Search Results
Found 2 results
510(k) Data Aggregation
(232 days)
Ticare Dental Implant Systems are endosseous dental implanted in the maxilla or mandble jaw bone to serve as a union between the jaw bone and a dental prosthesis for partial or total replacement of teeth in edentulous patients. They are indicated for single-stage or two-stage procedures to support screw-retained restorations and can be used for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Small diameter (3.3mm) implants are indicated to replace a lateral incisor in the maxilla and/or a central incisor in the mandible and should not be used in the molar region. Ti care Osseous Quattro implants are indicated to support permanently fixed restorations.
Ticare Inhex and Osseous implants of 6 mm length are in a two-stage surgical procedure and are indicated for delayed loading to support permanently fixed restorations. These implants are indicated only for straight abutments.
The subject device is a dental implant system including threaded, root-form endosseous dental implants of various diameters and lengths, straight, angled, tapered, UCLA and ball abutments + retention cap as well as healing abutments, cover screws and retaining screws to secure prosthetic restorations. Implants are commercially pure Grade IV titanium except for InHex "Mini" and InHex Quattro "Mini" implants which are Grade V titanium alloy. Abutments and screws are grade V titanium alloy 6Al 4V. Retention cap is Vestakeep D4 R. All implants have an RBM surface. Abutments must be matched to implant design and platform size. Provisional and temporary abutments are for use no more than 2-3 months. Some Inhex abutment designs have a narrow neck alternative version to allow the clinician more choices for soft tissue management.
Osseous dental implants have an external hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13 and 15mm. Standard platform comes in diameters of 3.4, 3.75, and 4.25mm with lengths of 8, 10, 11.5, 13, 15mm (no 8mm in 3.4). There is also a 5.0 standard platform implant which comes in lengths of 6, 8, 10, 11.5, 13 and 15mm. Maxi comes in a diameter of 5.0mm and lengths of 6, 8, 10, 11.5, 13 and 15mm.
InHex dental implants have an internal hex connection and are available in three platforms, standard, mini and maxi. Mini platform comes in a diameter of 3.3mm with lengths of 10, 11.5, 13, 15mm. Standard platform comes in diameters of 3.75, and 4.25mm in lengths of 6 (not in 3.75), 8, 10, 11.5, 13 and 15mm. There is also a 5.0mm diameter implant in standard platform which only comes in a 6mm length. Maxi platform comes in a diameter of 5.0mm with lengths of 9, 10, 11.5, 13, 15mm.
The Osseous Quattro and InHex Quattro implant thread design enables them to be used in softer bone types. Osseous Quattro dental implants have an external hex connection in standard platform and are available in diameters 3.75mm and 4.25mm and lengths of 8, 10, 11.5, 13 and 15mm. InHex Quattro dental implants have an internal hex connection in mini and standard platform and are available in diameters of 3.3mm (mini platform), 3.75mm and lengths 8 (not in 3.3), 10, 11.5, 13 and 15mm.
Maxi platform implants and abutments are for use in the molar region. Mini platform implants and abutments are for use in lateral incisors and lower central incisors. Standard platform implants and abutments are for use in all tooth locations.
Osseous straight abutments come in six designs. Prepable abutments come in hexed with a gingival height of 2mm in standard, mini, and maxi platforms. Tall straight abutments come in hexed with gingival heights of 0.5, 1, 2, 3, 4mm in standard, mini and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard and mini platforms. Multitask abutments comes in maxi platform and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard, mini, and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard platform.
Inhex straight abutments come in six designs. Prepable abutments come in hexed (not in mini) with a gingival height of 2mm in standard, mini, and maxi platforms. There is an additional hexed standard platform prepable abutment with a smooth exterior for cementing. Tall straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3, 4mm (4mm not in mini) in standard, mini and maxi platforms. There are also tall abutments with smooth surfaces for 5.0 implants which come in gingival heights of 3 or 4mm for both standard and maxi platforms. Short straight abutments come in hexed and non-hexed with gingival heights of 0.5, 1, 2, 3mm in standard, mini and maxi platforms. Multitask abutments comes in standard and has a gingival height of 2mm. One piece abutments are non-hexed with gingival heights of 1, 2, 3, 4mm in standard and maxi platforms. Aesthetic abutments are hexed with gingival heights of 3 or 4mm in standard and maxi platform. Inhex narrow neck tall straight abutments hexed and non-hexed come in mini platform with gingival heights of 2, 3mm and maxi & standard platforms with gingival heights of 2, 3, 4mm. Narrow neck short straight abutments hexed come in mini platform with gingival heights of 2, 3m and maxi & standard platforms with gingival heights of 2, 3, 4mm.
