NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS

K110580 · Straumann USA · NHA · Aug 12, 2011 · Dental

Device Facts

• Record ID: K110580
• Device Name: NARROW CONNECTION STRAUMANN ANATOMIC IPS E.MAX ABUTMENTS
• Applicant: Straumann USA
• Product Code: NHA · Dental
• Decision Date: Aug 12, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges. Anatomic IPS e.max Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations.

Device Story

Permanent dental abutments for Straumann 3.3mm Narrow Connection (NC) Bone Level Implants; fabricated from Zirconium Dioxide with Titanium Alloy basal screw; available in straight/15° angled configurations and 2.0mm/3.5mm gingival heights; white or shaded. Used by dental professionals to support prosthetic reconstructions (crowns/bridges). Device provides structural interface between implant and prosthesis. Benefits include restoration of dental function and aesthetics.

Clinical Evidence

Bench testing only. Fatigue testing conducted in accordance with FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments' to verify performance and structural integrity.

Technological Characteristics

Materials: Zirconium Dioxide abutment, Titanium Alloy basal screw. Configuration: Straight and 15° angled. Gingival heights: 2.0mm and 3.5mm. Interface: Straumann Narrow Connection (NC) for 3.3mm diameter implants. Mechanical fixation via screw-retained or cement-retained methods.

Indications for Use

Indicated for patients requiring prosthetic restoration of Straumann dental implants, specifically for screw-retained single-tooth restorations and cement-retained single-tooth and bridge restorations.

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 Modified Dental Abutments (K091701)

Submission Summary (Full Text)

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# AUG 1 2 2011 510(K) Summary

#### 1. Applicant's Name and Address

. "

Straumann US (on behalf of Institut Straumann AG) 60 Minuteman Rd. Andover, MA 01810 Telephone Number: 800-448-8168, ext 2513 978-747-0023 Fax Number: Contact Person: Elaine Alan Senior Regulatory Affairs Specialist

#### 2. Date of Submission: February 28, 2011

#### 3. Name of the Device

| Trade Name: | Narrow Connection (NC) Straumann Anatomic<br>IPS e.max Abutments |
|----------------------|------------------------------------------------------------------|
| Common Name: | NC Anatomic IPS e.max Abutments |
| Classification Name: | Endosseous Dental Implant Abutments |
| Regulation Number: | §872.3630 |

### Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device)

Straumann Modified Dental Abutments, K091701

#### ર. Description of the Device

Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments are permanent abutments intended for placement onto the Straumann Narrow Connection Bone Level Implants with the diameter of 3.3mm. The abutments are made of Zirconium Dioxide with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations with gingival heights of 2.0mm and 3.5mm, and are available in two colors of white and shaded.

#### 6. Intended Use of the Device

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

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Anatomic IPS e.max Abutments are indicated for screw-retained singletooth restorations and cement-retained single tooth and bridge restorations.

#### 7. Technological Characteristics

The proposed device is substantially equivalent to the currently marketed device. They share the same indication for use, material and fundamental operating principles.

#### 8. Performance Testing

Verification and validation testing were performed to ensure that the Straumann Narrow Connection (NC) Anatomic IPS e.max Abutments function as intended and that the modifications do not impact the performance of the device. Testing included:

- 1. Performance Testing
- i. Fatigue Testing in accordance to FDA quidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

#### 9. Conclusion

The results from the testing conducted demonstrated that the Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments function as intended and met the pre-determined acceptance criteria.

The Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Connection (NC) Anatomic IPS e.max Abutments are substantially equivalent to the named predicate device and is safe and effective for its intended use.

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

Ms. Elaine Alan Senior Regulatory Affairs Specialist Straumann USA 60 Minuteman Road Andover. Massachusetts 01810

AUG 1 2 2011

Rc: K110580

Trade/Device Name: Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: June 22, 2011 Received: June 23, 2011

Dear Ms. Alan:

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 cither 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. Alan

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours.

A. 1
B. W
C. S

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devi Office of Device Evaluation Center of Devices and Radiological Health

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## Indications for Use

510(k) Number (if known): K110580

Device Name: Narrow Connection (NC) Straumann Anatomic IPS e.max Abutments

Indications for Use:

Abutments are used in connection with the prosthetic restoration of Straumann dental implants. Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.

Anatomic IPS e.max Abutments are indicated for screw-retained single-tooth restorations and cement-retained single tooth and bridge restorations.

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

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

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

Concurrence of DCRH, Office of Device Evaluation (ODE)

Swart Karr

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(Division Sign-Off) Division of Anesthesiology. General Hospital Infection Control. Dental Devic

510(k) Number: Filos

Straumann, USA Page 17 of 20