• Straumann Bone Level Multibase Abutments (K080239)
• Straumann synOcta Prosthetics (K990342)
• Straumann Screw-Retained Bridge and Bar (K140737)

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

August 5, 2015

Straumann USA, LLC Mr. Christopher Klaczyk Director of Regulatory Affairs and Clinical Research 60 Minuteman Road Andover, Massachusetts 01810

Re: K151157

Trade/Device Name: Straumann® Variobase® Abutment for Bars/bridges Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: July 2, 2015 Received: July 6, 2015

Dear Mr. Klaczyk:

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 (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 yours,

Tina
Kiang-S

for Erin I. Keith, M.S. 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) K151157

Device Name

Straumann® Variobase Abutments for Bridges/Bars

#### Indications for Use (Describe)

Straumann® Variobase™ prosthetic components directly connected to the endosseous dental implants are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration (bridge or over-denture) can be cemented on the Straumann® Variobase™ prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the soft tissue during the healing phase. They may not be placed into occlusion. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

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

| <div> <span style="text-decoration: overline;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </div> |
|----------------------------------------------------------------------------------------------------------------|
| <div> <span style="text-decoration: overline;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </div> |

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# K151157

# 510(k) Summary

| Submitter: | Straumann USA, LLC (on behalf of Institut Straumann AG)<br>60 Minuteman Road<br>Andover, MA 01810<br>Registration No.: 1222315<br>Owner/Operator No.: 9005052 | | |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Christopher Klaczyk<br>Director of Regulatory Affairs and Clinical Research | | |
| Date Prepared: | August 4, 2015 | | |
| Product Code(s): | NHA (21 CFR 872.3630) | | |
| Device Class: | II<br>(21 CFR 872.3630) | | |
| Classification Panel: | Dental | | |
| Classification Name: | Endosseous dental abutment (21 CFR 872.3630) | | |
| Proprietary Name: | Straumann® Variobase® Abutment for Bridges/Bars | | |
| Predicate Device(s): | • K142890, Straumann Variobase Abutments | | |
| Reference Device(s): | • K132219, Straumann Variobase Abutments<br>• K120822, Straumann CARES Variobase Abutment NNC,<br>RN, WN, NC, RC<br>• K080239, Straumann Bone Level Multibase Abutments<br>• K990342, Straumann synOcta Prosthetics<br>• K140737, Straumann Screw-Retained Bridge and Bar | | |
| Device Description: | The Straumann Variobase Abutments for Bars & Bridges are<br>non-engaging abutments made from Ti-6Al-7Nb (TAN) that<br>support a bridge or bar reconstruction (framework or full<br>contour) on two or more dental implants. The corresponding<br>basal screw is delivered with the abutment for connecting the<br>abutment to the implant. A dental laboratory technician designs<br>and manufactures the bridge/bar reconstruction via their<br>preferred workflow using traditional or CAD/CAM methods. | | |

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| Indications For Use: | Straumann® Variobase® prosthetic components directly<br>connected to the endosseous dental implants are indicated for<br>use as an aid in prosthetic rehabilitations. The prosthetic<br>restoration (bridge or overdenture) can be cemented on the<br>Straumann® Variobase® prosthetic components. A temporary<br>restoration can be used prior to the insertion of the final<br>components to maintain, stabilize and form the soft tissue<br>during the healing phase. They may not be placed into<br>occlusion. Final abutments and restorations may be placed into<br>occlusion when the implant is fully osseointegrated. |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | Straumann® Variobase® abutments are intended to be placed<br>into Straumann dental implants to provide support for prosthetic<br>reconstructions such as bridges and over-dentures. |
| Materials: | The subject devices are produced from titanium-6aluminum-<br>7niobium alloy (TAN). This is the same material as for the<br>predicate devices cleared to market per premarket notification<br>submissions K120822, K132219 and K142890. |
| Technological<br>Characteristics: | The subject Straumann Variobase Abutments for Bridge/Bar<br>devices have the same Indications For Use, Implant-to-<br>Abutment platforms, materials, packaging and dynamic fatigue<br>performance as the identified Straumann Variobase Abutment<br>predicate devices. |
| | The subject devices differ in that they do not include the<br>engaging features of the implant-to-abutment interface design<br>allowing full axial rotation and the coronal aspect takes a form<br>better suited to multi-unit restorations. |