Osseous healing screws come in gingival heights of 2, 3, 4, 5, 6, 7mm (no 2mm in mini) in standard, mini, and maxi platforms. Osseous aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. There is an additional model in standard platform which has a tapered seating area.
Inhex healing screws come in gingival heights of 1, 2, 3, 4, 5, 6, 7mm (no 1mm in maxi) in standard and maxi platform. Inhex mini platform healing screws come in gingival heights of 3 or 4mm.There is an additional shorter design of healing screw for 5.0mm implants in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platform. Inhex aesthetic healing screws come in gingival heights of 3, 4, 5, 6, 7mm in standard and maxi platforms. Narrow neck healing screws come in mini platform with gingival heights of 2, 3, 4mm and maxi & standard platform with gingival heights of 2, 3, 4, 5mm.
Osseous angled abutments come in 15° and 20° in standard, maxi, and mini platforms.
Inhex angled abutments come in 15° and 20° in gingival heights of 1, 3, 5mm for standard and maxi platforms and gingival height of 2mm for mini platform. For 5mm implants there is also a shouldered design of 15° and 20° abutment in gingival heights of 1, 3, 5mm for standard and maxi platforms.
Osseous UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, maxi and mini platforms. Osseous UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the gingival collar portion are not intended to be modified.
Inhex UCLA come in hexed and non-hexed in models for casting temporary or permanent abutments in standard, and maxi platforms. Inhex UCLA are for casting straight abutments with a minimum height of 4mm above the gingival collar and with a post height of no more than 9mm. The wall thickness of cast abutments should be at least 0.6mm. The angulation, wall thickness, and diameter of the portion from the gingival collar portion to the bottom of the UCLA are not intended to be modified.
Osseous ball attachments in standard, maxi and mini platforms come in gingival heights of 1, 2, 3, 4, 5.5mm (no 1mm in maxi or mini). The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Inhex ball attachments in standard and maxi platforms come in gingival heights of 1, 2, 3, 4, 5.5mm. The retention cap made of Vestakeep D4 R allows implants to be placed off vertical by no more than 10°. Ball attachments are for multiple restorations only.
Osseous tapered abutments come in six different cone configurations on the top. 10° tapered abutments come in standard platform gingival heights of 2, 3, 4, 5mm with cone type 2, mini platform gingival heights 3, 4, 5mm cone type 1 and maxi platform gingival heights of 2, 3, 4, 5mm with cone type 3. 30° tapered abutments come in gingival heights of 4 or 5mm in standard platform with cone type 4 and maxi platform with cone type 5. Straight tapered abutments come in standard platform with cone type 6 in gingival heights of 2, 3, 4, 5mm. Angled tapered abutments come in standard platform with cone type 6 with 17° in gingival heights 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Inhex tapered abutments come in five of the possible six cone configurations. 10° tapered abutments come in standard platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2 and mini platform gingival heights 1, 2, 3mm in cone type 1. 10° tapered non-hexed abutments come in maxi platform gingival heights 0, 1, 2, 3, 4, 5mm in cone type 2. 30° tapered abutments in cone type 4 gingival heights 1, 2, 3, 4, 5mm come in standard platform and non-hexed maxi platform. Straight tapered abutments in cone type 6 with gingival heights 2, 3, 4, 5mm come in standard and maxi platform. Angled tapered abutments with cone type 6 come in standard and maxi platform with 17° in gingival heights of 2, 3, 4mm and 30° in gingival heights 3, 4, 5mm. Narrow neck 10° tapered abutments come in mini platform with gingival heights of 2, 3mm and standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 10° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments come in standard platform with gingival heights of 2, 3, 4, 5mm. Narrow neck 30° tapered abutments non-hexed come in maxi platform with gingival heights of 2, 3, 4, 5mm. Tapered abutments are for multiple restorations only and for implants which diverge from the occlusion axis by no more than 30°.
Healing abutments for tapered abutments include ones for 10° tapered abutment in standard and maxi platforms which is used with both Osseous and Inhex, angled tapered abutments for Osseous and Inhex, and 30° angled tapered abutment specific ones which fit Osseous maxi platform or Osseous standard and Inhex standard & maxi platforms.
