← Product Code [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE) · K143539 # Dental Implant OKTAGON Bone Level (K143539) _Hager& Meisinger GmbH · DZE · Aug 31, 2015 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K143539 ## Device Facts - **Applicant:** Hager& Meisinger GmbH - **Product Code:** [DZE](/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE.md) - **Decision Date:** Aug 31, 2015 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.3640 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Intended Use 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 Story Root-form dental implant system; surgically placed in maxillary/mandibular arches; provides support for prosthetic restorations (crowns, bridges, overdentures). Composed of Titanium Grade 4; micro-structured surface (grit-blasted/acid-etched); internal cone connection with octagonal anti-rotation device. Includes locking screw for internal thread occlusion. Used by dental clinicians in clinical settings. Supports delayed or immediate loading (if primary stability achieved). Benefits patients by restoring dental function and aesthetics. ## Clinical Evidence Bench testing only. Fatigue testing conducted per ISO 14801. No clinical data presented. ## Technological Characteristics Root-form endosseous dental implants and abutments. Materials: Titanium Grade 4 (ASTM F67), Titanium Alloy, POM. Surface: grit-blasted and acid-etched. Connection: internal cone with octagonal anti-rotation. Standards: ISO 14801, ISO 7405, ISO 10993-1, ISO 5832-2/3, ASTM F67/F136/F88/F1929, ISO 11137-1/2, ISO 14971, ISO 10993-5, ANSI/AAMI ST79, ISO 11607-1, ISO 17665-1/2. ## Regulatory 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. ## Special Controls *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. ## Predicate Devices - Dental Implant OKTAGON ([K122807](/device/K122807.md)) - P.004 Implant ([K062129](/device/K062129.md)) - Dental Abutment OKTAGON ([K132214](/device/K132214.md)) - P.004 RC Cementable Abutments ([K072071](/device/K072071.md)) - P.004 NC Cementable Abutments ([K080286](/device/K080286.md)) ## Related Devices - [K162073](/device/K162073.md) — Dental Implants OKTAGON Tissue Level and Bone Level · Hager& Meisinger GmbH · Feb 24, 2017 - [K070007](/device/K070007.md) — SPI ELEMENT PLATFORM O 4.0 MM · Thommen Medical AG · Jan 10, 2007 - [K193401](/device/K193401.md) — Altatec GmbH CAMLOG/CONELOG PROGRESSIVE-LINE Implants · Altatec GmbH · Sep 29, 2020 - [K120503](/device/K120503.md) — CMI IMPLANT IS II ACTIVE · Neobiotech Co., Ltd. · Jun 18, 2012 - [K101225](/device/K101225.md) — PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 8.5 MM MODEL 03-1001, PROMIMIC DENTAL IMPLANT, 3.75 MM, LENGTH 10 MM MODEL 03-1 · Promimic AB · Jan 25, 2011 ## Submission Summary (Full Text) {0}------------------------------------------------ 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. {1}------------------------------------------------ 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 {2}------------------------------------------------ ### 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: 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. 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) {3}------------------------------------------------ ## 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 {4}------------------------------------------------ ## 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 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 ### 6. Indications for use: 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. #### 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 {5}------------------------------------------------ ## 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 in<br>the maxillary and/ or mandibular arches<br>to provide support for prosthetic<br>restorations in edentulous or partially<br>edentulous patients.<br>The parts are intended to be used with<br>OKTAGON® Bone Level abutments<br>and prosthetic parts.<br><br>The Dental Implant OKTAGON®<br>system Bone Level is intended for<br>delayed loading, or for immediate<br>loading when good primary stability is<br>achieved and with appropriate occlusal<br>load. | The implants are surgically placed in<br>the maxillary and/ or mandibular<br>arches to provide support for<br>prosthetic restorations in edentulous or<br>partially edentulous patients.<br>The parts are intended to be used with<br>OKTAGON® abutments and prosthetic<br>parts. | The P.004 is intended for<br>immediate, delayed, or<br>conventional placement in<br>the anterior maxillary an/or<br>mandibular arches to<br>support crowns, bridges or<br>overdentures in edentulous<br>or partially edentulous<br>patients. | | Description | The root-form designed implant is<br>made of commercially pure Titanium<br>Grade 4 conforming to ASTM Standard<br>Specification F67. The surface is micro-<br>structured in the endosteal section and<br>the implant shoulder is polished. The<br>implant surface has been blasted with<br>high-grade corundum and afterwards<br>acid-etched.<br>The prosthetic connection is achieved<br>with the help of an inner cone with an<br>additional octagonal anti-rotation<br>device. | The Dental Endosseous Implant<br>OKTAGON® is a root-form design<br>made of commercially pure Titanium<br>Grade 4 conforming to ASTM<br>Standard Specification F67. The<br>surface is micro-structured in the<br>endosteal section and the implant<br>shoulder is polished. The implant<br>surface has been blasted with high-<br>grade corundum and afterwards acid-<br>etched.<br>The prosthetic connection is achieved<br>with the help of an inner cone with an | The P.004 is an addition to<br>the currently distributed<br>Straumann Dental Implant<br>System. The P.004 implant<br>is a solid screw with a SLA<br>(grit blasted then acid<br>etched) or SLA surface. The<br>implants are composed of<br>Grade 4 commercially pure<br>Titanium and are available in<br>a range of lengths and<br>diameters. | Overview Implants: {6}------------------------------------------------ ## Section #5 510(k) Summary | | A sterile locking screw is enclosed with<br>the implant so that an immediate<br>occlusion of the internal thread is<br>allowed after successful<br>insertion.<br>The endosseous dental implants are<br>available in a range of endosseous<br>diameters and lengths. | additional octagonal anti-rotation<br>device. A sterile locking screw is<br>enclosed with the implant so that an<br>immediate occlusion of the internal<br>thread is allowed after successful<br>insertion.<br>The endosseous dental implants are<br>available in a range of endosseous<br>diameters and lengths. | | |-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------| | Material | Titanium Grade 4 | Titanium Grade 4 | Titanium Grade 4 | | Surface<br>endosseous | Micro-structured (grit blasted and acid<br>etched) | Micro-structured (grit blasted and acid<br>etched) | grit blasted then acid etched | | Length | 8mm to 14mm endosseous length | 8mm to 14mm endosseous length | 8mm to 14mm endosseous<br>length | | Diameter | 3.3 to 4.8 mm endosseous | 3.3 to 4.8 mm endosseous, Ø 6.5<br>coronal (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.<br><br>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: {7}------------------------------------------------ ### 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 in<br>different version including<br>the corresponding screws. | covered in this submission<br>are abutments. | system consists of a<br>variety of dental<br>implants, abutments and<br>surgical and prosthetic<br>parts and instruments. | system consists of a<br>variety of dental<br>implants, abutments and<br>surgical and prosthetic<br>parts and instruments. | | Material | Titanium Grade 4, Titanium<br>Alloy, synthetic material | Titanium Grade 4,<br>Titanium Alloy, synthetic<br>material | Not detailed in<br>submission, acc. to<br>catalogue same material<br>used | Not detailed in<br>submission, acc. to<br>catalogue same material<br>used | 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. --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K143539](https://fda.innolitics.com/submissions/DE/subpart-d%E2%80%94prosthetic-devices/DZE/K143539) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. 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