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510(k) Data Aggregation
(255 days)
NobelZygoma TiUltra implants
The NobelZygoma TiUltra implants are endosseous dental implants intended to be surgically placed in the zygomatic bone to support a dental prosthesis in the upper arch, in order to restore patient esthetics and chewing function. The NobelZygoma Implants are appropriate for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
Multi-Unite Abutment Xeal Zygoma
The Multi-unit Abutments Xeal Zygoma are indicated to support the placement of multiple unit, screw-retained prosthetic restorations in the maxilla including full arch dentures.
NobelZygoma Multi-Unite Abutment Xeal Zygoma Screws
The NobelZygoma Multi-Unit Abutment Screws are indicated for use to secure a dental abutment or framework to a dental implant for supporting tooth replacements and are indicated as an aid in prosthetic rehabilitation.
The Subject Device NobelZygoma TiUltra Implant system is composed of three device lines: NobelZygoma TiUltra Implants, Multi-unit Abutments Xeal Zygoma and NobelZygoma Multi-unit Abutment Xeal Zygoma Screws.
The NobelZygoma TiUltra Implants are endosseous dental implants surgically placed in the zygomatic bone to provide support for prosthetic devices. They are used with patients with severe bone resorption in the maxilla to provide multi-point support of the dental reconstruction. The NobelZygoma TiUltra Implants are used to support the rehabilitation of a fully or a partially edentulous maxilla. The Subject Devices are only intended for extra-maxillary placement.
The subject Implants are made from unalloyed titanium grade 4 (ASTM F67) and present a two-level anodized surface with a soluble salt (protective) layer. Two variants of the Implants are available based on the collar angulation: the NobelZygoma 0° and the NobelZygoma 45° TiUltra Implants. The NobelZygoma 0° CC TiUltra Implants feature a conical connection platform with an internal hex (size RP). The NobelZygoma 45° Ext Hex TiUltra Implants include an external hexagonal platform (size RP).
The NobelZygoma TiUltra implants are available in lengths ranging from 30 mm to 60 mm, in 2.5 mm increments. They feature a partially threaded design. The neck portion, measuring 3.6 mm from the platform, and the shaft portion which varies depending on the implant length, are unthreaded. For all implant lengths, threading consistently begins at the apex and extends 18 mm coronally.
The NobelZygoma TiUltra Implants are co-packed with an implant mount, which is attached via a pre-assembled implant mount screw to the platform of the implant.
The Multi-unit Abutments Xeal Zygoma are premanufactured prosthetic components intended to be connected to the compatible NobelZygoma TiUltra Implants to support the placement of a dental prosthesis.
The Multi-unit Abutment (MUA) Xeal Zygoma are made from Titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and feature a non-porous oxide layer with a soluble salt (protective) layer. The Multi-unit Abutments Xeal Zygoma are attached to the respective NobelZygoma TiUltra Implants by the compatible NobelZygoma Multi-unit Abutment Xeal Zygoma Screw.
The Multi-unit Abutment Xeal Zygoma are available in four different angulations (straight or 0°, 17°, 45° and 60°) and in different heights ranging from 3 to 9mm (2mm increase). The 45° and 60° angulations are used with the NobelZygoma 0° TiUltra implants, while the Straight (or 0°) and 17° angulations are compatible with the NobelZygoma 45° TiUltra Implants. The 17° MUA is only available in two heights (3 and 5mm).
The Multi-unit Abutments Xeal Zygoma are provided sterile and co-packed with the respective abutment handle and NobelZygoma Multi-Unit Abutments Xeal Zygoma Screw.
The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are dental implant screws designed to fasten dental implant system components to a dental implant or to another component.
The subject screws are made of titanium alloy (Ti-6Al-4V (90% titanium, 6% aluminum, 4% vanadium, ASTM F136) and are partially DLC-coated. They are available in different design and sizes to fit the different Multi-unit Abutments Xeal Zygoma. The Straight NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are available in four sizes to fit the respective Straight Multi-Unit Abutment heights. The screws for the 45°/60° Multi-Unit Abutments and the 17° Multi-Unit Abutment are only available in one size that fits all abutment sizes.
The NobelZygoma Multi-unit Abutment Xeal Zygoma Screws are co-packed with the compatible Mult-unit Abutment Xeal Zygoma and are also available separately.
