Straumann Variobase for Crown AS

K173379 · Institut Straumann AG · NHA · Mar 30, 2018 · Dental

Device Facts

• Record ID: K173379
• Device Name: Straumann Variobase for Crown AS
• Applicant: Institut Straumann AG
• Product Code: NHA · Dental
• Decision Date: Mar 30, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

Device Story

Titanium-alloy (Ti-6Al-7Nb) base (TiBase) connects to Straumann dental implants; supports customized prosthetic restorations (copings/crowns). Features angled screw channel allowing lateral displacement of screw-channel exit from occlusal/esthetic regions. Workflow: intra-oral/bench-top scanning; design via Straumann CARES Visual CAD software; manufacture at validated milling center. Components: TiBase, prosthetic restoration, basal screw. Used in dental clinics by clinicians; provides stable support for single/bridge restorations; benefits patient via improved esthetics and functional positioning of screw access.

Clinical Evidence

Bench testing only. Evidence includes dynamic fatigue testing per ISO 14801, software validation per IEC 62304, and sterilization validation per ISO 17665-1/2. Biocompatibility and fatigue performance supported by predicate data for specific restorative materials.

Technological Characteristics

Material: Ti-6Al-7Nb alloy. Dimensions: 3.8–7.0 mm diameter; 3.5–6.5 mm prosthetic height. Connectivity: CAD/CAM digital workflow (Straumann CARES Visual). Sterilization: Validated per ISO 17665. Software: Closed CAD system for prosthetic design.

Indications for Use

Indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations on Straumann dental implants. Includes use of temporary restorations to maintain/stabilize soft tissue during healing (placed out of occlusion).

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 CARES Variobase Abutments (K120822)
• Straumann Variobase Abutments (K170354)
• Straumann Variobase Abutments (K170356)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and the word "ADMINISTRATION" in a smaller font below.

March 30, 2018

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

Re: K173379

Trade/Device Name: Straumann® Variobase® for Crown AS Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: March 2, 2018 Received: March 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. 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.

{1}------------------------------------------------

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); good manufacturing practice requirements as set forth in 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.

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.

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

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K173379

Device Name

Straumann® Variobase® for Crown AS

Indications for Use (Describe)

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

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

図 Prescription Use (Part 21 CFR 801 Subpart D) 801 Subpart C)

□ Over-The-Counter Use (21 CFR

## 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 [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14) Equivalent

Page 1 of 1

{3}------------------------------------------------

# K173379 510(k) Summary

#### Submitter's Contact Information 1.1

| 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>Tel [phone]<br>Fax [phone] | | |
| Prepared By: | Dr. Gordon Dodds<br>Manager Design Control QM<br>Etkon GmbH | | |
| Date Prepared: | March 26, 2018 | | |
| Product Code(s): | NHA (§872.3630) | | |
| Device Class: | II (§872.3630) | | |
| Classification Panel: | Dental | | |
| 1.2 Name of the Device | | | |
| Classification Name: | Endosseous dental implant abutment (§872.3630) | | |
| Proprietary Name: | Straumann® Variobase® for Crown AS | | |
| 1.3 Predicate Device(s) | | | |
| Predicate Device(s): | • K142890 – Straumann Variobase Abutments | | |
| Reference Device(s): | • K120822 – Straumann CARES Variobase Abutments<br>• K170354 – Straumann Variobase Abutments<br>• K170356 - Straumann Variobase Abutments | | |

{4}------------------------------------------------

#### 1.4 Device Description

The Straumann® Variobase® for Crown AS are pre-manufactured (stock) lower parts of two-piece abutments, sometimes referred to as "bonding bases" or "TiBases". The Straumann® Variobase® for Crown AS are available to fit to Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and RC (Regular CrossFit®).

There are two prosthetic heights to allow for treatment flexibility and for each of the bone level connections (NC, RC), there are gingiva heights of 1.00 mm, 2.00 mm and 3.00 mm. The Straumann® Variobase® for Crown AS provides the dental technician and patient with the possibility to have an "Angled Screw channel" in the crown.

The lower side of the Straumann® Variobase® for Crown AS and a small angulation of the innerwall allows the screw-channel exit to move from a position directly above the implant screw channel to a laterally displaced position. Thus the screw-channel exit can be moved a small distance from occlusal contact or esthetic regions where its potential impact to esthetics is smaller, in Figure 1 the screw-channel exit has been moved from the occlusal contact point of an incisor to behind the incisal edge. The patient-specific upper part of the two-piece abutment (referred to as coping or crown) is to be designed via a traditional workflow of casting/pressing or a digital workflow using the dental CAD software Straumann CARES Visual.

