(212 days)
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® respectively Bone Level abutments and prosthetic parts.
The OKTAGON Implant System is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.
The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.
Subject to this submission are the following implant variations:
BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm
TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm
TL RP Conical Ø4.1 mm, L 10 mm
The provided text is a 510(k) summary for a medical device (Dental Implants OKTAGON® Tissue Level and Bone Level). It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.
However, it does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in terms of algorithm performance for an AI/ML powered device. The "performance tests" mentioned refer to fatigue tests against ISO 14801 for mechanical properties of dental implants, not AI/ML algorithm evaluation.
Therefore, I cannot extract the requested information as it does not exist within the provided document.
To be explicit, the following information is not present in the document:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth.
- Adjudication method for the test set.
- Multi-reader multi-case (MRMC) comparative effectiveness study.
- Standalone (algorithm only) performance study.
- Type of ground truth used (for an AI/ML algorithm).
- Sample size for the training set.
- How ground truth for the training set was established.
This document pertains to the regulatory submission for a physical medical device (dental implants), not a software-as-a-medical-device (SaMD) or an AI/ML-powered medical device.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 24, 2017
Hager & Meisinger GmbH Melanie May Regulatory Affairs Hansemannstrasse 10 Neuss. 41468 GERMANY
Re: K162073
Trade/Device Name: Dental Implants OKTAGON Tissue Level and Bone Level Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE Dated: January 31, 2017 Received: February 3, 2017
Dear 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.
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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Indications for Use Statement
510(k) Number (if known): K162073
Dental Implants OKTAGON® Tissue Level Device Name: and 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 parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.
The OKTAGON Implant 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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K162073
1. Applicant's Name and Address
| Contact Person: | Dr. Melanie MayRegulatory Affairs | |
|---|---|---|
| Phone No.:Fax No.:Email: | +49 2131 2012 292+49 2131 2012 223melanie.may@meisinger.de | |
| Hager & Meisinger GmbHHansemannstrasse 10 |
41468 Neuss Germany
2. Date prepared
February 22nd, 2017 Date prepared:
3. Name of the device
| Trade Name: | Dental Implants OKTAGON® Tissue Level and Bone Level |
|---|---|
| Common Name: | Endosseous dental implants |
| Classification Name: | Endosseous dental implants |
| Product Code: | DZE |
| Regulation No: | 872.3640 |
| Class: | II |
| Panel: | Dental |
4. Predicate Devices
| 510(k) No. | Manufacturer | Trade Name |
|---|---|---|
| K122807(Primary Predicate Device) | Hager & Meisinger GmbH | Dental Implant OKTAGON® |
| K143539(Reference Predicate Device) | Hager & Meisinger GmbH | Dental Implant SystemOKTAGON® Bone Level |
5. Device Description
The Dental Implants OKTAGON® Tissue Level and Bone Level follow a root-form design and are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is microstructured in the endosteal section and the surface has been blasted with high-grade corundum and afterwards acid-etched. The implant shoulder of Dental Implants OKTAGON® Tissue Level and Bone Level is polished.
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510(k) Summary
The prosthetic connection is achieved with the help of an inner cone with an additional octagonal antirotation device. A sterile cover screw is enclosed with the implant so that an immediate occlusion of the internal thread is possible after successful insertion.
Subject to this submission are the following implant variations:
BL NC Ø3.75 mm, L 8 mm BL NC Ø3.75 mm, L 10 mm BL NC Ø3.75 mm, L 12 mm
TL RP Ø3.75 mm, L 8 mm TL RP Ø3.75 mm, L 10 mm TL RP Ø3.75 mm, L 12 mm
TL RP Conical Ø4.1 mm, L 10 mm
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 parts are intended to be used with OKTAGON® respectively Bone Level abutments and prosthetic parts.
The OKTAGON Implant System 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
Performance tests (fatique 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 following standards have been followed for the development, production, performance and safety testing of Dental Implants OKTAGON®: 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).
The following standards have been followed sterilization for the accessories: ISO 17665-1, ISO 17665-2.
