(86 days)
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No
The summary describes a traditional dental implant system with different designs optimized for bone density classifications, evaluated through engineering analyses and mechanical tests. There is no mention of AI or ML.
Yes
The device is described as an "artificial root structure" and is used for "single tooth replacement or as abutments for fixed bridgework and denture retention," which directly addresses and corrects a medical condition (missing teeth).
No
Explanation: The device is a dental implant system used as an artificial root structure, not for diagnosing medical conditions.
No
The device description explicitly states that the system contains implants, surgical components, and prosthetic components, which are physical hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is an "artificial root structure for single tooth replacement or as abutments for fixed bridgework and denture retention." This describes a surgical implant used in vivo (within the body) for structural support.
- Device Description: The description details the physical components of the system (implants, surgical components, prosthetic components) and their material (titanium alloy). It focuses on biomechanical performance and design for different bone densities.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples, to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body to provide information about a person's health status. This device is a physical implant placed within the body.
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
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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 glass bead, titanium plasma-spray (TPS), or hydroxyapatite (HA) coating. The body of each implant includes a significant enhancement of the basic screw-form. The objective is to optimize the implant macrodesign to optimize the implant-bone interface within specific regions of the mandible and maxillary bone. This objective is accomplished by varying thread depth and thread form within and between each implant design. Pitch is varied between the four implant designs.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
mandible and maxilla
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Evaluation of the BioHorizons Dental Implant System consisted of (1) closed form Evaluations, (2) finite element analyses, (3) implant mechanical tests, and (4) bioactive coating mechanical tests. These analyses indicate that the BioHorizons Dental Implant System is safe and effective when used as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
MAR 2 8
BioHorizons Implant Systems. Inc. 510(k) Notification December 30, 1995
KSCCDXC
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. Vice President Of Research and Development 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
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1
BioHorizons Implant Systems, Inc. 510(k) Notification December 30, 1995
conforming to ASTM F 136, is available in two lengths and may feature a glass bead, a
re and the many and contract and servenatite (HA) coating. The following table conforming to ASTM F 136, is available in two lengths and may been and may be and the may be the may be the may be the titanium plasma-spray (TPS), or hydroxyapatite (117) only 16 mg
provides a comprehensive summary of implant diameter, length, and coating.
| Diameter (mm) | Design | Lengths (mm) | Coating |
|---|---|---|---|
| $\4.00 | D1 | 10, 12 | Glass Bead |
| D2 | 11, 13 | TPS | |
| D3 | 12, 14 | HA | |
| D4 | 13, 15 | HA | |
| $\5.00 | D1 | 9, 11 | Glass Bead |
| D2 | 10, 12 | TPS | |
| D3 | 11, 13 | HA | |
| D4 | 12, 14 | HA |
The body of each implant includes a significant enhancement of the basic screw-form.
The mandible and started and submiss and specific regions of the mandible and The body of each implant includes a significant ennationing of the mandble and of
implant macrodesign to optimize the impliched by varving thread depth and thread implant macrodesign to optimize the implains the one of the thread depth and thread.
maxillary bone. This objective is accomplished by varied herween the four implant maxillary bone. This objective is accomplished by varying and .
form within and between each implant design. Pitch is varied between the four implant . designs.
Product Evaluation
Evaluation of the BioHorizons Dental Implant System consisted of (1) closed form Evaluations, (2) finite element analyses, (3) implant mechanical tests, and (4) bioactive
calculations, (2) finite element analyses, (3) implant mechanical tests, and (4) inc calculations, (2) finite element analyses (1) inplain intelle BioHorizons Dental Implant
coating mechanical tests. These analyses indicate that the BioHorizons Dental Implan coating mechanical tests. " Press and effective when used as intended.
Indications
The BioHorizons Dental Implant System may be used in the mandible and maxilla for use The BioHorizons Dental Implant System may oo assess in .
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 The BioHorizons Dental Implant System is substantially open.
could affect safety or effectiveness to the Steri-Oss® Hex-Lock (HL) Threaded Titanium Implants and the Branemark System® Implants