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.

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

Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days.

Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days.

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

Device Description

Straumann Narrow Neck CrossFit (NNC) Solid Abutments are permanent abutments intended for placement onto the Straumann Narrow Neck CrossFit (NNC) tissue level Implants with the diameter of 3.3mm, K111357. The abutments are made of Titanium Grade 4. The abutments are available in straight configurations only. Temporary abutments, copings and protective caps are indicated for temporary usage of up to 180 days (Ti, TAN, PEEK). Temporary copings made from PMMA are intended for temporary usage up to 30 days.

AI/ML Overview

The provided document describes the acceptance criteria and performance testing for the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps.

Here's the breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

Device Component	Acceptance Criteria	Reported Device Performance
NNC Solid Abutments	Function as intended; modifications do not impact performance.	"results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was specifically achieved through fatigue testing in accordance with FDA guidance.
NNC Temporary Copings	Function as intended; modifications do not impact performance.	"results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Temporary Copings... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was achieved through functional inspection and dimensional inspections.
NNC Protective Caps	Function as intended; modifications do not impact performance.	"results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Protective Caps... function as intended and met the pre-determined acceptance criteria." The device was found to be "substantially equivalent to the named predicate devices and are safe and effective for their intended use." This was achieved through functional inspection and dimensional inspections.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the exact sample sizes used for the performance tests (fatigue testing, functional inspection, dimensional inspections). It only states that "Verification and validation testing were performed." There is also no information provided regarding the data provenance (country of origin, retrospective/prospective). This type of detail is typically found in the full test reports, which are not included in this summary document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not available in the provided document. The performance testing described (fatigue testing, functional and dimensional inspections) are bench tests and do not typically involve human experts establishing ground truth in the way a clinical study or image interpretation study would.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable and not available in the provided document. Adjudication methods are relevant for studies where a panel of experts evaluates data (e.g., medical images) to establish a consensus ground truth. The tests performed here are mechanical and dimensional, not involving human interpretation or expert adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

There was no MRMC comparative effectiveness study done. This device is a dental implant component, not an AI-powered diagnostic or assistive tool. The performance testing focuses on the mechanical and functional integrity of the physical components.

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

This question is not applicable. The device is a physical medical device (dental implant components), not an algorithm or AI system. Therefore, standalone algorithm performance is not relevant.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

For the NNC Solid Abutments, the ground truth for performance was established by compliance with FDA guidance documents for fatigue testing. This guidance dictates specific testing methodologies and acceptance criteria for mechanical endurance.

For the NNC Temporary Copings and NNC Protective Caps, the ground truth was established through functional inspection and dimensional inspections. This means the ground truth was based on pre-defined specifications and expected functional behavior for the physical properties of the device.

In essence, the "ground truth" for these physical devices is their adherence to established engineering standards, material properties, and functional requirements.

8. The sample size for the training set

This information is not applicable and not available. This device is a physical medical device, not a machine learning model, so there is no concept of a "training set."

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

This information is not applicable. As there is no training set for a physical medical device, the establishment of its ground truth is irrelevant.

Summary

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K113410/51

JAN 1 3 2012

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 17, 2011

3. Name of the Device

Trade Name:	Straumann Narrow Neck CrossFit (NNC) SolidAbutments
	Straumann Narrow Neck CrossFit (NNC)
	Temporary Copings
	Straumann Narrow Neck CrossFit (NNC) Protective
	Caps
Common Name:	NNC Solid Abutments
	NNC Temporary Copings
	NNC Protective Caps
Classification Name:	Endosseous Dental Implant Abutments
Regulation Number:	§872.3630

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

Straumann Reqular Neck (RN) Solid Abutment. K894844

Straumann Narrow Connection (NC) Temporary Copings, and Straumann Narrow Connection (NC) Protective Caps, K080286

5. Description of the Device

December 22, 2011

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K113410/S1

6. Indications for Use

Prosthetic components directly connected to the endosseous dental implant are intended for use as an aid in prosthetic rehabilitations. The specific indications for use for each device table are specified in the table below.

	Indications for Use
Device type (as indicated on productlabel)	crown	bridge	Overdentures
Anatomic Abutment	×	×
Cementable Abutment
Solid abutment
synOcta® Milling Cylinder
synOcta abutment
Meso Abutment
Multi-Base Abutment		×	×
Coping, Ti
synOcta® 1.5 abutment	×	×	×
Temporary Abutment	×	×
Post for temporary restoration
Temporary Coping

Temporary abutments, copings and protective caps are indicated for temporary usage of up to 180 days (Ti, TAN, PEEK). Temporary copings made from PMMA are intended for temporary usage up to 30 days.

7. Technological Characteristics

The proposed devices are substantially equivalent to the currently marketed devices. They share the same indications for use, fundamental operating principles, and materials.

8. Performance Testing

Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments function as intended

December 22, 2011

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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 ll Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments."

Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Temporary Copings and the Straumann Narrow Neck Crossfit (NNC) Protective Caps function as intended and that the modifications do not impact the performance of the device. Temporary copings are placed out of occlusion. Protective caps do not support a restoration. Testing included:

1. Functional Inspection Test
1. Dimensional Inspections

9. Conclusion

The results from the testing conducted demonstrated that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps function as intended and met the pre-determined acceptance criteria.

The Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps is a validated system. The results of the performance bench testing and risk analysis indicate that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments, Temporary Copings, and Protective Caps are substantially equivalent to the named predicate devices and are safe and effective for their intended use.

Response Letter: K113410 Straumann NNC Solid Abutments December 22, 2011

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

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

JAN 1 3 2012

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

Re: K113410

Trade/Device Name: Straumann Narrow Neck CrossFit (NNC) Solid Abutments Straumann Narrow Neck CrossFit (NNC) Temporary Copings Straumann Narrow Neck CrossFit (NNC) Protective Caps Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: II Product Code: NHA Dated: December 22, 2011 Received: December 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 approvisions 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 Eederal 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 (roperails of increasts 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 Semprket 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/ResourcesforYou/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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K113410/S1

Indications for Use Statement

510(k) Number (if known):

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

Indications for Use:

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

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)

Sween Sumr

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number: K113410

Special 510(k) Submission: NNC Solid Abutments November 17, 2011

Page 14 of 86 Straumann USA

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K113410/s1

Indications for Use Statement

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Temporary Copings

Indications for Use:

Temporary Copings made from PEEK (polyether etherketone) are intended to serve as a base for temporary restorations for up to 180 days.

Temporary Copings made from PMMA (polymethyl methacrylate) are intended to serve as a base for temporary restorations for up to 30 days

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 CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital infection Control, Dental Devices

510(k) Number: k || 3410

Response Letter: K113410 Straumann NNC Solid Abutments December 22, 2011

Straumann, USA Page 20 of 24

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K113410/S1

Indications for Use Statement

510(k) Number (if known):

Device Name: Straumann Narrow Neck CrossFit (NNC) Protective Caps

Indications for Use:

Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.

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)

Page 1 of 1

(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

Special 510(k) Submission: NNC Solid Abutments November 17, 2011

Page 16 of 86 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.)