(306 days)
No
The summary describes a mechanical dental implant system and its components. There is no mention of any software, algorithms, or data processing that would suggest the use of AI or ML. The performance studies focus on mechanical and biocompatibility testing.
No.
The device itself does not treat a disease or condition; it serves as a support for prosthetic reconstructions, which are then used to restore function.
No
The device description indicates that it is a system of dental implants and abutments used to support prosthetic devices. Its intended use is to provide structural support for prosthetic reconstructions, not to diagnose a condition.
No
The device description explicitly states the abutments are made of Titanium Grade 4 and Titanium Alloy, indicating a physical hardware component.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Description: The description clearly states that this device is a "Dental Implant System OKTAGON® Bone Level" and "angled abutments". These are physical components designed to be surgically implanted into the jawbone to support prosthetic teeth.
- Intended Use: The intended use is to "provide support for prosthetic reconstructions" and are used in "single tooth replacements and multiple tooth restorations." This is a structural and mechanical function within the body.
The device is a medical device, specifically a dental implant system, but it does not perform any diagnostic testing on biological samples outside of the body.
N/A
Intended Use / 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. The Abutments are intended to be compatible to OKTAGON® Bone Level implants with diameters 3.3mm, 4.1mm and with the lengths 8mm, 10mm, 12mm and 14mm.
The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
Product codes
NHA
Device Description
The Dental Implant System OKTAGON® Bone Level 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 angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.
The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.
The abutments are available in the following variations including the corresponding screws:
Article No.: 22025, Variation: NC, Description: Abutment, Angled, 18°, Ø3.5mm, L 6.0 mm, H1.5mm, cementable, incl. basic screw 22030, Material Abutment: Titanium Grade 4, Material Screw: Titanium Alloy (TiAl6V4), Connection to Implant: Octagonal, fixating by screw, Intended Use: For crowns and bridges
Article No.: 22026, Variation: NC, Description: Abutment, Angled, 18°, Ø3.5mm, L 6.0 mm, H3.0mm, cementable, 22030, Material Abutment: Titanium Grade 4, Material Screw: Titanium Alloy (TiAl6V4), Connection to Implant: Octagonal, fixating by screw, Intended Use: For crowns and bridges
Article No.: 22030, Variation: NC, Description: Basic screw for NC abutment, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: -, Intended Use: For use with abutments
Article No.: 22041, Variation: NC, Description: Alligator Abutment Angled, 15°, H3.0mm, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: Conical, fixating by screw, Intended Use: Overdenture Prosthetic
Article No.: 22042, Variation: NC, Description: Alligator Abutment Angled, 15°, H4.0mm, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: Conical, fixating by screw, Intended Use: Overdenture Prosthetic
Article No.: 22103, Variation: RC, Description: Abutment, Angled, 18°, Ø5.0mm, L 8.0 mm, H1.5mm, cementable, Material Abutment: Titanium Grade 4, Material Screw: Titanium Alloy (TiAl6V4), Connection to Implant: Octagonal, fixating by screw, Intended Use: For crowns and bridges
Article No.: 22105, Variation: RC, Description: Abutment, Angled, 18°, Ø5.0mm, L 8.0 mm, H3.0mm, cementable, incl. basic screw 22122, Material Abutment: Titanium Grade 4, Material Screw: Titanium Alloy (TiAl6V4), Connection to Implant: Octagonal, fixating by screw, Intended Use: For crowns and bridges
Article No.: 22122, Variation: RC, Description: Basic screw for RC abutment, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: -, Intended Use: For use with abutments
Article No.: 22129, Variation: RC, Description: Alligator Abutment Angled, 15°, H3.0mm, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: Conical, fixating by screw, Intended Use: Overdenture Prosthetic
Article No.: 22130, Variation: RC, Description: Alligator Abutment Angled, 15° H4.0mm, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: Conical, fixating by screw, Intended Use: Overdenture Prosthetic
Article No.: 22131, Variation: RC/NC, Description: Basic Screw for Alligator, Material Abutment: Titanium Alloy (TiAl6V4), Material Screw: -, Connection to Implant: -, Intended Use: Overdenture Prosthetic
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Performance tests (breakage and 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".
The biocompatibility was evaluated according to ISO 10993-1. The evaluation shows, that the subject device is comparable in intended use, design and materials to the legally market predicate devices. There are no known negative biological effects of dental implants made of Titanium Grade 4. Thus the requirements of ISO 10993-1 are fulfilled.
