NNC GOLD ABUTMENT FOR BRIDGES

K113606 · Straumann USA · NHA · Jan 27, 2012 · Dental

Device Facts

Record IDK113606
Device NameNNC GOLD ABUTMENT FOR BRIDGES
ApplicantStraumann USA
Product CodeNHA · Dental
Decision DateJan 27, 2012
DecisionSESE
Submission TypeSpecial
Regulation21 CFR 872.3630
Device ClassClass 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, bridges and overdentures.

Device Story

Permanent dental abutment; designed for placement on Straumann Narrow Neck CrossFit (NNC) tissue level implants (3.3mm diameter). Provides structural support for prosthetic reconstructions including crowns, bridges, and overdentures. Used in clinical dental settings by dental professionals. Device functions as mechanical interface between endosseous implant and prosthetic restoration.

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 safety.

Technological Characteristics

Non-oxidizing gold alloy abutment; designed for 3.3mm diameter NNC tissue level implants. Mechanical connection interface. Fatigue tested per FDA guidance.

Indications for Use

Indicated for patients requiring prosthetic restoration of Straumann dental implants, specifically for support of crowns, bridges, and overdentures.

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ K113606 ## 510(k) Summary Narrow Neck CrossFit (NNC) Gold Abutment for Bridges #### 1. Applicant's Name and Address JAN 2 7 2012 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: December 5, 2011 ### Name of the Device 3. | Trade Name: | Straumann Narrow Neck CrossFit (NNC) Gold<br>Abutment for Bridge Restorations | |----------------------|-------------------------------------------------------------------------------| | Common Name: | NNC Gold Abutment for Bridge Restorations | | Classification Name: | Endosseous Dental Implant Abutments | | Regulation Number: | §872.3630 | ## Legally Marketed Device to which Equivalence is Claimed (Predicate 4. Device) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ ### 5. Description of the Device Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge Restoration is a permanent abutment intended for placement on the - Straumann Narrow Neck CrossFit (NNC) tissue level Implant with a diameter : of 3,3mm. The abutment is made of a non-oxiding gold alloy. ## Intended Use of the Device 6. 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, bridges and overdentures. {1}------------------------------------------------ ## 7. Technological Characteristics The proposed device is substantially equivalent to the currently marketed device. They share the same indication for use, prosthetic platform, implant/abutment connection, and fundamental operating principles. ## 8. Performance Testing Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge restoration functions 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 guidance 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 Straumann Narrow Neck CrossFit (NNC) Gold Abutment for bridge restoration functions as intended and met the pre-determined acceptance criteria. The Straumann Narrow Neck CrossFit (NNC) Gold Abutment for bridge restoration is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridge is substantially equivalent to the Straumann Narrow Neck CrossFit (NNC) Gold Abutment for crown restoration. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {2}------------------------------------------------ ## DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/2/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services USA. The seal is circular and features the department's name around the perimeter. In the center of the seal is an abstract image of an eagle. ## Public Health Service 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 JAN 2 7 2012 Re: KI13606. Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges Regulation Number: 21 CFR 872.3630 Regulation Name: . Endosseous Dental Implant Abutments Regulatory Class: NHA Product Code: II Dated: December 22, 2011 Received: December 28, 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 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. {3}------------------------------------------------ Page 2 - Ms. Desrochers 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 (rea neting of medical device-related adverse events) (21 CFR 803); good manufacturing (reporting of increats 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours, for Anthony Dubtson 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 {4}------------------------------------------------ # Indications for Use Statement KI136606 510(k) Number (if known): Device Name: Straumann Narrow Neck CrossFit (NNC) Gold Abutment for Bridges 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, bridges and overdentures. X Prescription Use (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) Susan Ruaser (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K113606 Special 510(k) Submission: NNC Gold Abutment, Bridges December 5, 2011 Page 14 of 86 Straumann USA Page 1 of 1
Innolitics
510(k) Summary
Decision Summary
Classification Order
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