Covers for provisional restoration of tapered abutments come in designs for 10° tapered abutments for Osseous and Inhex, mini and standard platform specific designs for 10° tapered abutments for Osseous and Inhex, and a design for 30° angled tapered abutments for Osseous and Inhex.
Posts for use with tapered abutments come in temporary and permanent restoration versions. Temporary ones come in standard and maxi platform versions for 10° and 30° tapered abutments which can be used with Osseous or Inhex. A temporary restoration post is also available for angled tapered abutments of Osseous or Inhex and an Osseous specific mini platform for 10° tapered abutments. Posts for permanent restoration come in versions for angled tapered abutments used for Osseous and Inhex, 10° tapered abutments used for Osseous and Inhex in standard platform, 30° tapered abutments used for Osseous and Inhex in maxi and standard platforms, non-hexed for 10° tapered abutments used for Osseous and Inhex in maxi platform, and non-hexed for 10° tapered abutment for Osseous mini platform. Titanium interfaces (shorter posts) are available for 10° and 30° tapered abutments for Osseous and Inhex, angled tapered abutments for Osseous and Inhex and 10° tapered abutments for Osseous mini platform.
The provided document is a 510(k) Premarket Notification Submission for Ticare Dental Implant Systems. It is a regulatory document seeking to demonstrate substantial equivalence to legally marketed predicate devices, rather than a study proving the device meets acceptance criteria.
Therefore, the requested information cannot be fully provided as it pertains to a study demonstrating performance against acceptance criteria, which is not the primary focus of this type of regulatory submission.
However, I can extract information regarding the non-clinical testing performed to support substantial equivalence, which serves as a proxy for demonstrating that the device meets certain performance specifications.
Here's a breakdown of what can be inferred and what cannot:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in a direct table format as acceptance criteria vs. specific quantitative performance values for each test. Instead, the document states that tests "met the criteria of the standards" or "demonstrated substantial equivalence."
2. Sample size 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 explicitly stated for each individual test. The document mentions "worst-case scenario" for selection of implants/abutments for certain tests (e.g., shortest implant, largest abutments).
- Data Provenance: Not explicitly stated. The tests were performed by the manufacturer, Mozo Grau, S.A., based in Spain.
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):
This is not applicable as the document describes non-clinical bench testing, not clinical studies involving expert annotation or ground truth establishment in a medical imaging context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as this is related to clinical interpretation and ground truth establishment, which did not occur in this non-clinical 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:
Not applicable. This is a non-clinical submission for a dental implant system, not an AI/software device involving human readers or comparative effectiveness studies of that nature.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable, as this is not an AI/software device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. The "ground truth" in this context is adherence to validated engineering and material standards for dental implants.
8. The sample size for the training set:
Not applicable, as this is not an AI/machine learning model.
9. How the ground truth for the training set was established:
Not applicable.
However, I can summarize the non-clinical testing performed as evidence of meeting performance expectations (implicitly serving as 'acceptance criteria' in a regulatory context for substantial equivalence):
Summary of Non-Clinical Data / Testing Performed:
The Ticare Dental Implant Systems underwent various bench tests to demonstrate conformance to performance specifications and requirements, following the FDA guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Implant Abutments." The results of these tests were reported to have met the criteria of the standards and demonstrated substantial equivalence to the predicate devices.