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| FEATURE | Straumann® Variobase®<br>Abutments for Bridges/Bars<br>Subject Submission | Primary Predicate<br>Straumann® Variobase®<br>Abutments<br>(K142890) | Reference Devices<br>Straumann® Multibase<br>(K080239) and synOcta<br>(K990342) Abutments | Equivalence<br>Discussion |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | Straumann® Variobase®<br>prosthetic components directly<br>connected to the endosseous<br>dental implants are indicated for<br>use as an aid in prosthetic<br>rehabilitations. The prosthetic<br>restoration (bridge or over-<br>denture) can be cemented on the<br>Straumann® Variobase®<br>prosthetic components. A<br>temporary restoration can be<br>used prior to the insertion of the<br>final components to maintain,<br>stabilize and form the soft tissue<br>during the healing phase. They<br>may not be placed into<br>occlusion. Final abutments and<br>restorations may be placed into<br>occlusion when the implant is<br>fully osseointegrated. | The Straumann® Variobase®<br>Abutment is a titanium base<br>placed onto Straumann dental<br>implants to provide support for<br>customized prosthetic<br>restorations. Straumann®<br>Variobase® Abutments are<br>indicated for screw-retained<br>single tooth or cement-retained<br>single tooth and bridge<br>restorations. | Not applicable | Equivalent<br>The basic indication of<br>providing support for prostheses<br>is identical. Where the predicate<br>is indicated for both single-unit<br>and multi-unit restorations, the<br>subject devices are only suitable<br>for multi-unit restorations. This<br>limited indication is within the<br>scope of the indication of the<br>predicate devices. |
| Abutment<br>Material | Titanium-Aluminum-Niobium<br>alloy (Ti-6Al-7Nb) | Titanium-Aluminum-Niobium<br>alloy (Ti-6Al-7Nb) | Not applicable | Identical |
| Abutment<br>Diameter | 4.2 - 7.0 mm | 3.8 - 7.0 mm | Not applicable | Equivalent<br>Subject device diameters are<br>within the range of diameters for<br>the predicate device. |
| FEATURE | Straumann® Variobase®<br>Abutments for Bridges/Bars<br>Subject Submission | Primary Predicate<br>Straumann® Variobase®<br>Abutments<br>(K142890) | Reference Devices<br>Straumann® Multibase<br>(K080239) and synOcta<br>(K990342) Abutments | Equivalence<br>Discussion |
| Abutment<br>Height | 3.5 – 5.2 mm | 3.5 – 4.5 mm | Not applicable | Equivalent<br>The subject devices have the<br>same minimum height as the<br>Variobase predicates.<br>Performance of the taller subject<br>device is addressed via bench<br>testing. |
| Abutment<br>Apical<br>Design | Non-engaging Morse taper | Engaging CrossFit® and Morse<br>taper | Not applicable | Equivalent<br>The Morse taper portion of both<br>the subject and Variobase<br>predicate devices are identical.<br>Non-engaging abutments are<br>necessary so as not to introduce<br>mechanical constraints in the<br>framework that would affect fit. |
| Abutment<br>Coronal<br>Design | 10° or15° conical taper | Straight wall with detents | 6° conical taper (K990342)<br>30° conical taper (K080239) | Equivalent<br>The conic taper of the subject<br>devices is within the range<br>established by the synOcta and<br>Multibase predicates. |
| FEATURE | Straumann® Variobase®<br>Abutments for Bridges/Bars<br>Subject Submission | Primary Predicate<br>Straumann® Variobase®<br>Abutments<br>(K142890) | Reference Devices<br>Straumann® Multibase<br>(K080239) and synOcta<br>(K990342) Abutments | Equivalence<br>Discussion |
| Restoration<br>Material | Materials cleared by the FDA<br>under 21 CFR 872.6660 or<br>exempt materials as described<br>under 21 CFR 872.3060 (Noble<br>metal alloys) and 21 CFR<br>872.3710 (Base metal alloys) | 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<br>(permanent)<br>coron® (permanent) | Not applicable | Equivalent<br>The range of materials cleared<br>for use with the predicate<br>devices is within the scope of<br>materials indicated for the<br>subject devices. |
| Design<br>Workflow | Wax-up or Open CAD<br>Exempt from pre-market<br>notification according to 21<br>CFR 807.85(a)(1). | Wax-up or Open CAD | Not applicable | Identical |
| Manufacturing<br>Workflow | Traditional casting, pressing or<br>Straumann Milling Center<br>Exempt from pre-market<br>notification according to 21<br>CFR 807.85(a)(1). | Traditional casting, pressing or<br>Straumann Milling Center | Not applicable | Identical |
| Mode of<br>Attachment | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Not applicable | Identical |
| Reusable | No | No | Not applicable | Identical |

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| Discussion of<br>Substantial<br>Equivalence: | The basic indication of providing support for prostheses is<br>identical. Where the predicate is indicated for both single-unit<br>and multi-unit restorations, the subject devices are only<br>suitable for multi-unit restorations. This limited indication is<br>within the scope of the indication of the predicate devices.<br>Subject device diameters are within the range of diameters for<br>the predicate devices. The subject devices have the same<br>minimum height as the Variobase predicates. |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Performance of the taller subject device is addressed via bench<br>testing. The Morse taper portion of both the subject and<br>Variobase predicate devices are identical. Non-engaging<br>abutments are necessary so as not to introduce mechanical<br>constraints in the framework that would affect fit. The conic<br>taper of the subject devices is within the range established by<br>the synOcta and Multibase predicates. The bonding surface<br>areas for the subject devices are consistent with those of the<br>predicate. The range of materials cleared for use with the<br>predicate devices is within the scope of materials indicated for<br>the subject devices. |
| Performance Data: | Per Guidance for Industry and FDA Staff - Class II Special<br>Controls Guidance Document: Root-form Endosseous Dental<br>Implants and Endosseous Dental Abutments dated May 12,<br>2004, the substantial equivalence of the subject device(s) are<br>satisfactorily addressed via bench studies. Dynamic fatigue test<br>data consistent with FDA guidance and ISO 14801 have been<br>referenced in support of this submission. |
| 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. |