There are three components to the Straumann® Variobase® for Crown AS:

- . Straumann® Variobase® for Crown AS (Ti-base)
- o Prosthetic restoration (coping and/or crown)
- o Basal Screw

Image /page/4/Picture/9 description: The image shows a dental implant with several labeled components. The "Basal screw" is at the top, followed by the "Prosthetic restoration (full contour crown)". Below that is the "Straumann® Variobase AS Ti-base", which connects to the implant itself. The implant is a cylindrical, screw-like structure designed to be embedded in the jawbone.

Figure 1 – Two-piece abutment consisting of a Straumann® Variobase® for Crown AS and a milled coping

{5}------------------------------------------------

The following is an overview of the possible prosthetic restoration (coping and/or crown) materials:

- Cast materials: ●
- Type 4 metals (ISO 22674) O
- o Base metal alloys (e.g., cobalt-chromium (CoCr))
- o Noble metal alloys (e.g., gold alloy)
- Press materials:
- o IPS e.max® Press Ceramic
- Digital materials: ●
- coron® O
- zerion® LT O
- polycon® ae O
- zerion ML O
- zerion UTML O
- IPS e.max® CAD Ceramic O
- O n!ce

#### 1.5 Intended Use

Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations.

#### 1.6 Indications for Use

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

{6}------------------------------------------------

#### 1.7 Technological Characteristics

The technological characteristics of the subject devices are compared to the primary predicate and reference devices in the following table.

| Feature | SUBJECT<br>Straumann® Variobase® for<br>Crown AS | PREDICATE<br>K142890, Straumann<br>Variobase Abutments | REFERENCE<br>K120822 Straumann CARES<br>Variobase Abutment | Equivalence<br>Discussion |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Straumann® Variobase® for<br>Crown AS is a titanium base<br>placed onto Straumann dental<br>implants to provide support for<br>customized prosthetic<br>restorations. Straumann®<br>Variobase® for Crown AS are<br>indicated for screw retained<br>single tooth or cement-retained<br>single tooth and bridge<br>restorations. A temporary<br>restoration can be used prior to<br>the insertion of the final<br>components to maintain,<br>stabilize and form the soft tissue<br>during the healing phase.<br>Temporary restorations are<br>indicated to be placed out of<br>occlusion. All digitally designed<br>copings and/or crowns for use<br>with the Straumann® Variobase®<br>for Crown AS are intended to be<br>sent to Straumann for<br>manufacture at a validated<br>milling center. | 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. All digitally<br>designed copings and/or<br>crowns for use with the<br>Straumann Variobase<br>Abutment system are intended<br>to be sent to Straumann for<br>manufacture at a validated<br>milling center. | 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. | Identical<br>Temporary materials<br>crowns (Polycon AE) are<br>used with the subject<br>and predicate devices.<br>The subject devices<br>include advice to ensure<br>that temporary<br>restorations are placed<br>out of occlusion in order<br>to assist with implant<br>stabilization.<br>Updates to the predicate<br>device IFUs, made since<br>510(k) clearance, give<br>identical advice as the<br>subject device. |
| TiBase<br>Material | Titanium-Aluminum-Niobium<br>alloy<br>(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium<br>alloy<br>(Ti-6Al-7Nb) | Titanium-Aluminum-Niobium<br>alloy<br>(Ti-6Al-7Nb) | Identical |

| Table 1 - Device Substantial Equivalence Comparison - Straumann® Variobase® for Crown AS |
|------------------------------------------------------------------------------------------|
|------------------------------------------------------------------------------------------|