Non-Clinical Tests Performed (and how they relate to acceptance):
| Test Category | Standard(s) / Description | Reported Performance / Outcome (Implicit Acceptance) |
|---|---|---|
| Mechanical / Durability | Fatigue testing: Under worst-case scenario in accordance with ISO 14801. | "met the criteria of the standards and demonstrated the substantial equivalence with the predicate device." |
| Sterilization | Gamma Sterilization Validation: ISO 11137-1 and ISO 11137-2 (for devices delivered sterile). A Sterility Assurance Level (SAL) of 10^-6 was validated. | "The validation took into account the worst-case scenario, and the results prove equivalence to the predicate device." |
| Steam Sterilization Validation: ISO 17665-1 (for devices delivered non-sterile, e.g., abutments, for end-user sterilization). Two steam sterilizations were conducted on worst-case abutments. | "The results showed equivalence to the predicate device." | |
| Shelf-Life | Shelf-life testing: ASTM F1980 (for accelerated aging of sterile barrier systems and medical devices). | "The worst-case scenario was tested, and the results demonstrated that the devices are equivalent to the predicate devices. The shelf-life is guaranteed up to 5 years, and the devices will function adequately as intended without any degradation during the shelf-life." |
| Packaging Integrity | Packaging Tests: ASTM F88 (seal strength of flexible barrier materials) and ASTM F1929 (dye penetration for seal leaks). | "The results guarantee shelf life up to 5 years under transport and storage conditions during the shelf-life of and USP . Performed on worst-case product. |
| Surface Characterization | SEM (Scanning Electron Microscope) and EDS (Energy-dispersive X-ray spectroscopy): To evaluate final cleaning after surface treatment. | "Implants are completely clean with no residues from the blasting processes on the implant surface, confirming the effectiveness of the cleaning process applied to Mozo Grau dental implants." |
| Dimensional & Mechanical (Short Implants) | Dimensional and mechanical tests: Performed for the shortest implant (6 mm long) from Mozo Grau's system, compared to K172576. This included Bone-to-Implant Contact (BIC) under bone level and 3mm resorption conditions, insertion/removal torque, and pull-out strength. | "All test results have indicated that the subject device is less critical, having more BIC in all conditions, higher insertion and removal torque and higher pull-out forces, indicating favorable substantial equivalence." (i.e., performance met or exceeded predicate/expectations, indicating safety and effectiveness comparable to existing devices). |
| MR Safety | Non-clinical worst-case MRI review: Evaluation of metallic Ticare devices in the MRI environment using scientific rationale and published literature. Rationale addressed magnetically induced displacement force and torque. | This review was performed to support the safety labeling related to MRI compatibility. (No direct "acceptance criteria met" statement, but the performance of the review supports the safe use.) |
Ask a specific question about this device
(72 days)
Dynamic TiBase abutments are intended for use with dental implants as a support for single-unit or multi-unit prostheses in the maxillary or mandibular arch of a partially or fully edentulous patient.
The purpose of this submission is to obtain marketing clearance for Dynamic TiBase, two-piece titanium base abutments that require the fabrication of patient-specific custom zirconia superstructures using CAD-CAM technology. In final, finished form, the subject device abutments are intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half. Each patient-specific zirconia superstructure is individually prescribed by the clinician and manufactured by an authorized milling center.
The provided text is a 510(k) summary for a medical device called "Dynamic TiBase." This summary focuses on demonstrating the substantial equivalence of the device to existing predicate devices, rather than an independent study presenting acceptance criteria and performance data in the typical AI/device sense. Therefore, many of the typical questions for AI performance studies are not applicable.
However, I can extract the relevant information from a regulatory perspective concerning the acceptance criteria and the "study" (which in this context refers to non-clinical testing and comparison to predicates) that proves the device meets regulatory requirements for clearance.
Here's a breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The "acceptance criteria" here are not numerical performance metrics like sensitivity/specificity for AI, but rather regulatory compliance and performance thresholds for mechanical and material properties compared to recognized standards or predicate devices. The "reported device performance" refers to the demonstration that the device meets these standards through testing or comparison.
| Acceptance Criteria Category | Specific Criterion / Standard | Reported Device Performance |
|---|---|---|
| Mechanical Performance | Fatigue strength according to ISO 14801 | Mechanical performance testing of the subject device was performed in conformance to ISO 14801. The fatigue limit data demonstrated that constructs of the subject device abutments fabricated to the limits stated in the proposed labeling, in combination with previously-cleared compatible Biotech Dental, SAS Kontact™ Dental Implant System implants, have sufficient strength for their intended use. Specific effect size is not quantified, but sufficiency for intended use is claimed. |
| Biocompatibility | Conformance to ISO 10993-12 and ISO 19003-51 | Biocompatibility testing according to ISO 10993-12 (referenced from K212108) was performed. Confirmatory biocompatibility testing for finished subject devices made from titanium alloy with cemented zirconia superstructures performed according to ISO 19003-5 and ISO 10993-12 (provided as part of K212108 submission). |
