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. Straumann Narrow Neck CrossFit Cementable Abutments are indicated for cement-retained single tooth and bridge restorations.

Device Description

Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm. The abutments are made of Titanium Grade 4 with a corresponding basal screw made of Titanium Alloy. The abutments are available in straight and 15° angled configurations.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the NNC Cementable Abutments, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study that Proves Acceptance
Performance Testing	Fatigue Performance	"function as intended and met the pre-determined acceptance criteria."	Fatigue Testing in accordance to FDA guidance document "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."
Overall Equivalence	Substantial Equivalence to Predicate Device	"are substantially equivalent to the named predicate device and is safe and effective for its intended use."	Performance bench testing and risk analysis.
Intended Functionality	Function as Intended	"function as intended"	Performance bench testing and risk analysis, as well as the above fatigue testing.

Missing Information: It's important to note that the document states that the device met pre-determined acceptance criteria for fatigue testing and overall performance. However, it does not quantify these acceptance criteria (e.g., "must withstand X cycles at Y load" or "fracture strength must be Z MPa"). Similarly, it doesn't provide specific numerical results of the device performance against these criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: Not specified in the provided text. The document refers to "Performance Testing" which included fatigue testing, but the number of devices tested is not mentioned.
Data Provenance: Not specified. The company is Straumann USA, but the location where the testing was conducted is not stated. The study is prospective in the sense that newly manufactured abutments were tested.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not Applicable. This type of information (experts establishing ground truth for a test set) is typically relevant for studies involving diagnostic tools or image analysis where human interpretation is the "gold standard." For a mechanical device like a dental abutment, the "ground truth" is established through engineering and material science standards (e.g., ASTM, ISO, or FDA guidance documents for mechanical testing), not expert consensus in the diagnostic sense.

4. Adjudication Method for the Test Set

Not Applicable. See explanation above. Mechanical test results are objective measurements against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. An MRMC study is relevant for diagnostic imaging or interpretation tasks where human readers make assessments. This is a mechanical device performance study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

No. This question is typically asked for AI/ML-based diagnostic devices. This is a mechanical device, so there is no "algorithm only" performance in that context. The "standalone" performance here refers to the device itself (the abutment) without human interaction influencing its mechanical integrity during the test.

7. The type of ground truth used

The ground truth for the performance testing was based on "FDA guidance document 'Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments.'" This guidance document likely defines the mechanical testing protocols and performance thresholds (e.g., minimum fatigue life, maximum deformation) that dental abutments must meet to be considered safe and effective.

8. The sample size for the training set

Not Applicable. This question is relevant for AI/ML models that require a training set. This is a mechanical device, not an AI/ML system.

9. How the ground truth for the training set was established

Not Applicable. See explanation above.

Summary

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Narrow Neck CrossFit (NNC) Cementable Abutments Special 510(k) Section 5: 510(k) Summary

DEC 2 8 2011

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 Senior Regulatory Affairs Specialist

2. Date of Submission: November 4, 2011

3. Name of the Device

Trade Name:	Straumann Narrow Neck CrossFit (NNC)Cementable Abutments
Common Name:	NNC Cementable Abutments
Classification Name:	Endosseous Dental Implant Abutments
Regulation Number:	§872.3630

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

Straumann Narrow Neck Connection (NNC) Gold Abutment for crowns, K111357 Straumann Narrow Connection (NC) Cementable Abutments, K080286 Straumann Narrow Neck (NN) CARES Titanium Abutment, K082545

5. Description of the Device

6. Intended Use of the Device

Response Letter: K113283 December 9, 2011 Straumann NNC Cementable Abutments

Straumann, USA Page 7 of 14

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< 113283

Narrow Neck CrossFit (NNC) Cementable Abutments Special 510(k) Section 5: 510(k) Summary

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. Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are indicated for 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, prosthetic platform, implant/abutment connection, and fundamental operating principles.

Performance Testing 8.

Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Cementable Abutments function 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 Sraumann Narrow Neck CrossFit (NNC) Cementable Abutments function as intended and met the pre-determined acceptance criteria.

December 9, 2011

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K II 3283

Narrow Neck CrossFit (NNC) Cementable Abutments Special 510(k) Section 5: 510(k) Summary

The Straumann Narrow Neck CrossFit (NNC) Cementable Abutments is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Cementable Abutments are substantially equivalent to the named predicate device and is safe and effective for its intended use.

Response Letter: K113283 Straumann NNC Cementable Abutments December 9, 2011

Straumann, USA Page 9 of 14

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Image /page/3/Picture/1 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the edge. In the center of the seal is a stylized image of an eagle with its wings spread, facing to the right. The eagle is composed of thick, curved lines, giving it a modern and abstract appearance.

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

DEC 2 8 2011

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

Re: K113283

Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) Cementable Abutments Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment . Regulatory Class: II Product Code: NHA Dated: December 9, 2011 Received: December 12, 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 mendments, or to devices that have been reclassified in accordance with the provisions of Amendinens, or to av roometic Act (Act) that do not require approval of a premarket the rederal F 00d, Drag, and Coou may, therefore, market the device, subject to the general approvisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, legallents for annual vegainst 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 (1 will 1), it thay be basjon 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 (1 CFR Partice 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 Sempilation of fication" (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.goy/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Nh 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

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Cementable Abutments

Indications for Use:

Narrow Neck CrossFit Cementable Abutments are indicated for 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 DCRH, Office of Device Evaluation (ODE)

Michael
(Division Sign-Off)

Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Special 510(k) Submission: NNC Cementable Abutments November 4, 2011

113283

Page 1 of 1

Page 15 of 75 Straumann USA

Regulation Number and Section

§ 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.)