(78 days)
No
The description focuses on the mechanical design and materials of the dental implant system, with no mention of AI or ML technologies for image processing, diagnosis, or any other function.
No
The device serves as an artificial root structure for tooth replacement and abutments for fixed bridgework and denture retention, which is a restorative and supportive function, not a therapeutic one aimed at treating a disease or disorder.
No
The device description and intended use indicate that the BioHorizons Dental Implant System is used as an artificial root structure or abutments, which are therapeutic and restorative functions, not diagnostic.
No
The device description explicitly states it is a "comprehensive system containing implants, surgical components, and prosthetic components," which are physical hardware.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Description: The BioHorizons Dental Implant System is a physical implant and associated components designed to be surgically placed inside the body to replace missing teeth.
- Intended Use: The intended use is to function as an artificial root structure and abutments within the mandible and maxilla.
The description clearly indicates a surgically implanted device, not a device used for testing biological samples in a lab setting.
N/A
Intended Use / Indications for Use
The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Product codes
Not Found
Device Description
The BioHorizons Dental Implant System is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, D4) in the mandible and maxilla. Four implant designs, corresponding to each bone density classification, are available in four and five mm diameters. Each implant design, manufactured from titanium alloy conforming to ASTM F 136, is available in two lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mandible and maxilla
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)
Evaluation of the BioHorizons Dental Implant System consisted mechanical testing of the implant and bioactive coating mechanical tests. These analyses indicate that the BioHorizons Dental Implant System should be safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K960026, Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants
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
JAN | 7 1997
BioHorizons Implant Systems, Inc. 510(k) Notification October 24, 1996
K964330
510(k) Summary of Safety and Effectiveness
Proprietary Name
BioHorizons Dental Implant System (name subject to change)
Common Name
Uncoated, titanium plasma spray, and hydroxyapatite screw-form implants, surgical components, and prosthetic components
Classification Name
Endosseous implants, surgical components, and prosthetic attachments
Classification
Class III
Official Contact
R. Steven Boggan, M.S., M.BA. President and Chief Operating Officer BioHorizons Implant Systems, Inc. 2129 Montgomery Highway Birmingham, AL 35209 (205) 871-1345 FAX (205) 870-0304
Device Description
.....
The BioHorizons Dental Implant System is a comprehensive system containing implants, surgical components, and prosthetic components. The implants are specifically designed to optimize strain distribution to contiguous bone under functional loading in order to promote strain-induced bone growth and interface maintenance over the long term. This improvement in biomechanical performance is achieved by optimizing implant designs specifically for each bone density classification (D1, D2, D3, D4) in the mandible and maxilla.
Four implant designs, corresponding to each bone density classification, are available in four and five mm diameters. Each implant design, manufactured from titanium alloy
1
BioHorizons Implant Systems, Inc. 510(k) Notification October 24, 1996
conforming to ASTM F 136, is available in two lengths and may feature a titanium plasma-spray (TPS) or hydroxyapatite (HA) coating. The following table provides a comprehensive summary of implant diameter, length, and coating.
| Diameter (mm) | Design | Lengths (mm) | Coating |
|---|---|---|---|
| $\phi4.00$ | D1 | 10, 12 | Uncoated |
| D2 | 11, 13 | Uncoated | |
| D3 | 12, 14 | TPS | |
| D4 | 13, 15 | HA | |
| $\phi5.00$ | D1 | 9, 11 | Uncoated |
| D2 | 10, 12 | Uncoated | |
| D3 | 11, 13 | TPS | |
| D4 | 12, 14 | HA |
Product Evaluation
Evaluation of the BioHorizons Dental Implant System consisted mechanical testing of the implant and bioactive coating mechanical tests. These analyses indicate that the BioHorizons Dental Implant System should be safe and effective when used as intended.
Indications
The BioHorizons Dental Implant System may be used in the mandible and maxilla for use as an artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention.
Substantial Equivalence Information
The BioHorizons Dental Implant System is substantially equivalent in all features which could affect safety or effectiveness to the BioHorizons Dental Implant System (K960026) and the Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants.