Straumann SC Variobase Abutments

K173945 · Institut Straumann AG · NHA · Oct 5, 2018 · Dental

Device Facts

• Record ID: K173945
• Device Name: Straumann SC Variobase Abutments
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Oct 5, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® SC Variobase® Abutments are intended to be placed into Straumann® Bone Level Tapered Implants Ø2.9 mm to provide support for individual crowns or bridges.

Device Story

Two-piece dental abutment system consisting of titanium-alloy (TAN) base and digitally designed prosthetic restoration (coping/crown). Used in dental clinics by clinicians to support crowns or bridges on Straumann Bone Level Tapered Implants. Abutments are oval-shaped for narrow interdental spaces. Workflow involves CAD design of the restoration, followed by manufacturing at a validated Straumann milling center. Final components are cemented or screw-retained to the implant. Provides structural support for prosthetic teeth; aids in soft tissue healing via temporary restoration phase. Benefits include customized prosthetic fit and restoration of dental function.

Clinical Evidence

Bench testing only. Dynamic fatigue and static strength testing performed per FDA guidance for Class II Special Controls for Root-form Endosseous Dental Implants and Endosseous Dental Abutments. No clinical data provided.

Technological Characteristics

Material: Ti-6Al-7Nb (TAN). Form factor: Oval, 1.0-3.0 mm gingival heights. Connection: Small CrossFit® (SC). Workflow: CAD-designed prosthetic restoration (zerion ML/UTML) manufactured via milling. Design parameters: 0.4-0.8 mm wall thickness, 0-30° angulation. Sterilization: Validated per FDA guidance.

Indications for Use

Indicated for use as an aid in prosthetic rehabilitations. Supports individual crowns or bridges. Temporary restorations may be used during healing phase. Final restorations placed upon osseointegration. Digitally designed copings/crowns must be manufactured at a validated Straumann milling center.

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® Ø2.9 mm Bone Level Tapered Implant (K162890)

Reference Devices

• Straumann® Variobase® Abutments (K170356)

Submission Summary (Full Text)

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October 5, 2018

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

Re: K173945

Trade/Device Name: Straumann® SC Variobase® Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implant abutment Regulatory Class: Class II Product Code: NHA Dated: August 17, 2018 Received: September 5, 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 (QS) 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 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) K173945

Device Name Straumann® SC Variobase® Abutments

#### Indications for Use (Describe)

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC Variobase® prosthetic components. A temporary restoration can be used prior to the insertion of the final components to maintain, stabilize and form the healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated. All digitally designed copings and/or crowns for use with the Strauman® 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) | X |
|----------------------------------------------|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | |

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Straumann® SC Variobase® Abutments

510(k) Summary

### K173945 510(k) Summary

### Submitter's Contact Information

Straumann USA, LLC (on behalf of Institut Straumann AG)

60 Minuteman Road

Andover, MA 01810

Phone Number: 1-978-747-2509

Fax Number: 1-978-747-0023

Contact Person: Jennifer M. Jackson, MS

Date Prepare: October 4, 2018

### Name of the Device

| Trade Names: | Straumann® SC Variobase® Abutments |
|----------------------|------------------------------------|
| Common Name: | Endosseous Dental Implant Abutment |
| Classification Name: | Endosseous Dental Implant Abutment |
| Regulation Number: | §872.3630 |
| Classification: | Class II |
| Product Codes: | NHA |

### Predicate Device(s)

Primary Predicate:

K162890 – Straumann® Ø2.9 mm Bone Level Tapered Implant

Reference Devices:

K170356 – Straumann® Variobase® Abutments

### Device Description

There are three components to the Straumann® SC Variobase® Abutments:

- Straumann® SC Variobase® Abutments (Ti-base) .
- . Prosthetic restoration (coping and/or crown)

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### Straumann® SC Variobase® Abutments

510(k) Summary

- . Basal Screw
The Straumann® SC Variobase® Abutments are manufactured from TAN. The abutments are oval in shape to accommodate narrow interdental spaces and are available with three different gingival heights ranging between 1.0 mm and 3.0 mm. The abutments will be delivered with the corresponding basal screw.

