STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,

K132219 · Straumann USA, LLC · NHA · Feb 21, 2014 · Dental

Device Facts

• Record ID: K132219
• Device Name: STRAUMANN(R) VARIOBASE(TM) ABUTMENT NNC, STRAUMANN(R) VARIOBASE(TM) ABUTMENT RN, STRAUMANN(R) VARIOBASE(TM) ABUTMENT WN,
• Applicant: Straumann USA, LLC
• Product Code: NHA · Dental
• Decision Date: Feb 21, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Straumann® Variobase " Abutments are pre-manufactured (stock) abutments intended to be placed onto Straumann dental implants to provide support for customized prosthetic restorations such as crowns and bridges. Straumann® Variobase " Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

Device Story

Straumann® Variobase™ Abutments are two-piece, pre-manufactured titanium-alloy abutments (Ti-bases) for Straumann dental implants. Dental laboratory technicians design the secondary component (coping/crown) using open CAD software via burnout coping or STL model. The coping/crown is manufactured using validated Straumann milling. The device provides support for customized prosthetic restorations (crowns/bridges). Used in dental laboratories and clinical settings; operated by dental technicians and clinicians. Output is a customized prosthetic restoration; aids in tooth replacement and restoration of dental function.

Clinical Evidence

Bench testing only. Dynamic fatigue testing conducted per FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments' to evaluate fatigue load limits using Polycon® ae and Zerion® materials.

Technological Characteristics

Two-piece abutment system. Ti-base material: titanium-aluminum-niobium alloy (ISO 5832-11). Coping/crown materials: Polycon® ae, Zerion®. Design: CAD-based custom coping/crown manufactured via validated milling. Connectivity: Compatible with Straumann NNC, RN, WN, NC, and RC implant platforms.

Indications for Use

Indicated for patients requiring screw-retained single tooth or cement-retained single tooth and bridge 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 CARES Variobase Abutment NNC, RN, WN, NC, RC (K120822)
• Ti-Base Abutment (K111935)

Submission Summary (Full Text)

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## Traditional 510(k) Submission

Straumann® Variobase™ Abutments

FEB 21 2014

510(k) Summary

### 510(k) Summary 5

#### Submitter's Contact Information 5.1

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

60 Minuteman Road

Andover, MA 01810

Phone Number: 1-978-747-2509

1-978-747-0023 Fax Number:

Contact Person: Jennifer M. Jackson, MS

Date of Submission: 20-Feb-2014

#### 5.2 Name of the Device

| Trade Name: | Straumann® Variobase™ Abutments |
|----------------------|---------------------------------------|
| Common Name: | Dental Implant Abutment |
| Classification Name: | Abutment, Implant, Dental, Endosseous |
| Regulation Number: | §872.3630 |

### 5.3 Predicate Device(s)

- K120822, Straumann CARES Variobase Abutment NNC, RN, WN, NC, RC . (Institut Straumann AG)
- K111935. Ti-Base Abutment (NT-Trading GmbH & Co. KG) 0

#### Device Description 5.4

The Straumann® Variobase " Abutments are pre-manufactured (stock) abutments, sometimes referred to as "Ti-bases". Straumann® Variobase" Abutments are available to fit Straumann® dental implant platforms NNC (Narrow Neck CrossFit®), RN (Regular Neck), WN (Wide Neck), NC (Narrow CrossFit®), and 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

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

# Traditional 510(k) Submission

# Straumann® Variobase™ Abutments

### 510(k) Summary

dental laboratory using either a burnout coping or STL model for open CAD software. The coping and/or crown would be manufactured via validated Straumann milling.

### 5.5 Intended Use

Straumann® Variobase " Abutments are pre-manufactured (stock) abutments intended to be placed onto Straumann dental implants to provide support for customized prosthetic restorations such as crowns and bridges. Straumann® Variobase " Abutments are indicated for screw-retained single tooth or cement-retained single tooth and bridge restorations.

### Technological Characteristics 5.6

Straumann® Variobase™ Abutments are two-piece abutments consisting of a premanufactured (stock) abutment made from a titanium-aluminum-niobium alloy and a coping and/or crown which is designed in the dental laboratory by a dental technician using open CAD software and manufactured via validated Straumann milling.

The Ti-base components of the Straumann® Variobase™ Abutments are identical to the Ti-base components of the Straumann predicate (K120822). The Ti-base components are also equivalent to the Ti-base components identified in K111935.

The materials which may be used to manufacture the coping/crown component of the Straumann® Variobase " Abutments are identical to the identified predicate devices and include:

Polycon® ae (temporary restorations - K120822) Milling: Zerion® (K120822)

### 5.7 Performance Testing

The material used in the manufacture of Straumann® Variobase™ Abutments is a titanium-aluminum-niobium alloy which meets the requirements of ISO 5832-11. Bench testing was performed with Polycon® ae and Zerion® to evaluate the fatigue load limits of the proposed Straumann® Variobase™ Abutments. Dynamic fatigue tests were conducted in according to the FDA guidance document "Guidance for Industry and FDA

5-2

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## Traditional 510(k) Submission

# Straumann® Variobase™ Abutments

510(k) Summary

Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".

### 5.8 Conclusion

The documentation submitted in this premarket notification demonstrates that the Straumann® Variobase" Abutments are substantially equivalent to the predicate devices and do not pose new issues of safety and effectiveness when used as labeled.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Public Health Service

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

February 21, 2014

Straumann USA. Limited Liability Company Jennifer M. Jackson, MS 60 Minuteman Road Andover, MA 01810

Re: K132219

Trade/Device Name: Straumann® Variobase ™Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Abutment, Implant, Dental, Endosseous Regulatory Class: II Product Code: NHA Dated: January 23, 2014 Received: January 24, 2014

Dear Ms. 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.

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Page 2 - Ms. Jackson

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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address

Sincerely yours.

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

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for

Erin I. Keith, M.S. 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): K 13 2219

Device Name: Straumann® Variobase™ Abutments

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.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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