(132 days)
The BioHorizons Multi-unit Abutments for CONELOG® are intended to function in the mandble or maxilla to support single and multiple-unit temporary or definitive restorations on CONELOG dental implants.
The purpose of this submission is to obtain marketing clearance for BioHorizons Multi-unit Abutments for CONELOG® implants. The submission includes a set of multi-unit abutment screws compatible with two (2) implant lines within the CONELOG® Implant System, manufactured by Altatec GmbH. This compatibility was established via a business agreement between BioHorizons Implant Systems, Inc. and Altatec GmbH. The corresponding compatible CONELOG implant platform diameters range from 3.3 mm to 4.3 mm. All sizes of the compatible CONELOG dental implants have the same tapered implant/abutment interface connection design as the subject device. The connection includes three (3) positioning cams on the abutment that engage complementary features on the implant to prevent rotation of the abutment relative to the implant.
The subject device Multi-unit Abutments for CONELOG are designed for attachment of single-unit and multi-unit screw-retained restorations. They are available in straight and angled designs, which are referred to as Multi-unit Straight Abutment for CONELOG and Multi-unit Angled Abutment for CONELOG, respectively. The straight and angled designs each are available in gingival heights of 2, 3, and 4 mm. All designs have a prosthetic diameter of 4.8 mm.
Multi-unit Angled Abutment for CONELOG designs have the coronal end inclined at either 17° or 30° to the implant axis for correction of angulation. The angled abutment includes an internal thread in the coronal portion of the abutment to accommodate a prosthetic screw for the screw-retained restoration. Each angled abutment is available in Type A or Type B orientations. Type A refers to an orientation in which one (1) of the three (3) positioning cams is aligned opposite the direction of abutment angulation. Type B refers to an orientation in which the cam alignment coincides with the direction of abutment angulation.
The subject device Multi-unit Abutments for CONELOG includes Class II abutment-level prosthetic components used for fabrication of provisional and final restorations. These prosthetic components include copings made of titanium alloy, gold alloy, or polyoxymethylene, a temporary cover cap made of titanium alloy, and prosthetic screws made of titanium alloy. The titanium alloy and gold copings and the prosthetic screws become part of the finished restoration.
All subject device abutments and abutment screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).
The provided text describes the regulatory clearance of a dental device and discusses its substantial equivalence to predicate devices, but it does not contain information about formal acceptance criteria or a study proving that the device meets specific performance criteria in a clinical or user-focused sense. The "performance data" section explicitly states "No clinical data were included in this submission."
The document details non-clinical data submitted for regulatory approval, which focuses on demonstrating safety and equivalence, not necessarily specific performance against clinical acceptance criteria.
Therefore, for most of your requested information, the answer based solely on the provided text is that the data is not present.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Not explicitly stated as such, but inferred from non-clinical tests for regulatory clearance) | Reported Device Performance (from "PERFORMANCE DATA" section) |
|---|---|
| Sterilization according to ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2. | "sterilization according to ANSVAAMI/ISO 11137-1 and ANSI/AAMI/ISO 11137-2, referenced from K172576, and K103691" (Implied compliance by reference to cleared predicates). |
| Biocompatibility according to ISO 10993-5 and ISO 10993-12. | "biocompatibility according to ISO 10993-5 and ISO 10993-12, referenced from K103691, K172576 and K193401" (Implied compliance by reference to cleared predicates). |
| Static compression and compression fatigue testing according to ISO 14801. | "Mechanical performance testing of the subject device was performed according to ISO 14801 Dentistry - Implants -Dynamic fatigue test for endosseous dental implants. The fatigue limit data demonstrated that constructs of the subject device abutments in combination with the previously-cleared compatible implants, and used according to the proposed labeling, have sufficient strength for their intended use." |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for any of the non-clinical tests. For mechanical testing (ISO 14801), while testing is mentioned, the number of samples tested is not provided in detail.
- Data Provenance: Not specified. The studies are non-clinical (laboratory testing) rather than clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. The described "performance data" refers to non-clinical (laboratory) testing, not studies requiring expert ground truth for clinical outcomes or diagnoses.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. This pertains to clinical studies often involving human interpretation and consensus, which is not described here.
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
- No. The document explicitly states: "No clinical data were included in this submission." This type of study is specifically clinical and often involves AI, which is not mentioned in the context of this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This device is a dental abutment, a physical medical device, not an algorithm or AI system.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- Not Applicable. The performance data discussed is for non-clinical, mechanical, and material testing. The "ground truth" for these types of tests would be the established scientific and engineering principles and the results from the standardized testing protocols themselves.
8. The sample size for the training set
- Not Applicable. This device is a physical medical device, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. As per point 8, there is no training set for this type of device.
In summary: The provided text is a 510(k) summary for regulatory clearance, which focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing and comparison of characteristics. It does not provide information about clinical trials, user studies, or AI algorithm performance, which would typically involve the requested details on acceptance criteria, sample sizes, expert ground truth, and adjudication methods for clinical performance.
§ 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.)