K Number

Device Name

NNC SOLID ABUTMENT NNC TEMPORARY COPING FOR COLID ABUTMENT NNC TEMPORARY CAP FOR COLID ABUTMENT

Manufacturer

STRAUMANN USA

Date Cleared

2012-01-13

(56 days)

Product Code

NHA

Regulation Number

872.3630

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 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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K894844, K080286

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes dental abutments and related components, which are mechanical devices. There is no mention of software, algorithms, or any technology that would suggest the use of AI or ML. The performance studies focus on mechanical fatigue and functional/dimensional inspections.

Therapeutic

No.

The device, described as abutments, temporary copings, and protective caps, is intended for prosthetic restoration and support of dental implants, and not for treating a disease or therapeutic purpose.

Diagnostic

No
The device is described as an abutment used for prosthetic restoration in dental implants, providing support for crowns and bridges. Its function is to facilitate the connection between the implant and the prosthesis, not to diagnose medical conditions or diseases.

SaMD (Software as a Medical Device)

The device description explicitly states the device is made of Titanium Grade 4 and describes physical components like abutments, copings, and protective caps. The performance studies involve physical testing like fatigue testing and dimensional inspections.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly describes the device as being used in connection with prosthetic restoration of dental implants, providing support for crowns and bridges. This is a mechanical and structural function within the body.
Device Description: The description details the materials (Titanium Grade 4, PEEK, PMMA) and the physical components (abutments, copings, caps) used in dental procedures.
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) to provide information for diagnosis, monitoring, or screening. The device itself is implanted or used directly in the mouth for structural support.

Therefore, this device falls under the category of a medical device used for dental restoration, not an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Device type (as indicated on product label)	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.

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.

Product codes (comma separated list FDA assigned to the subject device)

NHA

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Verification and validation testing were performed to ensure that the Straumann Narrow Neck CrossFit (NNC) Solid Abutments function as intended and that the modifications do not impact the performance of the device. Testing included:

Performance Testing
- 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:

Functional Inspection Test
Dimensional Inspections

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K894844, K080286

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.)

Summary

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) Solid
Abutments |
|----------------------|---------------------------------------------------------|
| | 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

K113410/S1

6. Indications for Use

	Indications for Use
Device type (as indicated on product
label)	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

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."

1. Functional Inspection Test
1. Dimensional Inspections

9. Conclusion

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

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.

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

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

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

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