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510(k) Data Aggregation
(393 days)
BTI Interna Narrow/Plus Dental Implant System UnicCa
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.
BTI Dental Implant System UnicCa® is a self-tapping, threaded, root form dental titanium implant provided in two types of connections: external (i.e., Externa®) and 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 expand the product offering and include a new dental implant platform (Interna Narrow), and compatible abutments, together with additional implants for the already existing Universal Plus platform. Interna Narrow implants will be offered with implant diameters ranging from 3.3 to 4.75 mm and lengths of 5.5 to 15 mm. Additionally, new implants for the existing Universal Plus platform of diameter 6.0 mm, and lengths of 7.5 to 11.5 mm are included.
This document describes the BTI Interna Narrow/Plus Dental Implant System UnicCa®, which is a dental implant system. The information provided is for a 510(k) premarket notification to the FDA, asserting substantial equivalence to previously cleared predicate devices.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" in the typical sense of numerical thresholds for outcomes. Instead, it demonstrates substantial equivalence to predicate devices through various non-clinical tests and comparisons. The "performance" is largely reported as demonstrating "substantial equivalence" or being "identical" or "similar" to the predicate devices.
| Feature / Test Category | Acceptance Criteria (Implied by Predicate Equivalence) | Reported Device Performance |
|---|---|---|
| Product Classification | Identical product codes (DZE, NHA) and regulation number (21 CFR 872.3640), Class II. | Identical. |
| Indications for Use | Identical to primary predicate device (K151391) for general use in partial/total replacement of teeth, specific uses for 5.5-6.5mm implants (two-stage, delayed loading, straight abutments, fixed restorations), and Tiny® 3.0 implants (maxillary lateral, mandibular lateral/central incisors, immediate loading with good primary stability/appropriate occlusal load). | Identical to primary predicate device. Includes specific indications for 5.5-6.5mm long UnicCa® implants and Tiny® 3.0 UnicCa® implants that match the predicate. |
| Implant Design | Similar designs, sterilization, and packaging as identified predicate devices (K022258, K053355, K061383) for use as dental implants. | Similar designs, sterilization and packaging are included in subject and the identified predicate devices, intended for similar use. |
| Platform Diameter (mm) | Range of implant platform diameters covered by identified predicate devices (e.g., Interna: 4.1, 5.5; Externa: 3.5, 4.1, 5.5). | Similar. A new platform diameter for the Interna connection (Interna Narrow, 3.5 mm) is included, but the range is covered by predicate devices. Interna Universal Plus is identical to predicate. |
| Implant Length (mm) | 5.5 - 18 mm, matching predicate K151391. | Identical (Interna Narrow: 5.5 – 15 mm; Interna Universal Plus: 7.5 – 11.5 mm, which falls within the predicate's 5.5-18 mm range). |
| Implant Body Diameter (mm) | 3.0 - 6.0 mm, matching predicates K151391, K022258, K053355. | Identical (Interna Narrow: 3.3 – 4.75 mm; Interna Universal Plus: 6.0 mm, which falls within the predicate's 3.0-6.0 mm range). |
| Implant Material | Commercially pure titanium (Grade 4). | Identical. |
| Implant Surface Treatment | Calcium surface treatment. | Identical to primary predicate (K151391). |
| Restoration | Single and multiple restorations. | Identical. |
| Connection Design | Engaging, non-engaging. | Identical. |
| Abutment Prosthetic Diameter (mm) | Range of diameters covered by identified predicate devices (K022258, K053355, K061383), e.g., 3.5 - 6.5 mm. | Similar. The subject device's range (3.5 - 5.1 mm) is covered. |
| Abutment Gingival Height (mm) | Range of gingival heights covered by identified predicate and reference devices (K022258, K053355, K061383, K130808), e.g., 1 - 4 mm. | Similar. The subject device's range (0.5 - 4 mm) is covered. |
| Abutment Angulation | Straight (0°) with divergence allowance supported by bench testing. | Identical. Divergence allowance in subject device is supported by bench testing provided. |
| Abutment Material | Commercially pure titanium (Grade 4). | Identical to identified predicate devices. |
| Prosthetic Screws Material | Ti6Al4V, or other materials in predicate (e.g., gold/palladium alloy in K022258). | Identical to K053355 (Ti6Al4V). |