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8. Technological Characteristics
| Manufacturer | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH |
|---|---|---|---|
| 510(k) Number | K162073 | K122807 | K143539 |
| (Primary Predicate Device) | (Reference Predicate Device) | ||
| Intended Use | The implants are surgicallyplaced in the maxillary and/ormandibular arches to providesupport for prostheticrestorations in edentulous orpartially edentulous patients.The parts are intended to beused with OKTAGON®respectively Bone Levelabutments and prosthetic parts.The OKTAGON® ImplantSystem is intended for delayedloading, or for immediateloading when good primarystability is achieved and withappropriate occlusal load. | The implants are surgicallyplaced in the maxillary and/ormandibular arches to providesupport for prostheticrestorations in edentulous orpartially edentulous patients.The implants are intended to beused with OKTAGON®abutments and prosthetic parts. | The implants are surgicallyplaced in the maxillary and/ormandibular arches to providesupport for prostheticrestorations in edentulous orpartially edentulous patients.The parts are intended to beused with OKTAGON® BoneLevel abutments and prostheticparts.The Dental Implant systemOKTAGON® Bone Level isintended for delayed loading, orfor immediate loading whengood primary stability isachieved and with appropriateocclusal load. |
| Implant | BL NC Ø3.75 mm, L 8 mm | TL RP Ø3.3 mm, L 8 mm | BL NC Ø3.3 mm, L 8 mm |
| Variations | BL NC Ø3.75 mm, L 10 mm | TL RP Ø3.3 mm, L 10 mm | BL NC Ø3.3 mm, L 10 mm |
| BL NC Ø3.75 mm, L 12 mm | TL RP Ø3.3 mm, L 12 mmTL RP Ø3.3 mm, L 14 mm | BL NC Ø3.3 mm, L 12 mmBL NC Ø3.3 mm, L 14 mm | |
| TL RP Ø3.75 mm, L 8 mm | |||
| TL RP Ø3.75 mm, L 10 mm | TL RP Ø4.1 mm, L 8 mm | BL RC Ø4.1 mm, L 8 mm | |
| TL RP Ø3.75 mm, L 12 mm | TL RP Ø4.1 mm, L 10 mm | BL RC Ø4.1 mm, L 10 mm | |
| TL RP Conical Ø4.1 mm, L 10mm | TL RP Ø4.1 mm, L 12 mm | BL RC Ø4.1 mm, L 12 mm | |
| TL RP Ø4.1 mm, L 14 mm | BL RC Ø4.1 mm, L 14 mm | ||
| TL RP Ø4.8 mm, L 8 mm | BL RC Ø4.8 mm, L 8 mm | ||
| TL RP Ø4.8 mm, L 10 mm | BL RC Ø4.8 mm, L 10 mm | ||
| TL RP Ø4.8 mm, L 12 mm | BL RC Ø4.8 mm, L 12 mm | ||
| TL RP Ø4.8 mm, L 14 mm | BL RC Ø4.8 mm, L 14 mm | ||
| TL RP TD Ø4.1 mm, L 10 mmTL RP TD Ø4.1 mm, L 12 mm | |||
| TL WP Ø4.8 mm, L 8 mmTL WP Ø4.8 mm, L 10 mmTL WP Ø4.8 mm, L 12 mm | |||
| Accessories | A sterile cover screw isenclosed with the implant sothat an immediate occlusion ofthe internal thread is possibleafter successful insertion. | A sterile cover screw isenclosed with the implant sothat an immediate occlusion ofthe internal thread is possibleafter successful insertion. | A sterile cover screw isenclosed with the implant sothat an immediate occlusion ofthe internal thread is possibleafter successful insertion. |
| Features | |||
| Length | 8, 10, 12 mm | 8, 10, 12, 14 mm | 8, 10, 12, 14 mm |
| Diameter | Ø3.75 mm, Ø4.1 mm | Ø3.3 mm, Ø4.1 mm, Ø 4.8 mm | Ø3.3 mm, Ø4.1 mm, Ø 4.8 mm |
| Material (ImplantandCoverScrew) | Pure titanium Grade 4conforming to ASTM StandardSpecification F67 | Pure titanium Grade 4conforming to ASTM StandardSpecification F67 | Pure titanium Grade 4conforming to ASTM StandardSpecification F67 |
| SurfaceTreatment | The surface is micro-structuredin the endosteal section and the | The surface is micro-structuredin the endosteal section and the | The surface is micro-structuredin the endosteal section and the |
| Manufacturer | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH |
| Implant-to-abutmentconnection | implant shoulder is polished.The implant surface has beenblasted with high-gradecorundum and afterwards acid-etched.Inner cone with octagonal anti-rotation device | implant shoulder is polished.The implant surface has beenblasted with high-gradecorundum and afterwards acid-etched.Inner cone with octagonal anti-rotation device | implant shoulder is polished.The implant surface has beenblasted with high-gradecorundum and afterwards acid-etched.Inner cone with octagonal anti-rotation device |
| Packaging | Implants are sold in plastictubes, fastened on a titaniumsupport with apre-assebledinsertion system.The tube with the implant isdouble-wrapped in blisterpackaging. | Implants are sold in plastictubes, fastened on a titaniumsupport with apre-assebledinsertion system.The tube with the implant isdouble-wrapped in blisterpackaging. | Implants are sold in plastictubes, fastened on a titaniumsupport with apre-assebledinsertion system.The tube with the implant isdouble-wrapped in blisterpackaging. |
| Sterilization | Gamma Irradiation, min. 25 kGy.The validation fulfills therequirements of ISO 11137-1and 11137-2. | Gamma Irradiation, min. 25 kGy.The validation fulfills therequirements of ISO 11137-1and 11137-2. | Gamma Irradiation, min. 25 kGy.The validation fulfills therequirements of ISO 11137-1and 11137-2. |
| Shelf Life | 5 years | 5 years | 5 years |
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The Dental Implants OKTAGON® Tissue and Bone Level are an addition to the currently distributed Dental Implant OKTAGON and to the Dental Implant System OKTAGON Bone Level.
The subject devices differ in that of an additional diameter of Ø3.75 mm and a conical design.
As the subject devices are comparable to the predicate devices in the intended use, material composition, surface treatment, the implant-to-abutment connection, the principal root-form design and the performance characteristics (e.g. strength and function) no new aspects regarding the substantial equivalence arise.
9. Conclusion
Based on these observations, we conclude that the Dental OKTAGON® Tissue Level and Bone Level implants are substantially equivalent to the identified predicate devices.
§ 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.