(52 days)
Not Found
Not Found
No
The summary describes a physical dental abutment made of gold alloy and focuses on mechanical performance testing. There is no mention of software, algorithms, image processing, AI, or ML.
No.
The device acts as a support for prosthetic reconstructions, which is a structural role, not a therapeutic one that treats or prevents a disease.
No
Explanation: The device is a dental abutment intended for prosthetic restorations, not for diagnosing medical conditions. Its purpose is to provide support for crowns, bridges, and overdentures.
No
The device description explicitly states the abutment is made of a non-oxidizing gold alloy, indicating it is a physical hardware component. The performance studies also focus on physical properties like fatigue testing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the abutments are used in connection with the prosthetic restoration of dental implants, providing support for crowns, bridges, and overdentures. This is a surgical/implantable device used directly on a patient.
- Device Description: The description details a physical component made of a gold alloy intended for placement on a dental implant.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze biological samples. This device is implanted within the body to support dental prosthetics.
N/A
Intended Use / 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.
Product codes
NHA
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Bench testing was performed, including fatigue testing in accordance with FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results demonstrated that the device functions as intended and met pre-determined acceptance criteria.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 872.3630 Endosseous dental implant abutment.
(a)
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.(b)
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.)
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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
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:
-
- 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.
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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
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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
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