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 implants 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 Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Device Description

The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.

The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device.

A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion.

The endosseous dental implants are available in a range of endosseous diameters and lengths.

The abutments are available in different versions 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/nut construction and a metric thread.

The following types of abutments will be available:

. Cover screw
Healing abutment
Straight abutment ●
Alligator abutment

AI/ML Overview

The provided document is a 510(k) summary for a medical device called "Dental Implant System OKTAGON® Bone Level." It establishes substantial equivalence to predicate devices rather than providing a detailed study proving the device meets specific acceptance criteria in the way an AI/ML device would.

Therefore, many of the requested fields (like sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, training set details) are not applicable to this type of regulatory submission for a physical medical device.

However, I can extract information related to performance testing that serves as the basis for demonstrating safety and effectiveness relative to established standards.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria and Reported Device Performance

For this physical medical device, the "acceptance criteria" are the requirements outlined in the referenced international and national standards. The "reported device performance" is a statement of successful adherence to these standards.

Acceptance Criteria (Standard Requirements)	Reported Device Performance
ISO 14801: Fatigue testing requirements for dental implants.	Performance tests (fatigue tests) have been conducted, fulfilling the requirements of ISO 14801.
FDA's "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments": Specific guidance for this device type.	Performance tests have been conducted, fulfilling the requirements of the FDA's "Guidance..."
ISO 7405: Dental Materials - Evaluation of biocompatibility of medical devices used in dentistry.	Followed.
ISO 10993-1: Biological evaluation of medical devices (Part 1: Evaluation and testing within a risk management process).	Followed.
ISO 5832-2: Implants for surgery - Metallic materials - Part 2: Unalloyed titanium.	Followed (material: commercially pure Titanium Grade 4 conforming to ASTM F67).
ASTM F67: Standard Specification for Unalloyed Titanium for Surgical Implant Applications.	Followed (material: commercially pure Titanium Grade 4 conforming to ASTM F67).
ISO 11137-1, ISO 11137-2: Sterilization of health care products - Radiation (Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices; Part 2: Establishing the sterilization dose).	Followed.
ISO 14971: Medical devices - Application of risk management to medical devices.	Followed.
ISO 10993-5: Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.	Followed.
ANSI/AAMI ST79: Comprehensive guide to steam sterilization and sterility assurance in health care facilities.	Followed for sterilization validation of accessories.
ISO 11607-1:2009: Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems.	Followed.
ASTM F88/F88M-09: Standard Test Method for Seal Strength of Flexible Barrier Materials.	Followed.
ASTM F1929-98 (2004): Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration.	Followed.
ISO 5832-3: Implants for surgery - Metallic materials - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy.	Followed.
ASTM F136: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications.	Followed.
ISO 17665-1, ISO 17665-2: Sterilization of health care products - Moist heat (Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices; Part 2: Guidance on the application of ISO 17665-1).	Followed for sterilization validation for accessories.

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: Not specified in the document. The performance tests (fatigue tests) are likely conducted on a sample of devices according to the requirements of the specified standards (e.g., ISO 14801).
Data Provenance: Not specified. Standard performance testing is typically conducted in a laboratory setting, often by the manufacturer or a third-party testing facility. This is not "clinical data" in the sense of patient data.

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)

Not applicable. "Ground truth" in this context would refer to the established performance requirements outlined in the engineering and material standards. These are not established by clinical experts in the same way an AI/ML diagnostic output needs ground truth. Compliance to these standards is verified by testing engineers.

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

Not applicable. This concept pertains to resolving discrepancies in expert interpretations, primarily relevant for image-based diagnostic AI/ML. For a physical device, performance is measured against objective engineering metrics.

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

Not applicable. This is a physical dental implant system, not an AI/ML diagnostic or assistive tool.

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

Not applicable. This device does not involve an algorithm.

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

The "ground truth" here is the adherence to the engineering and material specifications defined by international standards (e.g., ISO 14801 for fatigue, ASTM F67 for material composition). These standards establish objective, measurable criteria for safety and performance.

8. The sample size for the training set

Not applicable. This device does not use machine learning, so there is no training set. Design validation and verification are based on engineering principles and regulatory standards.

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

Not applicable. As there is no training set, this question is not relevant.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure in profile, composed of three overlapping silhouettes. The silhouettes are arranged in a way that suggests movement or progress. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

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

August 31, 2015

Hager & Meisinger GmbH Mr. Wiebke Stolten Management Regulatory Affairs Hansemannstrasse 10 Neuss. 41468 GERMANY

Re: K143539 Trade/Device Name: Dental Implant System OKTAGON® Bone Level Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE, NHA Dated: July 30, 2015 Received: July 31, 2015

Dear Mr. 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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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 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,

in filmləri Kiang -S

for 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 Implant System OKTAGON® Bone Level

Section #4 Indications for Use Statement

510(k) Number (if known): K143539

Device Name: Dental Implant System OKTAGON® Bone Level

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 Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

Prescription Use X Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Part 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)

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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:

8th April 2015

3. Name of the device

Trade Name:	Dental Implant System OKTAGON® Bone Level
Common Name:	Endosseous dental implants and abutments
Classification Name:	Endosseous dental implants
Product Code:	DZE and NHA
Regulation No:	872.3640
Class:	II
Panel:	Dental

4. Predicate Devices:

510(k) No.	Manufacturer	Trade Name
K122807	Meisinger	Dental Implant OKTAGON
K062129	Straumann	P.004 Implant
K132214	Meisinger	Dental Abutment OKTAGON
K072071	Straumann	P.004 RC Cementable Abutments
K080286	Straumann	P.004 NC Cementable Abutments

5. Device Description:

The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.

