(311 days)
The BTI Dental Implant System UnicCa® for oral implant surgery is to be used for the partial or total replacement of teeth in edentulate patients. Once attached to the bone, the implants act as an anchor for various fixed or removable prosthetic solutions that can be used to improve or restore a patient's mastication function.
In the case of 5.5 – 6.5mm long UnicCa® implants should be used in a two-stage surgical procedure. These implants are indicated for delayed loading. These implants are indicated only for straight abutments and to support permanently fixed restorations.
In the case of Tiny® 3.0 UnicCa® implants: These implants shall be used only to replace maxillary lateral incisors and mandibular lateral and central incisors. Immediate loading is recommended when there is good primary stability and an appropriate occlusal load.
The BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided with two types of connections; external (i.e., Externa®) and internal (i.e., Interna®), in a variety of platforms and range of diameters (3.0 - 6.0 mm) and lengths (5.5 - 18.0 mm). BTI Dental Implant System UnicCa® features an implant surface treatment that improves the hydrophilicity of the implant.
The purpose of this 510(k) is to allow B.T.I. to expand the product offering for the Wide and Universal Plus 5.5 mm and 6.0 mm diameter Interna® implants to extend implant length up to 15 mm.
This document is an FDA 510(k) summary for the BTI Dental Implant System UnicCa®, which is a dental implant system. The submission describes modifications to the existing device, specifically expanding the available dimensions (diameter and length) of certain implants. Importantly, this is a modification of an already cleared device (predicate K151391), and the document emphasizes substantial equivalence rather than presenting an entirely new device's performance data.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance
Strict acceptance criteria and performance data for the modified device itself are not explicitly presented as a pass/fail table in the document. Instead, the document relies heavily on demonstrating substantial equivalence to a previously cleared predicate device (K151391) and other reference predicates. The "performance data" provided relates to general device safety and effectiveness based on established standards and previous clearances, rather than a novel statistically powered study for the dimensional changes.
However, based on the provided text, we can infer the following:
| Acceptance Criteria Category | Specific Criteria (Inferred from standards/predicate) | Reported Device Performance (as stated or inferred) |
|---|---|---|
| Biocompatibility | Conformance to ISO 10993-1:2009 | Biocompatibility was established within BTI Dental Implant System UnicCa® 510(k) K151391. No changes in materials, so previous testing is directly applicable. Tests performed included Cytotoxicity (ISO 10993-5), Delayed Hypersensitivity (ISO 10993-10), Intracutaneous Reactivity (ISO 10993-10), Acute Systemic Toxicity (ISO 10993-11), and Wetting Solution (ISO 10993-17). |
| Mechanical Properties | Fatigue (EN ISO 14801:2008) | Bench testing (including fatigue per EN ISO 14801:2008) was presented in previous 510(k) K151391. Based on risk analysis, previous testing encompasses the size range extension. Performance is "Equivalent; platform (diameter and length) dependent" to the predicate. |
| Corrosion Testing | Bench testing (corrosion testing) was presented in previous 510(k) K151391. | |
| Material (ISO 5832-2 and ASTM F67) | Material (Commercially pure titanium grade 4) is in compliance with ISO 5832-2 and ASTM F67. | |
| Surface Characteristics | Surface Hydrophilicity TOF SIMS Analysis | Bench testing (Surface Hydrophilicity TOF SIMS Analysis) was presented in previous 510(k) K151391. |
| Roughness (Sq, Sdr values for Neck, Thread, Valleys) | Roughness values are consistent with the predicate (Sq=0.7±0.1 µm, Sdr=50±10% for Neck; Sq≥1.2 µm, Sdr≥200% for Thread; Sq=1.0±0.2 µm, Sdr=85±15% for Valleys). | |
| Sterilization | Sterility Assurance Level (SAL) of 10^-6 | Sterilization validation (gamma radiation) successfully concluded that the process can reliably sterilize to SAL of 10^-6. Process unchanged from K151391. |
| Bacterial Endotoxin (ANSI ST72, USP, USP) | Limulus Amebocyte Lysate (LAL) tests yielded EU/Device value less than acceptance criteria of 20 EU/Device. | |
| Packaging & Shelf-Life | Packaging integrity and 5-year shelf-life | Shelf-life and package integrity were validated previously (K151391) for 5 years (accelerated studies, with 2 years real-time data ongoing). All packaging aspects are identical. |
| Human Factors | Adequate for use in dental setting, maintains sterility | Human Factors study concluded that the tested single-barrier packaging is adequate for use in a dental setting and allows users to maintain sterility. |
2. Sample size used for the test set and the data provenance
The document does not describe specific sample sizes for a new test set for the modified dimensions. The overarching theme is that the modifications (dimensional changes) do not alter the fundamental design, materials, or intended use. Therefore, the data presented relies on previous testing for the predicate device.
- The biocompatibility testing, bench testing (fatigue, corrosion, hydrophilicity), shelf-life validation, and sterilization validation all refer back to studies performed for the predicate device K151391. No new samples or data provenance are explicitly stated for these tests regarding the new extended sizes.
- Human Factors Study: A Human Factors study was performed, but the sample size is not specified. The data provenance is implied to be prospective, specifically assessing the handling of the proposed single-barrier packaging.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable as the document describes a dental implant system, not an AI/diagnostic device that typically requires expert-established ground truth for performance evaluation. The "ground truth" here is compliance with established engineering standards and safety/performance requirements for medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of medical device submission. Adjudication methods are typically used in clinical trial settings or for performance evaluation of diagnostic/AI devices where agreement among experts on a finding is critical.
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
Not applicable. This is a dental implant (hardware), not an AI-assisted diagnostic or imaging device.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's acceptance is primarily based on:
- Compliance with recognized international and national standards (e.g., ISO 10993 series for biocompatibility, EN ISO 14801 for fatigue, ISO 5832-2 and ASTM F67 for material, ANSI ST72, USP, USP for endotoxins).
- Demonstration of substantial equivalence to previously cleared predicate devices through direct comparison of technological characteristics, materials, and intended use.
- Previous performance data from the predicate device (K151391) being deemed applicable to the modified device due to the nature of the changes (dimensional expansion within a similar design).
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 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.