The prosthetic restoration (the second component of the two-piece abutment) is digitally designed using CAD software and sent to Straumann for manufacture at a validated milling center.

The purpose of this submission is to add the following materials to the previously cleared list of top-half materials for use on the previously cleared Straumann® SC Variobase® Abutments:

- Digital materials: .
- o zerion ML
- o zerion UTML

The following design parameters must be followed when designing the prosthetic restoration in CAD Software:

| | zerion ML | zerion UTML |
|------------------------|-----------|-------------|
| Minimum Wall Thickness | 0.4 mm | 0.8 mm |
| Minimum Angulation | 0° | 0° |
| Maximum Angulation | 30° | 30° |

### Intended Use

Straumann® SC Variobase® Abutments are intended to be placed into Straumann® Bone Level Tapered Implants Ø2.9 mm to provide support for individual crowns or bridges.

### Indications for Use

Straumann® SC Variobase® abutments are indicated for use as an aid in prosthetic rehabilitations. The prosthetic restoration can be cemented on the Straumann® SC 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

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### Straumann® SC Variobase® Abutments

510(k) Summary

healing phase. Final abutments and restorations may be placed into occlusion when the implant is fully osseointegrated.

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.

### Technological Characteristics

The technological principles and intended use are identical for the subject and reference predicate devices. The devices are intended to be placed into dental implants to provide support for individual crowns or bridges. The main difference in the technological characteristics between the subject and primary predicate devices is the coping/crown materials. The coping/crown material is identical to the reference predicate device. The technological characteristics of the subject devices are compared to the primary and reference predicates in Table 1.

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# Straumann® SC Variobase® Abutments

