Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations.

The Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.

Device Description

The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon and a metric thread.

AI/ML Overview

Here is an analysis of the provided text regarding the acceptance criteria and study for the "Dental Endosseous Implant Abutment OKTAGON®":

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Device Performance (as reported)
Fulfills requirements of ISO 14801 (Fatigue Test for Endosseous Dental Implants)	"The performed test fulfills the requirements listed in ISO 14801"
Fulfills requirements of "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8"	"The performed test fulfills... the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8."
Substantial Equivalence to Predicate Devices: - Identical intended use - Equivalent material composition - Equivalent connection to implants - Identical principal design and measurements	"The intended use for Endosseous Dental Implant Abutment OKTAGON® is identical to the named predicated devices. The abutments have the same indications for use, material composition and the connection to implants is equivalent. In addition the principal design including measurements of abutments is identical to the previously cleared predicated devices."

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

The provided text only explicitly mentions a "performance test (fatigue test)" conducted for the Dental Implant Abutments OKTAGON®. It does not specify a separate "test set" in the context of a statistical study with a specific sample size. The fatigue test itself would involve a sample of the abutments, but the exact number is not detailed.

Sample Size for Test Set: Not explicitly stated for the fatigue test.
Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.

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

This information is not applicable to the submission for a dental implant abutment, as the evaluation relies on physical performance testing against established engineering standards (ISO 14801) and comparison with predicate devices, rather than expert interpretation of medical images or clinical outcomes.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as in point 3.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for AI/CAD systems that assist human readers in tasks like image interpretation, which is not relevant for a dental implant abutment.

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

No, a standalone (algorithm only) performance study was not done. The device is a physical medical device (dental implant abutment), not an algorithm or AI system. Its performance is evaluated through physical tests like fatigue testing, not computational algorithms.

7. The Type of Ground Truth Used

For the fatigue test, the "ground truth" would be the objective mechanical properties and failure criteria defined by the ISO 14801 standard and the FDA's special controls guidance document. The abutments' ability to withstand specified cyclic loading without failure to a certain threshold is measured against these established engineering benchmarks.

For the substantial equivalence claim, the "ground truth" is the characteristics (intended use, material, connection, design, measurements) of the legally marketed predicate devices, which the OKTAGON® abutment is compared against.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical medical device, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device is a physical medical device and does not utilize a training set or machine learning.

Summary

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JUL 07 2014

510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®

Section #5 510((k) Summary

1. Applicant's Name and Address

Hager & Meisinger GmbH Hansemannstraße 10 41468 Neuss, Germany Phone: (0049) 2131 2012-0 Fax: (0049) 2131 2012- 222 Contact Person: Wiebke Stolten

Management product approval and product validation (Regulatory Affairs)

2. Date prepared

Date prepared:

06/11/2014

3. Name of the device

Trade Name: Common Name: Classification Name: Product Code: Regulation No: Class: Panel:

Dental Implant Abutment OKTAGON® Endosseous dental implant abutments Endosseous dental implant abutment NHA 872.3630 . ll Dental

4. Predicate Devices:

510(k No.)	Manufacturer	Trade Name
K091701	Straumann	Dental Abutment (Modified DentalImplant Abutment)
K073628	Straumann	Abutment, Dental, Endosseousimplants (RN synOcta 1.5 mm Abutment

5. Device Description:

Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional ·

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510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®

Section #5 510(k) Summary

The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the ' connection to the implants is achieved by an internal octagon and a metric thread.

6. Indications for use:

Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations.

7. Performance tests and used standards / Clinical data

For Dental Implant Abutments OKTAGON® a performance test (fatigue test) has been conducted.

The performed test fulfills the requirements listed in ISO 14801 and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8. The following standards have been considered for Dental Implant Abutments OKTAGON® during development, production and market surveillance: ISO 14801, ISO 7405, ISO 10993-1, ISO 5832-2, ASTM F67, ISO 14971, ISO 5832-3, ASTM F136. AAMI ST79. ISO 17665-1.

Manufacturer	Hager & MeisingerGmbH	Straumann AG	Straumann AG
510(k) Number	K132214	K091701	K073628
Indications for Use	Abutments are intended to beplaced into dental implants toprovide support for prostheticreconstructions. Prostheticapplications can includeindividual crowns, bridges,partial or total prostheses.	Abutments are placed intodental implants to providesupport for prostheticrestorations such as crownsand bridges.Abutments can be used insingle tooth replacements and	Abutments are placed intodental implants to providesupport for prostheticrestorations such as crownsand bridges.Abutments can be used insingle tooth replacements and

8. Basis for substantial equivalence

Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional

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510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®

Section #5 510(k) Summary

Manufacturer	Hager & Meisinger GmbH	Straumann AG	Straumann AG
510(k) Number	K132214	K091701	K073628
	Abutments can be used in single tooth replacements and multiple tooth restorations.	multiple tooth restorations.	multiple tooth restorations.
Description	The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws.	The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments.	The Straumann Dental Implant System is an integrated system of endosseous dental implants, which are designed to support prosthetic devices for partially or fully edentulous patients. The system consists of a variety of dental implants, abutments and surgical and prosthetic parts , and instruments. The device covered in this submission is an abutment.The coronal portion of the abutment is seated in the implant with a screw. The abutment is used for screw-retained and cemented restorations.
Material	Titanium Grade 4, Titanium Alloy, synthetic material	Not detailed in submission, acc. to catalogue same material used	Not detailed in submission, acc. to catalogue same material used
Connection	octagonal anti-rotation device	octagonal anti-rotation device	octagonal anti-rotation device

The intended use for Endosseous Dental Implant Abutment OKTAGON® is identical to the named predicated devices. The abutments have the same indications for use, material composition and the connection to implants is equivalent. In addition the principal design including measurements of abutments is identical to the previously cleared predicated devices.

Based on the information provided in the summary, we conclude Dental Implant Abutments OKTAGON® are substantially equivalent to the legally marketed predicate devices described.

(

Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three legs, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

July 7, 2014

Hager & Meisinger GMbh Ms. Wiebke Stolten Management, Regulatory Affairs Hansemannstrasse 10 Neuss, D-41468 GERMANY

Re: K132214

Trade/Device Name: Dental Implant Abutment OKTAGON® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implants abutment Regulatory Class: II Product Code: NHA Dated: June 2, 2014 Received: June 3, 2014

Dear Ms. Stolten:

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. Stolten

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 practice requirements as set forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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,

MaryDner-S

Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®

Section #4 Indications for Use Statement

510(k) Number (if known): K132214

Device Name: Dental Implant Abutment OKTAGON®

Indications for use:

Dental Implant Abutments are intended to provide support for prosthetic reconstructions. Prosthetic applications can include individual crowns, bridges, partial or total prostheses.

Abutments can be used in single tooth replacements and multiple tooth restorations.

Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Page 4.1

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.)