The provided document is a 510(k) Clearance Letter from the FDA for the "NobelZygoma TiUltra Implant system." This type of document primarily focuses on establishing substantial equivalence to previously cleared predicate devices, rather than explicitly detailing acceptance criteria and presenting a single, comprehensive study proving the device meets those criteria.
However, the document does contain information about non-clinical and clinical testing performed to support the substantial equivalence claim. I will extract the relevant information to answer your questions to the best of my ability, acknowledging that not all requested details may be explicitly present in this type of regulatory submission summary.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not explicitly list acceptance criteria in a formal table with pass/fail values. Instead, it describes various tests performed and compares the subject device's performance to predicate devices or established standards. The "Reported Device Performance" column reflects the summary of findings from the validation studies described.
| Acceptance Criterion (Inferred from testing) | Reported Device Performance (Summary of Findings) |
|---|---|
| Mechanical Fatigue Performance | Performed at least as well as the defined benchmark reference system in dynamic loading tests (ISO 14801 adapted for zygomatic implants and FDA Guidance). |
| Implant Insertion Torque | Site preparation protocols allow seating implants with equal or less torque than the benchmark reference system. |
| Magnetic Resonance (MR) Safety | Labeled as MR Conditional according to ASTM F2503, based on testing in accordance with relevant ASTM standards and FDA Guidance. |
| Biocompatibility | Verified in accordance with ISO 10993-1 series and FDA Guidance. |
| Packaging Performance | Validated as intended (maintains integrity after simulated transportation and distribution) in accordance with ISO 11607-1, ISO 11607-2, ASTM D4169, ASTM D4332, ASTM F1886, ASTM F2096. |
| Shelf-life | Confirmed at 5 years in accordance with ASTM F1980. |
| Sterilization Validation | Conducted in accordance with ISO 11137-1, ISO 11137-2, ISO 11137-3, AAMI TIR29, and AAMI TIR 35. Achieved SAL 10-6. |
| Endotoxin Pyrogenicity | Endotoxin limit respected through LAL test according to United States Pharmacopeial Convention; periodic monitoring done as per AAMI ST72. |
| Surface Modification/Roughness | Comparative roughness verification (WLI) confirmed the subject devices exhibit a rougher surface at the collar/shaft compared to Reference Device #3. Within roughness range of Reference Device #7 (which has a similar surface technology). |
| Clinical Performance / Implant Survival | Multiple clinical studies and RWE show implant survival rates generally above 90% and up to 100% for various zygomatic implant configurations (including predicate/reference devices). Post-market surveillance data for subject devices showed similar performance in osseointegration complaint rates compared to NobelZygoma TiUnite implants. TiUltra implants overall showed a mean survival rate of 99.5%. |
| Clinical Adverse Events | Reported adverse events (e.g., implant failure, soft tissue recession, inflammation, sinusitis, hematomas, paresthesia, orbital cavity penetration, screw/prosthesis fracture) were managed with appropriate treatments and did not raise new questions of safety and effectiveness, or were comparable to known predicates. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not provide specific sample sizes for the non-clinical tests (fatigue, torque, MR, biocompatibility, packaging, sterilization, endotoxin, surface roughness). These are typically determined by relevant standards.
- For clinical published literature, the sample sizes varied:
- Three studies on non-full arch applications involved 176 similar zygomatic implants.
- Systematic literature review on quad configuration reported data for a mean implant survival rate (implies a larger, unspecified number of cases).
- Two clinical studies involving Nobel Biocare zygomatic implants: n=15 (minimum 79 months follow-up) and n=302 (mean 7.9 years follow-up).
- A total of 40 clinical publications were provided to support the established history of safe clinical use (number of implants/patients unspecified in this summary).
- Seven clinical cases with a total of 16 NobelZygoma TiUltra implants were presented.
- 36 clinical publications on NobelReplace and TiUltra implant family (number of implants/patients unspecified in this summary).
- For clinical published literature, the sample sizes varied:
- Data Provenance:
- Clinical Studies: Published literature (implies peer-reviewed, multi-center, potentially international data).
- Real-world evidence (RWE): Post-market surveillance for the Subject Devices from July 2024 to May 2025. This is prospective data specific to the subject device after initial market introduction (likely under a different clearance or within a broader market).
