(175 days)
No
The summary describes a physical dental implant system and its mechanical properties, with no mention of software, algorithms, or data processing that would indicate AI/ML.
No
The device is a dental implant system used for structural support of dental prostheses, not to treat a disease or condition.
No
Explanation: The device is a dental implant system intended for surgical placement to support tooth restorations, not to diagnose a condition.
No
The device description explicitly states it is an "integrated system of endosseous dental implants" and lists various physical components like implants, abutments, prosthetic parts, and surgical instruments. It also describes mechanical fatigue testing of the physical implants.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for surgical placement in the body to support dental restorations. This is a therapeutic and structural function, not a diagnostic one.
- Device Description: The description details the physical components of a dental implant system, including implants, abutments, and surgical instruments. These are all physical devices used in a surgical procedure.
- Lack of Diagnostic Function: There is no mention of the device being used to test samples from the body (like blood, urine, or tissue) to diagnose a condition or disease.
- Performance Studies: The performance studies focus on mechanical strength and surface area for bone integration, which are relevant to the physical function of an implant, not a diagnostic test.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This dental implant system does not fit that definition.
N/A
Intended Use / Indications for Use
Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.
Product codes
DZE
Device Description
The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm 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, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.
The submission includes:
- Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
- Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandibles or maxillae
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)
Dynamic fatigue testing was performed with the 3.0 mm diameter implant at room temperature, in air, at 15 Hz to a maximum of 5 x 10 cycles. The test configuration was in conformance with ISO 14801:2007. The fatigue testing result shows that the subject device Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm is identical to predicate device Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm (K123512). Therefore Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm has sufficient mechanical strength for the intended clinical application.
To compare the implant surface area and bone to implant contact area of the Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm to the predicate devices, the implants have been remodeled using a CT scanner and generating 3D solid data. The surface area of those 3D models has been calculated for the total implantable length and considering 3mm bone resorption. The Biodenta implant's surface area and bone to implant contact area is larger than the predicate device's surface area and bone to implant contact area. Therefore the surface area' and bone to implant contact area is considered to be sufficient.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
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Image /page/0/Picture/0 description: This image contains text related to a premarket notification or 510(k) submission for the Biodenta Dental Implant System. The system is described as a Bone Level Tapered D3.0 and L6.5, and the document is identified as a 5-510(k) Summary. The image also contains the reference number K133884 and the Biodenta logo.
JUN 1 3 2014
5
510(k) Summary
| Owner's name: | Biodenta Swiss AG |
|---|---|
| Address: | Tramstrasse 16 |
| 9442 Berneck | |
| Switzerland | |
| Phone: | +41 71 747 11 11 |
| Fax number: | +41 71 747 11 12 |
| Contact person: | Mr. David Eiler, Regulatory Manager |
| Date summary prepared: | May 14, 2014 |
| Trade / proprietary name: | Biodenta Dental Implant System - Bone Level Tapered |
| D3.0 and L6.5 mm | |
| Common name: | Endosseous dental implant |
| Device classification name: | implant, endosseous, root-form |
| Product code: | DZE |
| Regulation number: | 21 CFR 872.3640 |
| Legally marketed device to which equivalence is claimed (predicate device): | |
| 1. Company: | Biodenta Swiss AG |
| Device name: | Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 |
| mm | |
| 510(k) number: | K123512 |
| 2. Company: | Biodenta Swiss AG |
| Device name: | Biodenta Dental Implant System - Bone Level Tapered |
| 510(k) number: | K123415 |
| 3. Company: | MIS - Implant Technologies Ltd. |
Revision
Section 2.0
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1
Premarket Notification / 510(k) Submission
Biodenta Dental Implant System – Bone Level Tapered D3.0 and L6.5 m
5 - 510(k) Summary
Image /page/1/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a sans-serif font, with a small "m" superscripted above the "b". To the right of the word is a registered trademark symbol. Above the word is a stylized image of three curved shapes, possibly representing leaves or waves.
| .
Device name:
| " " " The first on the see and the " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " " | Seven Implants; Biocom Implants; Lance Implants |
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| LAND Red Library Hotel July 2, 2012 13:44 1. 5. 1. 12. 1. 1984 1. MINNERSON 1. 1. 3. 5. | |
| 510(k) number | K103089 |
Indications for Use:
Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.
Device Description:
The Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5 mm 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, prosthetic parts and related surgical instruments. The Bone Level Tapered D3.0 and L6.5 mm implants use the same platforms and abutment connections like the Bone Level D 3.0 to 6.0 (K123512). Therefore the abutments and prosthetic parts which are compatible to the Bone Level D 3.0 to 6.0 (K123512) are also compatible to the predicate device.
The submission includes:
- Diameter 3.0 mm Implants with Length of: 10, 12, and 14 mm; Platform B0
- Diameter 4.1, 4.8, and 6,0 mm Implants with Length of: 6.5 mm; Platform B2
Non-clinical Testing Data:
Dynamic fatigue testing was performed with the 3.0 mm diameter implant at room temperature, in air, at 15 Hz to a maximum of 5 x 10° cycles. The test configuration was in conformance with ISO 14801:2007. The fatigue testing result shows that the subject device Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm is identical to predicate device Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm (K123512). Therefore Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm has sufficient mechanical strength for the intended clinical application.
To compare the implant surface area and bone to implant contact area of the Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm to the predicate devices, the implants have been remodeled using a CT scanner and generating 3D solid data. The surface area of those 3D models has been calculated for the total implantable length and considering 3mm bone resorption. The Biodenta implant's surface area and bone to implant contact area is larger than the predicate device's surface area and bone to implant contact area. Therefore the surface area' and bone to implant contact area is considered to be sufficient.