| Sterilization Validation | Conformance to ISO 17665-1 and ISO 11737-2 | Moist heat sterilization validation according to ISO 17665-1 and ISO 11737-2 (referenced from K212108). The device is provided non-sterile and sterilized by the end user via moist heat. |
| MRI Safety | FDA guidance, "Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment" (May 2021) | Non-clinical analysis was performed using scientific rationale and published literature (TO Woods et al. 2021) to evaluate the device in the MR environment. The analysis addressed parameters per the FDA guidance, including magnetically induced displacement force and torque. |
| Material Specifications | ASTM F136 (for Ti-6Al-4V), ISO 5832-3 (for Ti-6Al-4V), ISO 13356 (for Zirconia) | All abutments and abutment screws are made of Ti-6Al-4V conforming to ASTM F136 and ISO 5832-3. Zirconia copings conform to ISO 13356. These are identical materials to the predicate device. |
| Design Parameters (Zirconia Superstructure) | Specific limits for min wall thickness, min post height, max and min gingival height, max angulation. | Parameters are defined: Minimum wall thickness - 0.55 mm; Minimum post height for single-unit restorations - 4.0 mm; Maximum gingival height - 5.37 mm (in the zirconia superstructure); Minimum gingival height - 1.0 mm (in the TiBase); Maximum angulation - 30°. Mechanical testing (ISO 14801) mitigates minor differences in these parameters compared to the predicate. |
| Intended Use / Indications | Substantially equivalent to predicate device K212108 | The Indications for Use Statement (IFUS) for the subject device is substantially equivalent to that of the primary predicate device K212108, with minor differences in compatible implants and milling centers. |
| Device Configuration | Similar to predicate (two-piece abutment, titanium base + CAD-CAM zirconia top-half) | The final finished device is intended to be used as a two-piece abutment composed of the base bottom-half (titanium base) with a bonded CAD-CAM zirconia top-half, which is consistent with the predicate. |
| Implant Compatibility | Compatible with Kontact™ Dental Implant System | Established compatibility with Kontact™ Dental Implant System implants (3.6 mm, 4.2 mm, 4.8 mm, 5.4 mm body/platform diameters) through a business agreement and identical interface connections/platforms as cleared in reference device K210220. |
| Manufacturing Process | Identical to predicate for titanium components | Subject device titanium alloy components are manufactured from identical materials, in the identical facilities using identical manufacturing processes as used for Talladium España, SL products cleared previously in K212108. Anodization process for abutment screws is also identical to previously cleared products. |
1 K212108 submission included confirmatory biocompatibility testing for finished subject devices made from titanium alloy with cemented zirconia superstructures performed according to ISO 19003-5 and ISO 10993-12.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in terms of distinct "samples" for an AI test set. The performance data consists of non-clinical bench testing (static compression and compression fatigue testing) of "worst-case constructs" of the device. The number of constructs tested for ISO 14801 is not explicitly stated but generally involves a statistically significant number of samples to establish fatigue limits. For the MRI safety, it was an analysis based on scientific rationale and published literature, not a test set of physical devices.
- Data Provenance: The document does not specify a country of origin for the test data directly, but the manufacturer is Talladium España, SL (Spain), and the testing was performed to international ISO standards and FDA guidance. The data is retrospective in the sense that it relies on established standards and principles, and some data is referenced from previous clearances (K212108). It is an assessment of the device's physical properties.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable (N/A): This is a non-clinical device clearance based on material science, mechanical testing, and regulatory comparison. There is no "ground truth" established by human experts in the context of diagnostic interpretation or clinical outcomes. The "ground truth" for compliance is essentially the adherence to international standards (ISO) and FDA guidance, which are established by expert committees in their respective fields (e.g., materials science, biomechanics, sterilization).
4. Adjudication Method for the Test Set
- Not Applicable (N/A): As there is no "ground truth" established by human experts in a diagnostic or clinical sense, there is no adjudication method. The compliance is assessed against predefined standards and testing protocols.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: This is not an AI device or a diagnostic device where human reader performance is relevant. It's a dental implant component undergoing physical and material performance evaluation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable (N/A): This is a physical medical device, not an algorithm.
7. The Type of Ground Truth Used
- Referenced Standards and Accepted Testing Methodologies: The "ground truth" for this device's safety and effectiveness is its compliance with established international standards (ISO 14801 for mechanical testing, ISO 10993 for biocompatibility, ISO 17665 and ISO 11737 for sterilization, ASTM F136, ISO 5832-3, ISO 13356 for materials), and FDA guidance for MRI safety. It also relies on the concept of "substantial equivalence" to legally marketed predicate devices, meaning its performance and characteristics are comparable to devices already deemed safe and effective.
8. The Sample Size for the Training Set
- Not Applicable (N/A): This refers to AI algorithms. For this physical device, there is no "training set" in the AI sense. The design and manufacturing processes are developed through engineering and materials science principles, refined over time, and verified through testing.
9. How the Ground Truth for the Training Set was Established
- Not Applicable (N/A): See point 8.
Ask a specific question about this device
Page 1 of 1