(90 days)
No
The summary describes a physical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a dental implant, which is surgically placed to provide support for prosthetic restorations, directly affecting the function and structure of the body to treat a condition (edentulism), thus classifying it as a therapeutic device.
No
Explanation: This device is a dental implant system used for supporting prosthetic restorations, which is a therapeutic rather than a diagnostic function.
No
The device description clearly states it is a physical dental implant made of Titanium Grade 4, which is a hardware component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the dental implants are surgically placed in the body to support prosthetic restorations. This is an in-vivo application, meaning it's used within a living organism.
- Device Description: The description details a physical implant made of titanium, designed for surgical insertion and integration with bone tissue.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or screening.
IVD devices are used outside the body to analyze biological samples. This device is used inside the body for structural support.
N/A
Intended Use / Indications for Use
Dental implants OKTAGON® 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® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
Product codes
DZE, NHA
Device Description
The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching. Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region. 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. OKTAGON® Implant System includes four variations of the prosthetic connection: Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP); Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC). The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter. The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
maxillary and/or mandibular arches
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
- Sterilization validation according to ISO 11137-1 and 11137-2 (referenced from K143539; . a revalidation report can be found in Section 14 Sterilization and Shelf Life of this submission).
- . Sterilization validation according to ISO 17665 and ST79 (referenced from K143539). Based on the design, it was determined that the proposed abutments do not represent a new sterilization validation challenge. Thus, no additional testing was required.
- Sterile barrier system validation according to ISO 11607 (referenced from K143539). The packaging of the subject device and the reference device K143539 is the same, thus no additional testing was required.
- Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (referenced from K143539). The subject device uses the same materials and manufacturing methods as the reference device K 143539. Furthermore, the intended use, the sterilization methods and the tissue contact are identical. Thus, no additional testing was required.
- Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments (referenced from K143539, K162073 and K170287). Based on the same design and comparative surface area analysis, it was determined that the proposed implants do not represent a new worst case. Thus, no additional testing was required.
No animal testing or human clinical trials have been conducted.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Hager & Meisinger GmbH Adam Tomczak Regulatory Affairs Hansemannstrasse 10 Neuss, 41468 GERMANY
Mav 10, 2018
Re: K180360
Trade/Device Name: OKTAGON® Implant System Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: Class II Product Code: DZE, NHA Dated: February 6, 2018 Received: February 9, 2018
Dear Adam Tomczak:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration | Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below. |
|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | |
| 510(k) Number (if known) | K180360 |
| Device Name | OKTAGON® Implant System |
| Indications for Use ( Describe ) | Dental implants OKTAGON® 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® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load. |
| Type of Use ( Select one or both, as applicable ) | |
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
| | CONTINUE ON A SEPARATE PAGE IF NEEDED. |
| | This section applies only to requirements of the Paperwork Reduction Act of 1995. |
| | DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. |
| | The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: |
| | Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov |
| | "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." |
| FORM FDA 3881 (7/17) | Page 1 of 1
PSC Publishing Services (301) 443-6740 EF |
3
1. Applicant
| Hager & Meisinger GmbH | |
|---|---|
| Hansemannstrasse 10 | |
| 41468 Neuss | |
| Germany | |
| Contact Person: | Dr. Adam Tomczak, Regulatory Affairs |
| Phone: | 0049 2131 2012 293 |
| Fax: | 0049 2131 2012 223 |
| Date prepared: | 9 May 2018 |
2. Device
| Trade Name: | OKTAGON® Implant System |
|---|---|
| Common Name: | Dental Implants, Dental Implant Abutments |
| Classification Name: | Endosseous Dental Implants |
| Product Code: | DZE (primary product code), NHA |
| Regulation No: | 872.3640 |
| Class: | II |
| Panel: | Dental |
3. Predicate Devices
| 510(k) No. | Manufacturer | Trade Name |
|---|---|---|
| Primary predicate device: | ||
| K170287 | Hager & Meisinger GmbH | Dental Implants OKTAGON® Bone Level Tapered Design |
| Reference devices: | ||
| K162073 | Hager & Meisinger GmbH | Dental Implants OKTAGON® Tissue Level and Bone Level |
| K143539 | Hager & Meisinger GmbH | Dental Implant System OKTAGON® Bone Level |
4. Device Description
Endosseous Dental Implants
The proposed implants represent a line extension of dental implants OKTAGON®, which have been previously cleared in the submissions K170287, K162073 and K143539. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid-etching.
4
Tissue Level Conical Implants have a conical shape, and the endosteal body of Bone Level Tapered Design Implants is cylindrical in the coronal region and conical in the apical region.
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. OKTAGON® Implant System includes four variations of the prosthetic connection:
- Tissue Level Implants: Regular Platform (RP) and Wide Platform (WP) ●
- . Bone Level Implants: Regular Connect (RC) and Narrow Connect (NC)
| Ref. No. | Description | Prosthetic
connection | Diameter [mm] | Length [mm] |
|----------|--------------------|--------------------------|---------------|-------------|
| 31147 | TL Conical Implant | RP | 4.1 | 8.0 |
| 31175 | TL Conical Implant | RP | 4.1 | 12.0 |
| 24005 | BLT Implant | RC | 4.8 | 8.0 |
| 24006 | BLT Implant | RC | 4.8 | 10.0 |
| 24007 | BLT Implant | RC | 4.8 | 12.0 |
This submission contains the following implants:
TL =Tissue Level, BLT = Bone Level Tapered Design
The proposed Tissue Level Conical Implants will increase the range of lengths available for this implant variation. The proposed Bone Level Tapered Design implants will be offered in the same range of lengths as the predicate devices, but with an increased diameter.