| Packaging, Sterilization, Shelf-Life | Similar packaging and sterilization processes, sterile by gamma irradiation or non-sterile for end-user sterilization. | Similar packaging as the identified predicate devices. Healing abutments/Transepithelial abutments: sterile by gamma irradiation, thermoform tray with peel top lid. Temporary Titanium abutments, Titanium abutments, Healing Caps, Aesthetic Interfaces and Screws: non-sterile, to be sterilized by end user (moist heat), thermosealed bag. |
| Biocompatibility | Conformance with ISO 10993-1, with satisfactory results for all biological endpoints relative to a long-term implant. | All biological endpoints relative to a long-term implant as identified in the FDA guidance have been addressed with satisfactory results. |
| Corrosion, Surface Hydrophilicity, TOF-SIMS | Leveraged from predicate K151391. Performance should be comparable. | Leveraged from K151391. |
| Fatigue Testing | Conformance with ISO 14801 and FDA guidance document, showing substantial equivalence to predicate for intended use. | Test results show that the proposed device is substantially equivalent to the predicate device for its intended use. |
| Comparative Area Analyses (Bone Resorption, Bone-to-Implant Contact) | Subject implants and reference device should show substantial equivalence in these aspects. | Results showed that subject device is substantially equivalent. |
| Sterilization Validation | Sterility assurance level (SAL) of 10-6, according to ISO 11137-1, ISO 11137-2 and ISO 17665-1. | Validation performed to a SAL of 10-6, according to specified ISO standards. |
| Packaging/Sterile Barrier/Shelf-Life Validation | Conformance with ISO 11607-1, ISO 11607-2, ASTM F88, ASTM F1886, ASTM 1929 and ASTM F2096. | Validation performed according to specified ISO and ASTM standards. |
| Transport Validation | Conformance with ISTA 3A. | Validation performed according to ISTA 3A. |
| Endotoxin Testing | Conformance with ANSI/AAMI ST72. | Testing performed according to ANSI/AAMI ST72. |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: The document mentions "Comparative area analyses for full external area and for bone resorption of up to 3 mm have been performed for subject implants and reference device." However, specific numerical sample sizes for this or other non-clinical tests (e.g., fatigue testing, biocompatibility) are not provided.
- Data Provenance: The document does not specify the country of origin for the data or whether it is retrospective or prospective. It refers to manufacturing in Spain (B.T.I. Biotechnology Institute, SL Jose Rivero Qualified Person Leonardo Da Vinci 14, Parque Tecnologico de Alava Minano, Alava 01510 SPAIN). The tests are non-clinical, implying laboratory or bench testing, not human patient data.
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 and not provided as the submission relies on non-clinical, bench testing for substantial equivalence, not clinical study data requiring expert-established ground truth.
4. Adjudication method for the test set:
This information is not applicable and not provided as the submission relies on non-clinical, bench testing.
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. The device is a physical dental implant system, not an AI-assisted diagnostic or therapeutic tool for which an MRMC study would be relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
This is not applicable as the device is a physical dental implant system, not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The "ground truth" for this submission is based on established engineering and biological performance standards (e.g., ISO, ASTM standards, FDA guidance documents) and comparative data to already cleared predicate physical devices. For example:
- Biocompatibility: Conformance with ISO 10993-1.
- Fatigue Testing: Conformance with ISO 14801 and FDA guidance.
- Sterilization Validation: Conformance with ISO 11137 series.
- Physical measurements and material specifications are compared to those of the predicate devices.
8. The sample size for the training set:
This information is not applicable as there is no mention of a "training set" in the context of this physical device submission, which does not involve machine learning or AI models.
9. How the ground truth for the training set was established:
This information is not applicable for the reasons stated in point 8.
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