(361 days)
BioHorizons Laser-Lok Abutments for Nobel Biocare™ are intended for use with dental implants as a support for single or multiple unit prostheses in the maxilla or mandible of partially or fully edentulous patients. The abutments are compatible for use with Nobel Biocare™ NobelReplace™ Straight Groovy™, NobelReplace™ Tapered Groovy™, NobelSpeedy™ Replace™, Replace™ Select Tapered and Replace™ Select Straight implants with 3.5mm (NP), 4.3mm (RP) and 5.0mm (WP) platform diameter internal trichannel connections. The abutment screw is intended to secure the abutment to the endosseous implant.
BioHorizons Laser-Lok Titanium Base Abutments for Nobel are intended to be used as straight abutments.
BioHorizons Laser-Lok Abutments for Nobel Biocare™ are a series of machined titanium endosseous dental implant healing abutments and final restorative abutments supplied in platform diameters of 3.5mm, 4.3mm and 5.0mm which are compatible with the internal trichannel connection of Nobel Biocare™ endosseous dental implants. The series includes Simple Solutions Abutments, Custom Titanium Abutments and Titanium Base Abutments. Abutment material is titanium alloy as specified in ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The devices are further processed by applying patterns of micro-machined grooves or channels, known as Laser-Lok, to a specified portion of the abutment margin. The product is packaged using materials known in the industry to be appropriate for medical device packaging. Devices labeled 'STERILE' are provided with a minimum sterility assurance level of 10°, validated in compliance with ANSI/AAMI/ISO 11137-1 Sterilization of healthcare products -- Radiation -- Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices.
This document is a 510(k) Premarket Notification for BioHorizons Laser-Lok Abutments for Nobel Biocare™. It focuses on establishing substantial equivalence to existing predicate devices, rather than defining specific acceptance criteria for a new type of performance claim or conducting a human-in-the-loop study.
Therefore, many of the requested sections about acceptance criteria, study types, sample sizes, and ground truth establishment, which are typical for studies evaluating diagnostic accuracy or AI performance, are not applicable in this context. This submission primarily relies on design and material equivalence, and existing scientific literature regarding its key feature (Laser-Lok technology).
However, I can extract information related to the device's characteristics and the study mentioned to support its substantial equivalence.
Description of Device and Study Context
The BioHorizons Laser-Lok Abutments for Nobel Biocare™ are machined titanium dental implant abutments designed to be compatible with Nobel Biocare™ endosseous dental implants. Their distinguishing feature is the "Laser-Lok" surface, which consists of micro-machined grooves applied to a specified portion of the abutment margin. This surface is claimed to promote a functional connective tissue attachment, inhibit epithelial cell downgrowth, and enable crestal bone attachment.
The submission aims to demonstrate "substantial equivalence" to predicate devices, meaning it is as safe and effective as legally marketed devices.
1. Table of acceptance criteria and the reported device performance
This section is Not Applicable in the traditional sense of performance metrics for a diagnostic or AI device. The acceptance criteria for this 510(k) submission are based on demonstrating substantial equivalence to predicate devices in terms of design, materials, intended use, and general safety/effectiveness.
Instead of specific performance metrics, the "acceptance criteria" are implied by the demonstration that:
- The device's design, materials (titanium alloy, Laser-Lok surface feature), and manufacturing processes are comparable to legally marketed predicate devices.
- The intended use is consistent with predicate devices.
- The compatibility with specified Nobel Biocare™ implants is verified.
- The Laser-Lok technology, as demonstrated by the canine study and previous research, shows beneficial biological responses comparable to or better than traditional machined surfaces.
| Area of Evaluation | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance/Information |
|---|---|---|
| Material | Titanium alloy as specified in ASTM F136 (Wrought Titanium-6Aluminum-4Vanadium ELI Alloy). | Device material is titanium alloy per ASTM F136. |
| Design/Compatibility | Compatibility with Nobel Biocare™ internal tri-channel connections (3.5mm, 4.3mm, 5.0mm platforms). Substantially equivalent design to predicate devices. | Compatibility testing performed on a representative subset of Nobel Biocare™ tri-channel implants to verify compatibility. Detailed table of compatible implants and corresponding abutment part numbers provided. Design is "substantially equivalent to all features of the predicate implant devices." |
| Sterilization | Devices labeled 'STERILE' must meet a minimum sterility assurance level of 10^-6, validated per ANSI/AAMI/ISO 11137-1. | Devices labeled 'STERILE' are provided with a minimum sterility assurance level of 10^-6, validated in compliance with ANSI/AAMI/ISO 11137-1. |
| Biological Response | Superior or equivalent peri-implant hard and soft tissue healing compared to traditional machined abutments, as supported by scientific evidence. (Specific quantitative criteria not given in this summary). | A prospective canine model study demonstrated "significant improvement in peri-implant hard and soft tissue healing on the Laser-Lok healing abutments as compared to traditional machined abutment surfaces." Nevins et al. concluded "intense fibroblastic activity... resulting in an interlacing complex of connective tissue fibers oriented perpendicular to the abutment surface that served as a physiologic barrier to apical JE migration." |
| Safety & Effectiveness | Overall safety and effectiveness profile comparable to predicate devices for the stated intended use. | The clinical and nonclinical data indicate the new devices are safe and effective for their intended use and perform "as well or better than the referenced predicate devices." |
2. Sample size used for the test set and the data provenance
- Test Set (Canine Study): The study consisted of four cohorts. "Each group received nine implants with abutments placed at the time of surgery."
- Sample Size: 4 groups * 9 implants/group = 36 implants total. The number of animals is not explicitly stated, but typically multiple implants would be placed in each animal.
- Data Provenance: Prospective animal study (canine model). No country of origin specified, but likely where BioHorizons Implant Systems, Inc. is based (USA).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is Not Applicable as the canine study involved biological outcomes (healing patterns, tissue attachment) assessed directly by researchers/histologists, not by experts interpreting diagnostic images for a ground truth panel. The study relies on direct measurement and observation of histological and biological responses in an animal model.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is Not Applicable. The canine study results would typically be based on objective measurements (e.g., histological analysis, bone-to-implant contact ratios, epithelial downgrowth measurements) rather than subjective adjudication of interpretations. The study summary does not detail the specific methods of outcome assessment or any adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is Not Applicable. This submission is for a dental implant abutment, not an AI-assisted diagnostic device. No human reader or AI comparative effectiveness study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is Not Applicable. This is a physical medical device, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For the canine study mentioned, the "ground truth" was established through direct histological and biological assessment of the peri-implant tissues in the animal model. This would involve microscopic examination and potentially quantitative measurements of tissue integration, bone and soft tissue healing patterns, and epithelial attachment/downgrowth. This falls under outcomes data / pathology derived from an animal model.
8. The sample size for the training set
- This is Not Applicable. This device is a physical product, not an AI/machine learning model, so there is no training set in that context. The "training" data for the Laser-Lok technology itself would encompass previous research and development that led to its design, including prior studies referenced (like Nevins et al.).
9. How the ground truth for the training set was established
- This is Not Applicable for the same reason as point 8. The underlying scientific principles of the Laser-Lok surface feature were established through prior research (e.g., the Nevins et al. study cited), which would have used similar direct biological and histological assessment methods.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)