Dental Implant Abutments Bone Level 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 Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Device Description

The Dental Implant System OKTAGON® Bone Level 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 angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.

AI/ML Overview

This document is a 510(k) Summary for the Endosseous Dental Implant Abutments OKTAGON® Bone Level. It focuses on demonstrating substantial equivalence to predicate devices rather than proving device performance against specific acceptance criteria for a novel device. Therefore, much of the requested information about acceptance criteria, study sizes, expert involvement, and ground truth types for AI/ML device studies is not applicable or not present in this document.

However, based on the provided text, here's what can be extracted and inferred:

1. A table of acceptance criteria and the reported device performance

Since this is a submission for substantial equivalence based on predicate devices, explicit "acceptance criteria" for novel device performance are not listed in a quantifiable table as they would be for a new technology with specific performance claims. Instead, the "acceptance criteria" are implied by adherence to recognized standards and similarity to predicate devices.

Acceptance Criterion (Implied)	Reported Device Performance
Mechanical Performance (Fatigue and Breakage)	Complies with ISO 14801 and the FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments". Performance tests (breakage and fatigue tests) have been conducted and fulfilled requirements.
Biocompatibility	Evaluated according to ISO 10993-1. The subject device is comparable in intended use, design, and materials to legally marketed predicate devices. No known negative biological effects of dental implants made of Titanium Grade 4. Requirements of ISO 10993-1 are fulfilled.
Sterilization Validation	Complies with ISO 17665-1, ISO 17665-2, and ANSI/AAMI ST 79.
Material Specification	Complies with ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3. (Materials are Titanium Grade 4 and Titanium Alloy - TiAl6V4).
Risk Management	Complies with ISO 14971.
Intended Use Equivalence to Predicate Devices	Identical to the named predicate devices. (Dental Implant Abutments Bone Level are intended to provide support for prosthetic reconstructions, compatible with specific OKTAGON® Bone Level implants and diameters/lengths).
Material Composition Equivalence to Predicate Devices	Identical (Titanium Grade 4 for abutments; Titanium Alloy (TiAl6V4) for alligator abutments and screws).
Connection to Implants Equivalence to Predicate Devices	Equivalent (internal octagon/nut construction and a metric thread for abutments; conical, fixating by screw for Alligator Abutments).
Principal Design and Measurements Equivalence to Predicate Devices	Identical (variations in angled abutments Ø3.5mm L 6.0mm, H 1.5/3.0mm; angled alligator abutments H 3.0/4.0mm; angled abutments Ø5.0mm L 8.0mm, H 1.5/3.0mm; angled alligator abutments H 3.0/4.0mm, with 18°/15° angulation; similar to predicate dimensions shown in the tables on pages 8-9).

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

Sample Size for Test Set: Specific sample sizes for the mechanical and biocompatibility tests are not disclosed in this summary. The document states that "performance tests (breakage and fatigue tests) have been conducted," but does not provide the number of units tested.
Data Provenance: Not specified. The manufacturer is Hager & Meisinger GmbH, located in Neuss, Germany. Testing was likely conducted in Germany or by certified labs.
Retrospective or Prospective: Not specified, but typically, these types of laboratory tests for medical devices are conducted prospectively under controlled conditions.

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 applicable to this type of device submission. The device is a physical dental implant abutment, and its performance is evaluated through standardized material and mechanical testing, not through expert review of data like an AI/ML diagnostic device.

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

This information is not applicable to this type of device submission. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in evaluating clinical data or outputs of AI/ML systems where subjective interpretation might be involved. The testing here involves objective measurements against engineering standards.

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

This information is not applicable to this type of device submission. MRMC studies are relevant for diagnostic devices, particularly those involving human interpretation enhanced by AI. This device is a physical implant component.

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

This information is not applicable to this type of device submission. This device does not involve an algorithm.

