(157 days)
Not Found
No
The summary describes a mechanical dental implant system and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device, Biodenta bone level dental implants, is intended for surgical placement to support dental restorations, not to treat or cure a disease or condition. Its purpose is to replace missing teeth, which is a restorative function.
No
The device description indicates that the Biodenta Dental Implant System is designed to support prosthetic devices for partially or fully edentulous patients, which is a treatment function, not a diagnostic one. There is no mention of it being used to identify or characterize diseases or conditions.
No
The device description explicitly states the system consists of "a variety of dental implants, abutments and prosthetic parts and related surgical instruments," which are physical hardware components.
Based on the provided information, 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 (mandibles or maxillae) to support dental restorations. This is a surgical and prosthetic application, not a diagnostic test performed on samples outside the body.
- Device Description: The description details implants, abutments, prosthetic parts, and surgical instruments. These are all components used in a surgical procedure and subsequent prosthetic support, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples (blood, urine, tissue, etc.) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are designed to be used in vitro (outside the body) to examine specimens from the human body. This device is clearly intended for in vivo (within the body) use.
N/A
Intended Use / Indications for Use
Biodenta bone level 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.
Product codes
DZE
Device Description
The Biodenta Dental Implant System - Bone Level 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 prosthetic parts and related surgical instruments.
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)
Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff and ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The worst case scenario for the Biodenta Dental Implant System - Bone Level implants and abutments was tested. These results show that Biodenta Dental Implant System - Bone Level have sufficient mechanical strength for their intended clinical application.
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.
0
Image /page/0/Picture/1 description: The image shows the word "biodenta" in bold black font with a registered trademark symbol next to it. Above the word is a curved graphic. Below the word is the text "JC111003" in a handwritten style.
SEP 1 5 2011
510(k) Summary
Biodenta Swiss AG Owner's name: Tramstrasse 16 9442 Berneck Address: Switzerland Phone: +41 71 747 11 11 + 41 71 747 11 12 Fax number: Contact person: Mr. David Eiler, Regulatory Manager Date summary prepared: April 8, 2011 Trade / proprietary name: Biodenta Dental Implant System - Bone Level Endosseous dental implant Common name: Device classification name: implant, endosseous, root-form Product code: DZE Regulation number : 21 CFR 872.3640 NHA (Regulation number: 21 CFR 872.3630) Subsequent Product Code: Legally marketed device to which equivalence is claimed (predicate device): Company: Biodenta Swiss AG Biodenta Dental Implant System Device name: K093630 510(k) number: Nobel Biocare Ab Company: Device name: Nobelactive Internal Connection Implant K071370 510(k) number:
1
Image /page/1/Picture/1 description: The image shows the word "biodenta" in bold, black font, with a registered trademark symbol to the right of the word. Above the word is a curved, abstract design. Below the word "biodenta" is the handwritten number "K111003".
Indications for Use:
Biodenta bone level dental implants are intended for surgical placement in mandibles or maxillae to support single or multiple tooth restorations or intermediate abutment support for fixed or removable bridgework and to retain overdentures.
Device Description:
The Biodenta Dental Implant System - Bone Level 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 prosthetic parts and related surgical instruments.
Non-clinical Testing Data:
Fatigue testing was conducted according to FDA Guide: Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments -Guidance for Industry and FDA Staff and ISO 14801 Dentistry-Implants-Dynamic fatigue test for endosseous dental implants. The worst case scenario for the Biodenta Dental Implant System - Bone Level implants and abutments was tested. These results show that Biodenta Dental Implant System - Bone Level have sufficient mechanical strength for their intended clinical application.
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 is substantially equivalent to the predicate devices in intended use, material composition, fundamental scientific technology, principles of operation, and basic design. When compared with the predicate devices, no new questions of safety or effectiveness have been raised for the Biodenta Dental Implant System - Bone Level.
2
Image /page/2/Picture/1 description: The image shows the word "biodenta" in bold, black font, with a registered trademark symbol to the right of the word. Above the word is a logo that appears to be three curved lines stacked on top of each other. Below the word "biodenta" is the text "K111003" in a handwritten-style font.
Substantial Equivalence Comparison to predicate device:
| Subject Device | Predicate Devices | ||
|---|---|---|---|
| Device | Biodenta Dental Implant | ||
| System - Bone Level | Biodenta Dental Implant | ||
| System (K093630) | Nobelactive Internal Connection | ||
| Implant (K071370) | |||
| Intended use | Biodenta bone level 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 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. | |||
| Specific indications for small | |||
| diameter (Ø 3.5 mm) | |||
| implants: It is recommended | |||
| not to place small implants | |||
| with "NP" platform in the | |||
| molar or premolar region. | Nobel Biocare's NobelActive | ||
| implants are endosseous implant | |||
| intended to be surgically placed in | |||
| the bone of the upper or lower jaw | |||
| arches to provide support for | |||
| prosthetic devices, such as an | |||
| artificial tooth, in order to restore | |||
| patient esthetics and chewing | |||
| function. Nobel Biocare's | |||
| NobelActive implants are indicated | |||
| for single or multiple unit | |||
| restorations in splinted or non- | |||
| splinted applications. Nobel | |||
| Biocare's NobelActive implants may | |||
| be placed immediately and put into | |||
| immediate function provided that | |||
| initial stability requirements detailed | |||
| in the manual are satisfied. | |||
| System | threaded, root-form dental | ||
| implant, bone level | threaded, root-form dental | ||
| implant, tissue level | threaded, root-form dental | ||
| implant, bone level | |||
| Diameter | 3.5 mm, 4.1 mm, 4.8 mm | 3.5 mm, 4.1 mm, 4.8 mm | 3.5 mm, 4.3 mm, 5.0 mm |
| Connection | Internal Hexagon | Internal Octagon | Internal Hexagon |
| Implant | |||
| Material | Titanium | Titanium | Titanium |
| Abutment | |||
| System | Angled Abutment | Angled Abutment | Angled Abutment |
| Abutment | |||
| Angle | 0°, 15° | 0°, 15°, 20° | 0°, 15° |
| Abutmet | |||
| Material | Titanium Alloy | Titanium Alloy | Titanium Alloy |
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three lines forming its body and wings. The eagle is facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MID 20993-0002
Mr. David Eiler Regulatorv Manager Biodenta Swiss AG Tramstrasse 16 9442 Berneck Switzerland
SEP 15 2011
Re: K111003
Trade/Device Name: Biodenta Dental Implant System - Bone Level Regulation Number: 21 CFR 872.3640 Regulation Name: Endosseous Dental Implant Regulatory Class: II Product Code: DZE Dated: September 9, 2011 Received: September 12, 2011
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 vou, 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 Eederal Register.
4
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/McdicalDevices/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 vours,
Nh for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Image /page/5/Picture/1 description: The image shows the logo for "biodenta". The logo consists of the word "biodenta" in a bold, sans-serif font, with a registered trademark symbol to the right of the word. Above the word is a stylized graphic that appears to be a curved shape with lines inside.
Indications for Use
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: Biodenta Dental Implant System - Bone Level
Indications for Use:
Biodenta bone level 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.
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)
Susan Rumm
(Division Sign-Ott) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K111003
Page 1 of 1
Revision 1.1 Section な 2 01 4 Section page