{7}------------------------------------------------

| Feature | SUBJECT<br>Straumann® Variobase® for<br>Crown AS | PREDICATE<br>K142890, Straumann<br>Variobase Abutments | REFERENCE<br>K120822 Straumann CARES<br>Variobase Abutment | Equivalence<br>Discussion |
|------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Abutment<br>Diameter | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | 3.8 mm – 7.0 mm | Identical |
| Prosthetic Height<br>(Abutment Post<br>Height) | 3.5 mm – 6.5 mm | 3.5 mm - 4.5 mm | 3.5 mm – 4.5 mm | Equivalent<br>The option for additional<br>height of the apical part<br>of the TiBase in<br>Straumann® Variobase®<br>for Crown AS provides<br>for a larger area of<br>retentive cement and<br>material for resisting<br>force. |
| Mode of<br>Attachment | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Screw-retained or cement<br>retained | Identical |
| Basal Screws | TAN Basal screws for NC/RC,<br>NNC. RN/WN interfaces with a<br>wider screwhead (~10% wider) ,<br>to allow for up to 25° of<br>angulation with respect to the<br>Variobase AS axis with an<br>angled screwdriver. Screws are<br>marked with a green ring so they<br>can be identified. | TAN Basal screws for NC/RC,<br>NNC, RN/WN interfaces, with<br>limited angled entry of<br>screwdriver. | TAN Basal screws for NC/RC,<br>NNC, RN/WN interfaces, with<br>limited angled entry of<br>screwdriver. | Equivalent<br>A wider screw head<br>permits the angulation.<br>The cone below the<br>screwhead is slightly<br>longer to make the<br>screw head wider. The<br>screws have the same<br>overall length, |
| Reusable | No | No | No | Identical |
| Source of Input<br>Files for Crown<br>Design | Intra-Oral Scanners<br>Bench-top Scanners | Intra-Oral Scanners<br>Bench-top scanners | Intra-Oral Scanners<br>Bench-top scanners | Identical |
| Design<br>Environment | Straumann CARES Visual:<br>Closed CAD System facilitating<br>the design of tooth-borne<br>restorations and restorations<br>used in conjunction with the<br>devices of the Straumann Dental<br>Implant System (SDIS). | Straumann CARES Visual:<br>Closed CAD System facilitating<br>the design of tooth-borne<br>restorations and restorations<br>used in conjunction with the<br>devices of the Straumann Dental<br>Implant System (SDIS). | Straumann CARES Visual:<br>Closed CAD System facilitating<br>the design of tooth-borne<br>restorations and restorations<br>used in conjunction with the<br>devices of the Straumann Dental<br>Implant System (SDIS). | Identical |
| Feature | SUBJECT<br>Straumann® Variobase® for<br>Crown AS | PREDICATE<br>K142890, Straumann<br>Variobase Abutments | REFERENCE<br>K120822 Straumann CARES<br>Variobase Abutment | Equivalence<br>Discussion |
| Restoration<br>Types Supported | Patient-specific copings and<br>crowns for Variobase for Crown<br>AS | Patient-specific copings and<br>crowns for Variobase for Crown | Patient-specific copings and<br>crowns for Variobase for Crown | Equivalent |
| Supported<br>Restorative<br>Materials | Traditional Workflow:<br>Type 4 Metals (ISO 22674)<br>IPS e.max® Press Ceramic<br>Digital Workflow:<br>IPS e.max® CAD Ceramic<br>(permanent)<br>coron® (permanent)<br>zerion® (permanent)<br>polycon® ae (temporary)<br>zerion ML<br>zerion UTML<br>n!ce | Traditional Workflow:<br>Type 4 Metals (ISO 22674)<br>IPS e.max® Press Ceramic<br>Digital Workflow:<br>IPS e.max® CAD Ceramic<br>(permanent)<br>coron® (permanent) | Digital Workflow:<br>polycon® ae (temporary)<br>zerion® (permanent) | Identical |
| Fabrication<br>Workflow | Traditional casting or pressing<br>or<br>Straumann Milling | Traditional casting or pressing<br>or<br>Straumann Milling | Straumann Milling | Identical |
| Reusable | No | No | No | Identical |

{8}------------------------------------------------

{9}------------------------------------------------

#### 1.8 Performance Testing

Per Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments dated May 12, 2004, the substantial equivalence of the subject device(s) are satisfactorily addressed via bench studies.

The following testing has been conducted:

- Dynamic fatigue testing conforming to FDA guidance and ISO 14801. ●
- Software validation conforming to the requirements of IEC 62304. ●
- o Sterilization validation conforming to ISO 17665-1 and ISO/TS 17665-2.

| Variobase<br>materials | Fatigue tests -<br>predicates | Sterilization<br>validation<br>predicates | Biocompatibility<br>testing -<br>predicates |
|---------------------------|-------------------------------|-------------------------------------------|---------------------------------------------|
| coron® | K142890 | K142890 | K142890 |
| zerion® LT | Subject device | Subject device | K120822 |
| polycon® ae | K142890 | K120822 | K142890 |
| zerion ML/ zerion<br>UTML | K170356 | K170356 | K170356 |
| n!ce | K170354 | K170354 | K170354 |
| IPS e.max CAD | K142890 | K142890 | K142890 |

●

#### 1.9 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 devices.