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

The "ground truth" for this device's performance is based on established engineering and medical device standards. For example:
- Mechanical Integrity: ISO 14801 (Fatigue Testing) and the FDA's Class II Special Controls Guidance document for dental implants.
- Biocompatibility: ISO 10993-1, ISO 7405, ISO 10993-5.
- Sterilization: ISO 17665-1, ISO 17665-2, ANSI/AAMI ST 79.
- Materials: ASTM F136, ASTM F67, ISO 5832-2, ISO 5832-3.
- The "ground truth" is adherence to these normative standards and comparison to the characteristics of legally marketed predicate devices.

8. The sample size for the training set

This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

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

This information is not applicable as this device does not involve a training set for an AI/ML algorithm.

Summary

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

November 21, 2016

Hager & Meisinger GmbH Dr. Melanie May Regulatory Affairs Hansemannstrasse 10 Neuss. 41468 Germany

Re: K160132

Trade/Device Name: Endosseous Dental Implant Abutments OKTAGON® Bone Level Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 20, 2016 Received: October 20, 2016

Dear Dr. Melanie May:

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.

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Michael J. Ryan -S

for Tina Kiang, Ph.D. Acting 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K160132

Device Name

Endosseous Dental Implant Abutments OKTAGON® Bone Level

Indications for Use (Describe)

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

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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- 223 Contact Person: Dr. Melanie May Product approval and product validation (Regulatory Affairs)

2. Date prepared

Date prepared:

November 17th, 2016

Endosseous Dental Implant Abutments

3. Name of the device

Trade Name:

	OKTAGON® Bone Level
Common Name:	Endosseous dental implant abutments
Classification Name:	Endosseous dental implant abutment
Product Code:	NHA
Regulation No:	872.3630
Class:	II
Panel:	Dental

4. Predicate Devices:

PredicateDevice	510(k)No.	Manufacturer	Trade Name
PrimaryPredicate	K143539	Meisinger	Dental Endosseous ImplantSystem OKTAGON® BoneLevel
ReferencePredicate	K132214	Meisinger	Dental AbutmentOKTAGON®

5. Device Description:

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510(k) Summary

The Dental Implant System OKTAGON® Bone Level 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 angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.

The abutments are available in the following variations including the corresponding screws:

ArticleNo.	Variation	Description	Material		Connection toImplant	IntendedUse
			Abutment	Screw
22025	NC	Abutment, Angled, 18°,Ø3.5mm, L 6.0 mm,H1.5mm, cementable, incl.basic screw 22030	TitaniumGrade 4	TitaniumAlloy(TiAl6V4)	Octagonal,fixating byscrew	For crownsand bridges
22026	NC	Abutment, Angled, 18°,Ø3.5mm, L 6.0 mm,H3.0mm, cementable, 22030	TitaniumGrade 4	TitaniumAlloy(TiAl6V4)	Octagonal,fixating byscrew	For crownsand bridges
22030	NC	Basic screw for NC abutment	TitaniumAlloy(TiAl6V4)	-		For use withabutments
22041	NC	Alligator Abutment Angled,15°, H3.0mm	TitaniumAlloy(TiAl6V4)	-	Conical,fixating byscrew	OverdentureProsthetic
22042	NC	Alligator Abutment Angled,15°, H4.0mm	TitaniumAlloy(TiAl6V4)	-	Conical,fixating byscrew	OverdentureProsthetic
22103	RC	Abutment, Angled, 18°,Ø5.0mm, L 8.0 mm,H1.5mm, cementable,	TitaniumGrade 4	TitaniumAlloy(TiAl6V4)	Octagonal,fixating byscrew	For crownsand bridges
22105	RC	Abutment, Angled, 18°,Ø5.0mm, L 8.0 mm,H3.0mm, cementable, incl.basic screw 22122	TitaniumGrade 4	TitaniumAlloy(TiAl6V4)	Octagonal,fixating byscrew	For crownsand bridges

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510(k) Summary

ArticleNo.	Variation	Description	Material		Connection toImplant	IntendedUse
			Abutment	Screw
22122	RC	Basic screw for RC abutment	TitaniumAlloy(TiAl6V4)	-	-	For use withabutments
22129	RC	Alligator Abutment Angled,15°, H3.0mm	TitaniumAlloy(TiAl6V4)	-	Conical,fixating byscrew	OverdentureProsthetic
22130	RC	Alligator Abutment Angled,15° H4.0mm	TitaniumAlloy(TiAl6V4)	-	Conical,fixating byscrew	OverdentureProsthetic
22131	RC/NC	Basic Screw for Alligator	TitaniumAlloy(TiAl6V4)	-	-	OverdentureProsthetic

