(161 days)
BioHorizons Laser-Lok 3.0 Implants may be used as an artificial root structure for single tooth replacement of mandibular central and lateral incisors and maxillary lateral incisors.
The implants may be restored immediately
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- with a temporary prosthesis that is not in functional occlusion,
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- when splinted together as an artificial root structure for multiple tooth replacement of mandibular incisors, or
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- for denture stabilization using multiple implants in the anterior mandible and maxilla.
The implants may be placed in immediate function when good primary stability has been achieved and with appropriate occlusal loading.
BioHorizons Laser-Lok 3.0 Implants are machined titanium, screw-form endosseous dental implants supplied in 3.0mm diameter across lengths of 10.5mm. 12mm and Implant material is titanium alloy as specified in ASTM F136 Standard 15mm. Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy (UNS R56401) for Surgical Implant Applications.
The devices are further processed by roughening the threaded surface with Resorbable Blast Texture (RBT) media (tricalcium phosphate) and by application of patterns of micro-machined grooves or channels, known as Laser-Lok®, to the implant collar. The product is packaged using materials known in the industry to be appropriate for medical device packaging and is provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/SO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
The BioHorizons Laser-Lok 3.0 Implant System includes a series of implant abutments, as well as the usual and customary restorative components.
The acceptance criteria for the BioHorizons Laser-Lok 3.0 Implant System and the study supporting its performance are detailed below.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Strength | Demonstrated substantial equivalence in performance, safety, and effectiveness to predicate devices. |
| Predefined Acceptance Criteria | The device "meets its predefined acceptance criteria." |
| Intended Use | The device "performs in accordance with its intended use." |
2. Sample Size and Data Provenance
The 510(k) summary only mentions "fatigue testing" without specifying the exact sample size for the test set (number of implants tested). The data provenance is not explicitly stated regarding country of origin or whether it was retrospective or prospective. It is implied to be internal testing conducted by the manufacturer, BioHorizons Implant Systems, Inc.
3. Number of Experts and Qualifications for Ground Truth
No information is provided regarding experts used to establish ground truth for a test set, as the study described is a physical performance (fatigue) test, not a clinical or image-based study requiring expert interpretation.
4. Adjudication Method
Not applicable. The study involved physical fatigue testing, not a clinical or image-based assessment requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The submission focuses on physical performance testing (fatigue testing) of the implant system itself, not on human reader performance with or without AI assistance.
6. Standalone Performance Study
Yes, a standalone study was performed. The "fatigue testing" described is a standalone evaluation of the device's physical performance characteristics. It assesses the device's ability to withstand repeated loads without human intervention or interpretation.
7. Type of Ground Truth Used
The ground truth used was based on engineering standards and predefined acceptance criteria related to the fatigue performance of dental implants. This would typically involve objective measurements of fracture strength, resistance to cyclic loading, and comparison to established industry standards for similar devices. The comparison against predicate devices also serves as a form of "ground truth" for substantial equivalence.
8. Sample Size for the Training Set
No training set is mentioned as the study described is a physical performance test. This type of study does not involve training an algorithm or model.
9. How Ground Truth for Training Set Was Established
Not applicable, as no training set was used.
§ 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.