Endosseus Dental Implant Abutments
The proposed healing abutments increase the range of diameters available for Bone Level Narrow Connect implants. They are manufactured from Titanium Grade 4, and are intended to close the implant and shape the surrounding soft tissue during the healing phase. No occlusal loading is intended.
| Ref. No. | Description | Prosthetic
connection | Diameter [mm] | Gingiva height
[mm] |
|----------|------------------|--------------------------|---------------|------------------------|
| 22070 | Healing Abutment | NC | 5.5 | 2.0 |
| 22071 | Healing Abutment | NC | 5.5 | 3.5 |
| 22072 | Healing Abutment | NC | 5.5 | 5.0 |
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5. Indications for Use
Dental implants OKTAGON® 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® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
6. Performance testing
Non-clinical data submitted, referenced, or relied upon to demonstrate substantial equivalence include:
- Sterilization validation according to ISO 11137-1 and 11137-2 (referenced from K143539; . a revalidation report can be found in Section 14 Sterilization and Shelf Life of this submission).
- . Sterilization validation according to ISO 17665 and ST79 (referenced from K143539). Based on the design, it was determined that the proposed abutments do not represent a new sterilization validation challenge. Thus, no additional testing was required.
- Sterile barrier system validation according to ISO 11607 (referenced from K143539). The packaging of the subject device and the reference device K143539 is the same, thus no additional testing was required.
- Biocompatibility assessment according to ISO 10993-1 and cytotoxicity testing according to ISO 10993-5 (referenced from K143539). The subject device uses the same materials and manufacturing methods as the reference device K 143539. Furthermore, the intended use, the sterilization methods and the tissue contact are identical. Thus, no additional testing was required.
- Fatigue testing according to ISO 14801 and FDA Special Controls Guidance Document Rootform Endosseous Dental Implants and Endosseous Dental Implant Abutments (referenced from K143539, K162073 and K170287). Based on the same design and comparative surface area analysis, it was determined that the proposed implants do not represent a new worst case. Thus, no additional testing was required.
No animal testing or human clinical trials have been conducted.
7. Basis for substantial equivalence
A comparison of the indications for use and the technological characteristics between the subject device and the predicate devices is provided in the table below:
6
| 510(k) Number | K180360 | K143539 (Primary Predicate Device) | K162073 | K170287 (Primary Predicate Device) |
|---|---|---|---|---|
| Manufacturer | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH |
| Indications for Use | Dental implants OKTAGON® 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® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery 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 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. | 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® Bone Level Tapered Design 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® abutments and prosthetic parts. The implants are intended for delayed loading in a two-stage surgery or for immediate loading when good primary stability is achieved and with appropriate occlusal load. | |||
| Description | The proposed implants represent a line extension of Dental Implants OKTAGON®, which have been previously cleared in the submissions K143539, K162073 and K170287. The proposed implants have a root-form design and are made of Titanium Grade 4 conforming to ASTM F67-13. The surface is microstructured in the endosteal section by blasting with high-grade corundum and acid- | 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 | 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® | The endosteal implant body of the subject device has a conical shape in the coronal region and is cylindrical in the apical region. The apical cylindrical part of the implant is relevant for the given endosteal diameter of 4.1 mm. The implants are made of commercially pure Titanium Grade 4 conforming to ASTM- F67. The surface is micro-structured in the | ||
| 510(k) Number | K180360 | K143539 (Primary Predicate Device) | K162073 | K170287 (Primary Predicate Device) |
| conical shape, and the endosteal body of Bone | ||||
| Level Tapered Design Implants is conical in the | ||||
| coronal region and cylindrical in the apical | ||||
| region. The implant shoulder is polished. | ||||
| The prosthetic connection is achieved with the | ||||
| help of an inner cone with an additional | ||||
| octagonal anti-rotation device. A sterile cover | ||||
| screw is enclosed with the implant so that an | ||||
| immediate occlusion of the internal thread is | ||||
| possible after successful insertion. | ||||
| The proposed healing abutments increase the | ||||
| range of diameters available for Bone Level | ||||
| Narrow Connect Implants. They are | ||||
| manufactured from Titanium Grade 4, and are | ||||
| intended to seal the implant and shape the | ||||
| surrounding soft tissue during the healing | ||||
| phase. No occlusal loading is intended. | 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 | 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. | high-grade corundum and afterwards acid- | |||
| etched. The implant shoulder is polished. | ||||
| The prosthetic connection is achieved | ||||
| with the help of an inner cone with an | ||||
| additional octagonal anti-rotation device. A | ||||
| sterile cover screw is enclosed with the | ||||
| implant so that an immediate occlusion of | ||||
| the internal thread is possible after | ||||
| successful insertion. | ||||
| Material | Titanium Grade 4 | Implants: Titanium Grade 4 | ||
| Abutments: Titanium Grade 4, Ti6Al4V, POM | Titanium Grade 4 | Titanium Grade 4 | ||
| Endosseous | ||||
| Surface | Micro-structured (grit blasted and acid etched) | Micro-structured (grit blasted and acid etched) | ||
| Connection | Inner cone with octagonal anti-rotation device | Inner cone with octagonal anti-rotation device | ||
| Length | 8/ 10/ 12 mm | 8/ 10/ 12/ 14 mm | 8/ 10/ 12 mm | 8/ 10/ 12 mm |
| Endosseous | ||||
| Diameter | 4.1/ 4.8 mm | 3.3 /4.1/ 4.8 mm | 3.75 / 4.1 mm | 3.3 / 3.75/ 4.1 mm |
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8. Conclusion
The subject device and the predicate devices have identical intended use and technological characteristics, and are made of identical materials. Based on the assessment of applicable performance data, the subject device does not raise new performance or safety issues. Thus, we concluded that the subject device is substantially equivalent to the legally marketed predicate devices listed above.