Clinical Testing:
Non-clinical test data was used to support the decision of safety and effectiveness.
Equivalence to marketed device:
Biodenta Swiss AG demonstrated that, for the purposes of FDA's regulation of medical devices, the Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design.
2
| Summary Substantial Equivalence Comparison to predicate devices: | ||||||
|---|---|---|---|---|---|---|
| -- | -- | ------------------------------------------------------------------ | -- | -- | -- | -- |
| Subject Device | Predicate Devices | |||
|---|---|---|---|---|
| Company | Biodenta Swiss AG | Biodenta Swiss AG | Biodenta Swiss AG | MIS - Implant Technologies Ltd. |
| Device Name | Biodenta Dental Implant System - Bone Level | |||
| Tapered D 3.0 and L. 6.5 mm | Biodenta Dental Implant System - Bone Level D 3.0 to 6.0 mm | Biodenta Dental Implant System - Bone Level Tapered | Seven Implants; Biocom Implants; Lance Implants | |
| 510(k) Number | New device- K133884 | K123512 | K123415 | K103089 |
| Intended Use | ||||
| Intended use | Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading. | Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. | Biodenta bone level tapered dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. | MIS dental implants are 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. |
| When a one stage surgical procedure is applied, the implant may be immediately loaded when good primary stability is achieved and the occlusal load is appropriate. | ||||
| MIS short implants are to be used only with straight abutment | ||||
| Implant Type | Root-form endosseous dental implant | |||
| Bone Level Implant | Root-form endosseous dental implant | |||
| Bone Level Implant | Root-form endosseous dental implant | |||
| Bone Level Implant | Root-form endosseous dental implant | |||
| Bone Level Implant | ||||
| Implant Shape | Tapered Wall | Straight Wall | Tapered Wall | Tapered Wall |
| Implant to Abut. | ||||
| Connection | Internal Hexagon | Internal Hexagon | Internal Hexagon | Internal Hexagon |
| Implant Diameter | ||||
| (& Length) | D 3.0 mm (L 10 - 14 mm) | |||
| D 4.1 mm (L 6.5 mm) | ||||
| D 4.8 mm (L 6.5 mm) | ||||
| D 6.0 mm (L 6.5 mm) | D 3.0 mm (L. 10-14 mm) | |||
| D 4.1 mm (L 6.5 mm) | ||||
| D 4.8 mm (L 6.5 mm) | ||||
| D 6.0 mm (L 6.5 - 12 mm) | 3.5 mm (8 - 14 mm) | |||
| 4.1 mm (8 - 14 mm) | ||||
| 4.8 mm (8 - 14 mm) | ||||
| 6.0 mm (8 - 12 mm) | D 4.2 (L 6 mm) | |||
| D 5.0 (L 6 mm) | ||||
| D 6.0 (L 6 mm) | ||||
| Abutment System | Angled and Straight | Angled and Straight | Angled and Straight | Angled and Straight |
| Angle | 0°, 15° | 0°, 15° | 0°, 15° | 0°, 15°, 20°, 25° |
| Implant Material | Titanium Grade 4 | Titanium Grade 4 | Titanium Grade 4 | Ti alloy (Ti 6Al 4V) |
| Abutment Material | Ti alloy (Ti 6Al 4V) | Ti alloy (Ti 6Al 4V) | Ti alloy (Ti 6Al 4V) | Ti alloy (Ti 6Al 4V) |
| Surface Treatment | Spark Anodization | |||
| (same surface modification as K123512 and K123415) | Spark Anodization | Spark Anodization | Sand blasted and acid etched | |
| Sterilization | Delivered Sterile Gamma Irradiation | Delivered Sterile | ||
| Gamma Irradiation | Delivered Sterile | |||
| Gamma Irradiation | Delivered Sterile | |||
| Gamma Irradiation |
Revision
Section 5
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Premarket Notification / 510(k) Submission Promanto. Notinoution System - Bone Level Tapered D3.0 and L6.5 m 5 - 510(k) Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a stylized symbol to the right and text wrapping around the left side. The symbol is composed of three curved lines that appear to be interconnected, creating an abstract design. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June13, 2014
Biodenta Swiss AG Mr. David Eiler Regulatory Manager Tramstrasse 16 9442 Berneck Switzerland
Re: K133884
Trade/Device Name: Biodenta Dental Implant System - Bone Level Tapered D3.0 and L6.5mm Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: May 14, 2014 Received: May 19, 2014
Dear Mr. Eiler:
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 - Mr. Eiler
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 (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.
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/Safetw/ReportalProblem/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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Image /page/5/Picture/9 description: The image shows the text "Mary S Runner" in a bold, sans-serif font. Below the name is the text "S FLA", with the letters stylized to appear as if they are made of rope or string. The text is black and the background is white.
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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Image /page/6/Picture/0 description: The image shows text related to a premarket notification for the Biodenta Dental Implant System. The notification is a 510(k) submission for a bone-level tapered implant with dimensions D 3.0 and L 6.5 mm. The text also mentions that it is related to indications for use. The logo for Biodenta is on the right side of the image.
Indications for Use
510(k) Number (if known): K133884
.
Device Name: Biodenta Dental Implant System - Bone Level Tapered D 3.0 and L 6.5 mm
Indications for Use:
Biodenta dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or terminal or intermediate abutment support for fixed or removable bridgework and to retain overdentures. They are intended for delayed loading.
Prescription Use __ X (Part 21 CFR 801 Subpart D) `
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Sheena A. Greer 2014.06.13 12:57:08-04'00'
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