510(k) Summary

| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE<br>PREDICATE DEVICE |
|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| K Number | Subject Device | K162890 | K170356 |
| Material | Ti-6Al-7Nb | Ti-6Al-7Nb | Ti-6Al-7Nb |
| Indications for<br>Use Statement | Straumann® SC Variobase®<br>abutments are indicated for<br>use as an aid in prosthetic<br>rehabilitations. The<br>prosthetic restoration can<br>be cemented on the<br>Straumann® SC Variobase®<br>prosthetic components. A<br>temporary restoration can<br>be used prior to the<br>insertion of the final<br>components to maintain,<br>stabilize and form the soft<br>tissue during the healing<br>phase. Final abutments and<br>restorations may be placed<br>into occlusion when the<br>implant is fully<br>osseointegrated.<br>All digitally designed<br>copings and/or crowns for<br>use with the Straumann®<br>Variobase® Abutment<br>system are intended to be<br>sent to Straumann for<br>manufacture at a<br>validated milling center. | Straumann® SC Variobase®<br>abutments are indicated for<br>use as an aid in prosthetic<br>rehabilitations. The<br>prosthetic restoration can<br>be cemented on the<br>Straumann® SC Variobase®<br>prosthetic components. A<br>temporary restoration can<br>be used prior to the<br>insertion of the final<br>components to maintain,<br>stabilize and form the soft<br>tissue during the healing<br>phase. Final abutments and<br>restorations may be placed<br>into occlusion when the<br>implant is fully<br>osseointegrated.<br>All digitally designed<br>copings and/or crowns for<br>use with the Straumann®<br>Variobase® Abutment<br>system are intended to be<br>sent to Straumann for<br>manufacture at a<br>validated milling center. | The Straumann®<br>Variobase® Abutment is a<br>titanium base placed onto<br>Straumann dental implants<br>to provide support for<br>customized prosthetic<br>restorations. Straumann®<br>Variobase® Abutments are<br>indicated for screw-<br>retained single tooth or<br>cement-retained single<br>tooth and bridge<br>restorations. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann® Variobase®<br>Abutment system are<br>intended to be sent to<br>Straumann for<br>manufacture at a validated<br>milling center. |
| Implant to<br>Abutment<br>Connection | Small CrossFit® (SC) | Small CrossFit® (SC) | Narrow CrossFit® (NC)<br>Regular CrossFit® (RC)<br>Narrow Neck CrossFit®<br>(NNC)<br>Regular Neck (RN)<br>Wide Neck (WN) |
| Diameter or<br>Minor Oval<br>Dimension/<br>Major Oval<br>Dimension | 3.3/4.3 mm | 3.3/4.3 mm | Ø3.8 - 7.0 mm |
| Overall<br>Abutment<br>Height | 6.7 – 8.7 mm | 6.7 – 8.7 mm | 5.9 - 8.9 mm |
| Coping/ Crown<br>Material | Digital Workflow:<br>zerion ML (permanent)<br>zerion UTML (permanent) | Traditional Workflow:<br>Type 4 metals (ISO<br>22674)<br>IPS e.max® Press<br>Ceramic<br>Digital Workflow:<br>coron® (permanent)<br>zerion® LT (permanent)<br>polycon® ae (temporary) | Digital Workflow:<br>zerion ML (permanent)<br>zerion UTML (permanent) |
| FEATURE | PROPOSED DEVICE | PRIMARY PREDICATE<br>DEVICE | REFERENCE<br>PREDICATE DEVICE |
| K Number | Subject Device | K162890 | K170356 |
| Design<br>Workflow | Wax-up or Open CAD | Wax-up or Open CAD | Wax-up or Open CAD<br>CARES® Visual |
| Design<br>Parameters -<br>Minimum Wall<br>Thickness | zerion ML - 0.4 mm<br>zerion UTML – 0.8 mm | zerion® LT – 0.4 mm<br>coron® - 0.3 mm<br>polycon® ae - 0.5 mm | zerion ML - 0.4 mm<br>zerion UTML - 0.8 mm |
| Design<br>parameters -<br>Minimum<br>Angulation | 0° | 0° | 0° |
| Design<br>Parameters -<br>Maximum<br>Angulation | 30° | 30° | 30° |
| Manufacturing<br>Workflow | Straumann Milling | Traditional casting or<br>pressing<br>or<br>Straumann Milling | Straumann Milling |
| Mode of Action | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained |

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# Straumann® SC Variobase® Abutments

#### 510(k) Summary

Table 1 – Comparison of subject device versus reference device (Straumann® SC

Variobase® Abutments)

### Performance Testing

The following performance data were provided in support of the substantial equivalence determination.

### Sterilization Validation

The sterilization process for the Straumann® SC Variobase® Abutments as recommended in the labeling was validated according to applicable recommendations in the FDA guidance document "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling, issued on March 17, 2015".

The subject devices have the identical sterilization methods compared to the primary and reference predicate devices. No new issues regarding sterilization were raised for the subject devices. Therefore, no additional sterilization validations were required.

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Straumann® SC Variobase® Abutments

510(k) Summary

#### Biocompatibility Testing

The subject devices were evaluated according to ISO 10993-1:2009 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" and the biocompatibility evaluation flow chart according to the FDA Guidance document "Use of International Standard ISO 10993-1, 'Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process', Guidance for Industry and Food and Drug Administration Staff, Document issued on: June 16, 2016" for the subject devices.

The subject devices have the identical nature of body contact, contact duration, material formulation, manufacturing processes, and sterilization methods compared to the primary and reference predicate devices. No new issues of biocompatibility are raised for the subject devices. Therefore, no additional biocompatibility testing was required.

#### Bench Testing

Dynamic fatigue and static strength tests were conducted according to the FDA guidance document "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" and demonstrated the Straumann® SC Variobase® Abutments are equivalent to the primary predicate devices.

#### Conclusion

The documentation submitted in this premarket notification demonstrates the Straumann® SC Variobase® Abutments are substantially equivalent to the primary predicate and reference devices.