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
§ 872.3630 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
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 stylized graphic of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, abstract design. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 21, 2016
Hager & Meisinger GmbH Dr. Melanie May Regulatory Affairs Hansemannstrasse 10 Neuss. 41468 Germany
Re: K160132
Trade/Device Name: Endosseous Dental Implant Abutments OKTAGON® Bone Level Regulation Number: 21 CFR 872.3630 Regulation Name: Endosseous Dental Implant Abutment Regulatory Class: Class II Product Code: NHA Dated: October 20, 2016 Received: October 20, 2016
Dear Dr. 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
1
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,
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
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K160132
Device Name
Endosseous Dental Implant Abutments OKTAGON® Bone Level
Indications for Use (Describe)
Indications for Use (Describe)
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 with the lengths 8mm, 10mm, 12mm and 14mm.
The Dental Implant System OKTAGON® Bone Level is intended for delayed loading, or for immediate loading when good primary stability is achieved and with appropriate occlusal load.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
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- 223 Contact Person: Dr. Melanie May Product approval and product validation (Regulatory Affairs)
2. Date prepared
Date prepared:
November 17th, 2016
Endosseous Dental Implant Abutments
3. Name of the device
Trade Name:
| OKTAGON® Bone Level | |
|---|---|
| Common Name: | Endosseous dental implant abutments |
| Classification Name: | Endosseous dental implant abutment |
| Product Code: | NHA |
| Regulation No: | 872.3630 |
| Class: | II |
| Panel: | Dental |
4. Predicate Devices:
| Predicate
Device | 510(k)
No. | Manufacturer | Trade Name |
|------------------------|---------------|--------------|------------------------------------------------------------|
| Primary
Predicate | K143539 | Meisinger | Dental Endosseous Implant
System OKTAGON® Bone
Level |
| Reference
Predicate | K132214 | Meisinger | Dental Abutment
OKTAGON® |
5. Device Description:
4
510(k) Summary
The Dental Implant System OKTAGON® Bone Level 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 angled abutments and an addition to the currently available Dental Implants and Abutments OKTAGON® Bone Level.
The abutments are made of Titanium Grade 4, the alligator abutments and screws are made of Titanium Alloy (TiAl6V4); the connection to the implants is achieved by an internal octagon/nut construction and a metric thread.
The abutments are available in the following variations including the corresponding screws:
| Article
No. | Variation | Description | Material | | Connection to
Implant | Intended
Use |
|----------------|-----------|-----------------------------------------------------------------------------------------------|--------------------------------|--------------------------------|------------------------------------|---------------------------|
| | | | Abutment | Screw | | |
| 22025 | NC | Abutment, Angled, 18°,
Ø3.5mm, L 6.0 mm,
H1.5mm, cementable, incl.
basic screw 22030 | Titanium
Grade 4 | Titanium
Alloy
(TiAl6V4) | Octagonal,
fixating by
screw | For crowns
and bridges |
| 22026 | NC | Abutment, Angled, 18°,
Ø3.5mm, L 6.0 mm,
H3.0mm, cementable, 22030 | Titanium
Grade 4 | Titanium
Alloy
(TiAl6V4) | Octagonal,
fixating by
screw | For crowns
and bridges |
| 22030 | NC | Basic screw for NC abutment | Titanium
Alloy
(TiAl6V4) | - | | For use with
abutments |
| 22041 | NC | Alligator Abutment Angled,
15°, H3.0mm | Titanium
Alloy
(TiAl6V4) | - | Conical,
fixating by
screw | Overdenture
Prosthetic |
| 22042 | NC | Alligator Abutment Angled,
15°, H4.0mm | Titanium
Alloy
(TiAl6V4) | - | Conical,
fixating by
screw | Overdenture
Prosthetic |
| 22103 | RC | Abutment, Angled, 18°,
Ø5.0mm, L 8.0 mm,
H1.5mm, cementable, | Titanium
Grade 4 | Titanium
Alloy
(TiAl6V4) | Octagonal,
fixating by
screw | For crowns
and bridges |
| 22105 | RC | Abutment, Angled, 18°,
Ø5.0mm, L 8.0 mm,
H3.0mm, cementable, incl.
