(356 days)
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No
The document describes a mechanical dental device (abutments and screws) and its performance testing, with no mention of AI or ML technologies.
No.
The device, a dental implant abutment, provides support for prosthetic reconstructions, which is a structural or supportive function rather than a therapeutic one (treating or curing a disease or medical condition).
No.
The device is a dental implant abutment, which is a prosthetic component designed to support dental restorations, not to diagnose a medical condition.
No
The device description explicitly states the device is made of physical materials (Titanium Grade 4, Titanium Alloy, or POM) and is a physical component (abutments and screws) intended for surgical implantation. It is not a software-only device.
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 device is for providing support for prosthetic reconstructions in the mouth. This is a surgical/dental application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details the materials and design of dental implant abutments and screws, which are physical components used in dental procedures.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on biological samples to gain information about a person's health status. This device is a physical implant component.
N/A
Intended Use / Indications for Use
Dental Implant Abutments 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 Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
Product codes (comma separated list FDA assigned to the subject device)
NHA
Device Description
The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version 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 and a metric thread.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
For Dental Implant Abutments OKTAGON® a performance test (fatigue test) has been conducted.
The performed test fulfills the requirements listed in ISO 14801 and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8. The following standards have been considered for Dental Implant Abutments OKTAGON® during development, production and market surveillance: ISO 14801, ISO 7405, ISO 10993-1, ISO 5832-2, ASTM F67, ISO 14971, ISO 5832-3, ASTM F136. AAMI ST79. ISO 17665-1.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)
0
JUL 07 2014
510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®
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:
06/11/2014
3. Name of the device
Trade Name: Common Name: Classification Name: Product Code: Regulation No: Class: Panel:
Dental Implant Abutment OKTAGON® Endosseous dental implant abutments Endosseous dental implant abutment NHA 872.3630 . ll Dental
4. Predicate Devices:
| 510(k No.) | Manufacturer | Trade Name |
|---|---|---|
| K091701 | Straumann | Dental Abutment (Modified Dental |
| Implant Abutment) | ||
| K073628 | Straumann | Abutment, Dental, Endosseous |
| implants (RN synOcta 1.5 mm Abutment |
5. Device Description:
The OKTAGON® Dental Implant System is an integrated system of endosseous dental implants which are designed to support prosthetic devices for partially of fully edentulous patients. The devices covered in this submission are abutments in different version including the corresponding screws.
Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional ·
1
510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®
Section #5 510(k) Summary
The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the ' connection to the implants is achieved by an internal octagon and a metric thread.
6. Indications for use:
Dental Implant Abutments 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 Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm."
7. Performance tests and used standards / Clinical data
For Dental Implant Abutments OKTAGON® a performance test (fatigue test) has been conducted.
The performed test fulfills the requirements listed in ISO 14801 and the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Rootform Endosseous Dental Implants and Endosseous Dental Abutments, Chapter 8. The following standards have been considered for Dental Implant Abutments OKTAGON® during development, production and market surveillance: ISO 14801, ISO 7405, ISO 10993-1, ISO 5832-2, ASTM F67, ISO 14971, ISO 5832-3, ASTM F136. AAMI ST79. ISO 17665-1.
| Manufacturer | Hager & Meisinger
GmbH | Straumann AG | Straumann AG |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K132214 | K091701 | K073628 |
| Indications for Use | 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
and bridges.
Abutments can be used in
single tooth replacements and | Abutments are placed into
dental implants to provide
support for prosthetic
restorations such as crowns
and bridges.
Abutments can be used in
single tooth replacements and |
8. Basis for substantial equivalence
Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional
2
510(k) Traditional Dental Endosseous Implant Abutment OKTAGON®
Section #5 510(k) Summary
| Manufacturer | Hager & Meisinger GmbH | Straumann AG | Straumann AG |
|---|---|---|---|
| 510(k) Number | K132214 | K091701 | K073628 |
| Abutments can be used in single tooth replacements and multiple tooth restorations. | multiple tooth restorations. | 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 submission are abutments in different version including the corresponding screws. | The Straumann 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 system consists of a variety of dental implants, abutments and surgical and prosthetic parts and instruments. The devices covered in this submission are abutments. | The Straumann 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 system consists of a variety of dental implants, abutments and surgical and prosthetic parts , and instruments. The device covered in this submission is an abutment. |
| The coronal portion of the abutment is seated in the implant with a screw. The abutment is used for screw-retained and cemented restorations. | |||
| Material | Titanium Grade 4, Titanium Alloy, synthetic material | Not detailed in submission, acc. to catalogue same material used | Not detailed in submission, acc. to catalogue same material used |
| Connection | octagonal anti-rotation device | octagonal anti-rotation device | octagonal anti-rotation device |
The intended use for Endosseous Dental Implant Abutment OKTAGON® 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 the information provided in the summary, we conclude Dental Implant Abutments OKTAGON® are substantially equivalent to the legally marketed predicate devices described.
(
Endosseous Dental Implant Abutment OKTAGON®, Hager & Meisinger GmbH 510(k) Traditional
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features a stylized eagle with three legs, representing health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 7, 2014
Hager & Meisinger GMbh Ms. Wiebke Stolten Management, Regulatory Affairs Hansemannstrasse 10 Neuss, D-41468 GERMANY
Re: K132214
Trade/Device Name: Dental Implant Abutment OKTAGON® Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous dental implants abutment Regulatory Class: II Product Code: NHA Dated: June 2, 2014 Received: June 3, 2014
Dear Ms. 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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Page 2 - Ms. Stolten
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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
MaryDner-S
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 Endosseous Implant Abutment OKTAGON®
Section #4 Indications for Use Statement
510(k) Number (if known): K132214
Device Name: Dental Implant Abutment OKTAGON®
Indications for use:
Dental Implant Abutments 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 Dental Implant Abutments OKTAGON® are intended to be compatible to OKTAGON® implants (Dental Implant OKTAGON®) with diameters 3.3mm, 4.1mm and 4.8mm in the variation Regular Platform, Wide Platform and Tapered Design with the lengths 8mm, 10mm, 12mm and 14mm.
Over-The-Counter Use AND/OR Prescription Use X (Part 21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(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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