STRAUMANN DENTAL ABUTMENTS

K092814 · Straumann Manufacturing, Inc. · NHA · Dec 15, 2009 · Dental

Device Facts

• Record ID: K092814
• Device Name: STRAUMANN DENTAL ABUTMENTS
• Applicant: Straumann Manufacturing, Inc.
• Product Code: NHA · Dental
• Decision Date: Dec 15, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.3630
• Device Class: Class 2

Intended Use

The NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.

Device Story

Straumann NC Temporary Abutments are dental components used in conjunction with Straumann NC Bone Level Implants. These abutments serve as a foundation for the fabrication of temporary single crowns and bridges. They are intended for short-term use, specifically up to six months. The device is utilized in a clinical setting by dental professionals to support prosthetic restorations for patients who are partially or fully edentulous. The abutment is placed onto the dental implant, allowing the clinician to construct a temporary restoration, which aids in the patient's transition to a permanent prosthetic solution.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design and material similarity to the predicate device.

Technological Characteristics

Endosseous dental implant abutment; design and material composition identical to predicate device; intended for temporary use (up to 6 months).

Indications for Use

Indicated for use in Straumann NC Bone Level Implants for temporary restoration of single crowns and bridges for up to six months in patients requiring dental implant support.

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

• NC Temporary Abutments (K072679)

Submission Summary (Full Text)

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14092814

Section I 510(k) Summary DEC 1 5 2009

## 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 Fax Number: 978-747-0023 Contact Person: Elaine Alan Regulatory Affairs Specialist Date of Submission: September 11, 2009

#### 2. Name of the Device

Trade Name: Common Name: Classification Name: Regulation Number:

Straumann NC Temporary Abutments Abutment, Dental, Endosseous implants Abutment, Dental, Endosseous implants 8872.3630

- 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device)
NC Temporary Abutments, K072679

#### 4. Description of the Device

The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, permanent and temporary abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are temporary abutments.

Abutments are placed on dental implants to provide support for dental restorations. Temporary abutments act as a basis for the fabrication of individual temporary restorations and temporary bridges on Straumann Dental Implants.

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### 5. Intended Use of the Device

The NC Temporary Abutments are intended for use with the Straumann Dental Implant for temporary restoration of single crowns and bridges.

## 6. Technological Characteristics

The proposed temporary abutments are substantially equivalent to the currently marketed devices. The intended use is identical to the predicate devices. The proposed abutment has the same material composition, basic design and fundamental operating principles to the currently marketed devices.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

Ms. Elaine Alan Regulatory Affairs Specialist Straumann Manufacturing, Incorporated 60 Minuteman Road Andover, Massachusetts 01810

DEC 1 5 2009

Re: K092814

Trade/Device Name: Straumann NC Temporary Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 3, 2009 Received: December 4, 2009

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.

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. 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 (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.

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely yours.

for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Indications for Use Statement

K092814

Device Name: Straumann NC Temporary Abutments

Indications for Use:

The Straumann NC Temporary Abutments are indicated for use in Straumann NC Bone Level Implants for temporary restorations of single crowns and bridges for up to six months.

X Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

# Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

TSBetz DDS for Dr. K.P. Mulvey (Acting)
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Number: K092814

510(k) Submission: NC Temporary Abutments Proprietary and Confidential September 11, 2009

Straumann US -Page-5