6. Indications for use:

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

The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

7. Performance tests and used standards

The following standards have been followed for the development, production, performance and safety testing of Dental Implant Abutment OKTAGON® Bone Level:

Fatigue Testing according to ISO 14801
Evaluation of Biocompatibility according to ISO 10993-1, ISO 7405 .
Cytotoxicity Testing according to ISO 10993-5 .

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510(k) Summary

. Sterilization validation according to ISO 17665-1, ISO 17665-2 and ANSI/ AAMI ST 79
Material Specification according to ASTM F136, ASTM F67, ISO 5832-. 2, ISO 5832-3
Risk Management according to ISO 14971 ●

In order to demonstrate substantial equivalence performance tests (breakage and fatigue tests) have been conducted, fulfilling the requirements of ISO 14801 and the FDA's "Guidance for Industry and FDA Staff – Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".

The biocompatibility was evaluated according to ISO 10993-1. The evaluation shows, that the subject device is comparable in intended use, design and materials to the legally market predicate devices. There are no known negative biological effects of dental implants made of Titanium Grade 4. Thus the requirements of ISO 10993-1 are fulfilled.

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510(k) Summary

8. Basis for substantial equivalence

The intended use for Dental Implant Abutment OKTAGON® Bone Level is identical to the named predicated devices.

Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Hager & Meisinger GmbH
510(k) Number	Subject device K160132	Primary Predicate K143539	Reference Predicate K132214
Indications for Use	Dental Implant Abutments Bone Level 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 Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.	The implants are surgically placed in the maxillary and/ or mandibular arches to provide support for prosthetic restorations in edentulous or partially edentulous patients. The parts are intended to be used with OKTAGON® Bone Level abutments and prosthetic parts.Dental Implant Abutments Bone Level 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 Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and 4.8mm and with the lengths 8mm, 10mm, 12mm and 14mm.The Dental Implant OKTAGON® system Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.	Abutments are intended to be placed into dental implants 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.
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 versions including the	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 versions including the	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.

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510(k) Summary

Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Hager & Meisinger GmbH
510(k) Number	Subject device K160132	Primary Predicate K143539	Reference Predicate K132214
	corresponding screws.	corresponding screws.
Diameter, Length (L), Height (H)	Variation NC:	Variation NC:	Abutments:
	Angled abutments:	Abutments:	Ø2.5-4.8, L= 1.5 - 7.0 mm,
	Ø3.5, L= 6 mm, H = 1.5 mm and 3.0 mm	Ø3.5, L= 6 mm, H = 1.0 mm, 2.0, 3.0 and 3.5 mm	Alligator Abutments:
	Alligator abutments:	Alligator abutments:	H = 1.0, 1.5, 2.0, 3.0 and 4.0 mm
	H = 3.0 mm and 4.0 mm	H = 2.0, 3.0, 4.0 and 5.0 mm
	Variation RC:	Variation RC:
	Angled abutments:	Abutments:
	Ø5.0 mm, L= 8.5 mm, H = 1.5 mm and 3.0 mm	Ø5.0 and 6.5, L= 8.5 mm, H = 1.0, 2.0 and 3.0 mm
	Alligator abutments:	Alligator abutments:
	H = 3.0 mm and 4.0 mm	H = 1.0, 2.0, 3.0, 4.0 and 5.0 mm
Angulation	18° for Abutments, 15° for angled Alligator	0° for Abutments, 15° for angled Alligator	Max. 20°
Material	Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws)	Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws), synthetic material (plastic copings made of POM)	Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws), synthetic material (plastic copings made of POM)

The intended use for Abutments 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 these observations, we conclude that the Dental Implant Abutment OKTAGON® Bone Level is substantially equivalent to the legally marketed predicate devices described.

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.)