basic screw 22122 | Titanium
Grade 4 | Titanium
Alloy
(TiAl6V4) | Octagonal,
fixating by
screw | For crowns
and bridges |
5
510(k) Summary
| Article
No. | Variation | Description | Material | | Connection to
Implant | Intended
Use |
|----------------|-----------|-------------------------------------------|--------------------------------|-------|----------------------------------|---------------------------|
| | | | Abutment | Screw | | |
| 22122 | RC | Basic screw for RC abutment | Titanium
Alloy
(TiAl6V4) | - | - | For use with
abutments |
| 22129 | RC | Alligator Abutment Angled,
15°, H3.0mm | Titanium
Alloy
(TiAl6V4) | - | Conical,
fixating by
screw | Overdenture
Prosthetic |
| 22130 | RC | Alligator Abutment Angled,
15° H4.0mm | Titanium
Alloy
(TiAl6V4) | - | Conical,
fixating by
screw | Overdenture
Prosthetic |
| 22131 | RC/NC | Basic Screw for Alligator | Titanium
Alloy
(TiAl6V4) | - | - | Overdenture
Prosthetic |
6. 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. 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 Dental Implant System OKTAGON® Bone Level 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
The following standards have been followed for the development, production, performance and safety testing of Dental Implant Abutment OKTAGON® Bone Level:
- Fatigue Testing according to ISO 14801
- Evaluation of Biocompatibility according to ISO 10993-1, ISO 7405 .
- Cytotoxicity Testing according to ISO 10993-5 .
6
510(k) Summary
- . Sterilization validation according to ISO 17665-1, ISO 17665-2 and ANSI/ AAMI ST 79
- Material Specification according to ASTM F136, ASTM F67, ISO 5832-. 2, ISO 5832-3
- Risk Management according to ISO 14971 ●
In order to demonstrate substantial equivalence performance tests (breakage and 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".
The biocompatibility was evaluated according to ISO 10993-1. The evaluation shows, that the subject device is comparable in intended use, design and materials to the legally market predicate devices. There are no known negative biological effects of dental implants made of Titanium Grade 4. Thus the requirements of ISO 10993-1 are fulfilled.
7
510(k) Summary
8. Basis for substantial equivalence
The intended use for Dental Implant Abutment OKTAGON® Bone Level is identical to the named predicated devices.
| Manufacturer | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH |
|---|---|---|---|
| 510(k) Number | Subject device K160132 | Primary Predicate K143539 | Reference Predicate K132214 |
| 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. 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 Dental Implant System OKTAGON® 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® 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 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. | 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 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. | |||
| 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 versions including the | 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 versions including the | 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. |
8
510(k) Summary
| Manufacturer | Hager & Meisinger GmbH | Hager & Meisinger GmbH | Hager & Meisinger GmbH |
|---|---|---|---|
| 510(k) Number | Subject device K160132 | Primary Predicate K143539 | Reference Predicate K132214 |
| corresponding screws. | corresponding screws. | ||
| Diameter, Length (L), Height (H) | Variation NC: | Variation NC: | Abutments: |
| Angled abutments: | Abutments: | Ø2.5-4.8, L= 1.5 - 7.0 mm, | |
| Ø3.5, L= 6 mm, H = 1.5 mm and 3.0 mm | Ø3.5, L= 6 mm, H = 1.0 mm, 2.0, 3.0 and 3.5 mm | Alligator Abutments: | |
| Alligator abutments: | Alligator abutments: | H = 1.0, 1.5, 2.0, 3.0 and 4.0 mm | |
| H = 3.0 mm and 4.0 mm | H = 2.0, 3.0, 4.0 and 5.0 mm | ||
| Variation RC: | Variation RC: | ||
| Angled abutments: | Abutments: | ||
| Ø5.0 mm, L= 8.5 mm, H = 1.5 mm and 3.0 mm | Ø5.0 and 6.5, L= 8.5 mm, H = 1.0, 2.0 and 3.0 mm | ||
| Alligator abutments: | Alligator abutments: | ||
| H = 3.0 mm and 4.0 mm | H = 1.0, 2.0, 3.0, 4.0 and 5.0 mm | ||
| Angulation | 18° for Abutments, 15° for angled Alligator | 0° for Abutments, 15° for angled Alligator | Max. 20° |
| Material | Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws) | Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws), synthetic material (plastic copings made of POM) | Titanium Grade 4 (abutments), Titanium Alloy (alligator abutments and screws), synthetic material (plastic copings made of POM) |
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 Abutment OKTAGON® Bone Level is substantially equivalent to the legally marketed predicate devices described.