The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in

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Section #5 510(k) Summary

the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched.

The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device.

A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion.

The endosseous dental implants are available in a range of endosseous diameters and lengths.

The following types of abutments will be available:

. Cover screw
Healing abutment
Straight abutment ●
Alligator abutment

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 Oktagon Bone Level System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.

7. Perfomance tests and used standards

Performance tests (fatigue tests) have been conducted, fulfilling the requirements of ISO 14801 and the FDA's "Guidance for Industry and FDA Staff - Class II Special

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Section #5 510(k) Summary

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

The following standards have been followed for the development, production, performance and safety testing of Dental Implant System OKTAGON® Bone Level: ISO 14801, ISO 7405, ISO 10993-1, ISO 5832-2, ASTM F67, ISO 11137-1, ISO 14971, ISO 11137-2, ISO 10993-5, ANSI/AAMI ST79, ISO 11607-1:2009, ASTM F88/F88M-09, ASTM F1929-98 (2004), ISO 5832-3, ASTM F136.

The following standards have been followed sterilization validation for the accessories: ISO 17665-1, ISO 17665-2.

8. Basis for substantial equivalence

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

Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann AG
510(k) Number	K143539	K122807	K062129
Intended Use	The implants are surgically placed inthe maxillary and/ or mandibular archesto provide support for prostheticrestorations in edentulous or partiallyedentulous patients.The parts are intended to be used withOKTAGON® Bone Level abutmentsand prosthetic parts.The Dental Implant OKTAGON®system Bone Level is intended fordelayed loading, or for immediateloading when good primary stability isachieved and with appropriate occlusalload.	The implants are surgically placed inthe maxillary and/ or mandibulararches to provide support forprosthetic restorations in edentulous orpartially edentulous patients.The parts are intended to be used withOKTAGON® abutments and prostheticparts.	The P.004 is intended forimmediate, delayed, orconventional placement inthe anterior maxillary an/ormandibular arches tosupport crowns, bridges oroverdentures in edentulousor partially edentulouspatients.
Description	The root-form designed implant ismade of commercially pure TitaniumGrade 4 conforming to ASTM StandardSpecification F67. The surface is micro-structured in the endosteal section andthe implant shoulder is polished. Theimplant surface has been blasted withhigh-grade corundum and afterwardsacid-etched.The prosthetic connection is achievedwith the help of an inner cone with anadditional octagonal anti-rotationdevice.	The Dental Endosseous ImplantOKTAGON® is a root-form designmade of commercially pure TitaniumGrade 4 conforming to ASTMStandard Specification F67. Thesurface is micro-structured in theendosteal section and the implantshoulder is polished. The implantsurface has been blasted with high-grade corundum and afterwards acid-etched.The prosthetic connection is achievedwith the help of an inner cone with an	The P.004 is an addition tothe currently distributedStraumann Dental ImplantSystem. The P.004 implantis a solid screw with a SLA(grit blasted then acidetched) or SLA surface. Theimplants are composed ofGrade 4 commercially pureTitanium and are available ina range of lengths anddiameters.

Overview Implants:

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Section #5 510(k) Summary

	A sterile locking screw is enclosed withthe implant so that an immediateocclusion of the internal thread isallowed after successfulinsertion.The endosseous dental implants areavailable in a range of endosseousdiameters and lengths.	additional octagonal anti-rotationdevice. A sterile locking screw isenclosed with the implant so that animmediate occlusion of the internalthread is allowed after successfulinsertion.The endosseous dental implants areavailable in a range of endosseousdiameters and lengths.
Material	Titanium Grade 4	Titanium Grade 4	Titanium Grade 4
Surfaceendosseous	Micro-structured (grit blasted and acidetched)	Micro-structured (grit blasted and acidetched)	grit blasted then acid etched
Length	8mm to 14mm endosseous length	8mm to 14mm endosseous length	8mm to 14mm endosseouslength
Diameter	3.3 to 4.8 mm endosseous	3.3 to 4.8 mm endosseous, Ø 6.5coronal (at 4.8mm endosseous)	3.3 to 4.8 mm endosseous

The implants have the same material composition and the same surface treatments. In addition, the implants are of the same, root-form design.

	Overview Abutments:
Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann AG	Straumann AG
510(k) Number	K143539	K132214	K072071	K080286
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.	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 are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and multiple tooth restorations.	Abutments are placed into dental implants to provide support for prosthetic restorations such as crowns, bridges and overdentures. Abutments can be used in single tooth replacements and 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	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	The Straumann P.004 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	The Straumann P.004 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

Overview Abutments:

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Section #5 510(k) Summary

Manufacturer	Hager & Meisinger GmbH	Hager & Meisinger GmbH	Straumann AG	Straumann AG
510(k) Number	K143539	K132214	K072071	K080286
	submission are abutments indifferent version includingthe corresponding screws.	covered in this submissionare abutments.	system consists of avariety of dentalimplants, abutments andsurgical and prostheticparts and instruments.	system consists of avariety of dentalimplants, abutments andsurgical and prostheticparts and instruments.
Material	Titanium Grade 4, TitaniumAlloy, synthetic material	Titanium Grade 4,Titanium Alloy, syntheticmaterial	Not detailed insubmission, acc. tocatalogue same materialused	Not detailed insubmission, acc. tocatalogue same materialused

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 System OKTAGON® Bone Level is substantially equivalent to the legally marketed predicate devices described.

Regulation Number and Section

§ 872.3640 Endosseous dental implant.

(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. 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.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.