(259 days)
Not Found
No
The document describes a standard dental implant system and its components. There is no mention of AI or ML in the intended use, device description, or performance studies.
No.
The device, which comprises dental implants and abutments, is used to provide support for prosthetic restorations. It does not actively treat or cure a disease, but rather provides a structural replacement.
No
This device describes dental implants and abutments, which are surgically implanted to support prosthetic restorations. Their purpose is therapeutic (providing support for prosthetics), not diagnostic (identifying or characterizing a disease or condition).
No
The device description clearly details physical components made of titanium and POM, which are surgically implanted or attached to implants. This indicates a hardware-based medical device, not a software-only one.
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 implants are surgically placed in the maxillary and/or mandibular arches to provide support for prosthetic restorations. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device description details the materials and design of dental implants and abutments, which are physical devices implanted into the bone.
- 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 screening.
IVD devices are used outside the body to analyze samples. This device is used inside the body as a structural support.
N/A
Intended Use / 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.
Product codes
DZE, NHA
Device Description
The Bone Level Implant is an addition to the currently distributed OKTAGON® dental implant system.
The root-form designed implant is made of commercially pure Titanium Grade 4 conforming to ASTM Standard Specification F67. The surface is micro-structured in the endosteal section and the implant shoulder is polished. The implant surface has been blasted with high-grade corundum and afterwards acid-etched.
The prosthetic connection is achieved with the help of an inner cone with an additional octagonal anti-rotation device.
A sterile locking screw is enclosed with the implant so that an immediate occlusion of the internal thread is allowed after successful insertion.
The endosseous dental implants are available in a range of endosseous diameters and lengths.
The abutments are available in different versions including the corresponding screws. The abutments are made of Titanium Grade 4, Titanium Alloy or POM; the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.
The following types of abutments will be available:
- . Cover screw
- Healing abutment
- Straight abutment ●
- Alligator abutment
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
Prescription Use
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)
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 Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments".
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K122807, K062129, K132214, K072071, K080286
Reference Device(s)
Not Found
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/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 | ||
| 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® Bone Level abutments | |||
| and prosthetic parts. |
The Dental Implant OKTAGON®
system Bone Level 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® abutments and prosthetic
parts. | The P.004 is intended for
immediate, delayed, or
conventional placement in
the anterior maxillary an/or
mandibular arches to
support crowns, bridges or
overdentures in edentulous
or partially edentulous
patients. |
| Description | The root-form designed implant is
made of commercially pure Titanium
Grade 4 conforming to ASTM Standard
Specification F67. The surface is micro-
structured in the endosteal section and
the implant shoulder is polished. The
implant surface has been blasted with
high-grade corundum and afterwards
acid-etched.
The prosthetic connection is achieved
with the help of an inner cone with an
additional octagonal anti-rotation
device. | The Dental Endosseous Implant
OKTAGON® is a root-form design
made of commercially pure Titanium
Grade 4 conforming to ASTM
Standard Specification F67. The
surface is micro-structured in the
endosteal section and the implant
shoulder is polished. The implant
surface has been blasted with high-
grade corundum and afterwards acid-
etched.
The prosthetic connection is achieved
with the help of an inner cone with an | The P.004 is an addition to
the currently distributed
Straumann Dental Implant
System. The P.004 implant
is a solid screw with a SLA
(grit blasted then acid
etched) or SLA surface. The
implants are composed of
Grade 4 commercially pure
Titanium and are available in
a range of lengths and
diameters. |
Overview Implants:
6
Section #5 510(k) Summary
| | 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. | 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. | |
|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|
| Material | Titanium Grade 4 | Titanium Grade 4 | Titanium Grade 4 |
| Surface
endosseous | Micro-structured (grit blasted and acid
etched) | Micro-structured (grit blasted and acid
etched) | grit blasted then acid etched |
| Length | 8mm to 14mm endosseous length | 8mm to 14mm endosseous length | 8mm to 14mm endosseous
length |
| Diameter | 3.3 to 4.8 mm endosseous | 3.3 to 4.8 mm endosseous, Ø 6.5
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. |
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 | ||||
| different version including | ||||
| the corresponding screws. | covered in this submission | |||
| are abutments. | system consists of a | |||
| variety of dental | ||||
| implants, abutments and | ||||
| surgical and prosthetic | ||||
| parts and instruments. | system consists of a | |||
| variety of dental | ||||
| implants, abutments and | ||||
| surgical and prosthetic | ||||
| parts and instruments. | ||||
| Material | Titanium Grade 4, Titanium | |||
| Alloy, synthetic 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 |
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.