- Clinical Case Studies: Seven cases presented directly by the submitter.
- The document implies that data from various regions would be included in "published literature" and "post-market surveillance." No specific countries of origin are mentioned beyond "Nobel Biocare" (Sweden/Switzerland) and "Southern Implants (Pty) Ltd" (implies South Africa). The nature of most clinical data is retrospective (published studies, post-market surveillance).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The document does not specify the number of experts used to establish ground truth for the test set (clinical studies). Clinical studies typically rely on diagnoses and assessments made by treating clinicians (dental surgeons, prosthodontists) based on established medical practices and diagnostic criteria, rather than a separate "ground truth" panel for the study itself, unless it's a specific adjudication or consensus study. Such details are usually found within the full study protocols and reports, which are not part of this 510(k) summary.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
The document does not specify any adjudication methods for the clinical data presented. This information would typically be detailed in the methodology sections of the individual clinical studies or systematic reviews referenced, which are not provided in this summary.
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
The document describes a dental implant system (hardware), not an AI-powered diagnostic or assistive tool. Therefore, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human reader improvement with/without AI assistance is not applicable and was not performed.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
This question is not applicable as the device is a dental implant system, not an algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
- Non-Clinical Tests: Ground truth is based on established engineering and materials science principles, international standards (ISO, ASTM), and FDA guidance documents. Performance is evaluated against these benchmarks.
- Clinical Performance Data: Ground truth is primarily based on outcomes data, specifically:
- Implant survival rate: Directly reported as percentage (e.g., 97.4%, 100%, 89.9%, 99.5%).
- Reported adverse events and complications: Clinical observations and diagnoses by treating dentists/surgeons. Resolution of these events are considered outcomes.
- Osseointegration: Inferred from success rates and lack of failure/complaints related to implant stability.
- Patient esthetics and chewing function: These are indications, and clinical data indirectly supports their achievement through successful implant function.
8. The Sample Size for the Training Set
The concept of a "training set" is typically associated with machine learning or AI algorithms. Since this is a physical medical device (dental implant system), it primarily relies on engineering design, materials science, and clinical validation. Therefore, a "training set" in the context of an algorithm is not applicable. The development and testing would involve design iterations and validation studies, but not an algorithmic training process with a distinct training set.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, the concept of a "training set" in the context of an AI/ML algorithm is not applicable to this physical device. Therefore, the establishment of ground truth for such a set is also not applicable. The "ground truth" for the device's design and performance validation is derived from established scientific principles, pre-clinical testing, and clinical outcomes for the device itself and its predicates.
Ask a specific question about this device
(249 days)
JDentalCare Dental Implant System, family names JDEvolution Plus, JDIcon, JDIcon Plus, is intended to replace missing masticatory functional units (teeth) within the maxilla or mandible.
.DentalCare Dental Implant System is comprised of dental implant fixtures and prosthetic devices. It provides a means for prosthetic attachment in single tooth restorations and partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework or to retain overdentures. Prosthetic devices provide support and retention for screw-retained or cemented restorations in mandible and maxilla. JDentalCare Dental Implant System is intended for immediate function on single tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function. When a one-stage surgical approach is applied, the immediately loaded when good primary stability is achieved and the functional load is appropriate.
Implants 20 mm when placed in the maxilla are only indicated for multiple unit restorations in splinted applications that utilize at least two implants.
JDental Care implant system JDIcon 2.75mm D Dental Implant shall only be used to replace maxillary lateral incisors and mandibular lateral and central incisors for single stage or two stage procedures. It is for immediate implantation in extraction sites or implantation in partially healed or completely healed alveolar ridge situations
JDentalCare S.r.l. manufactures Dental Implant Systems made by Endosseous Dental Implants, Abutment and related accessories, in order to support dentist in performing Dental Implant Surgery.
In order to grant Dentists with a wide range of prosthesis solution, the JDentalCare® Dental Implant System are proposed with different trade name within families lines JDEvolution® plus, JDIcon®, JDIcon® plus, characterized mainly by same mechanical and surface treatment solution and different measure of the hexagon in the connection system. All families have the internal hexagon connection.
JDentalCare® Dental Implant System is a two-piece implant made of commercially pure titanium. The body of the implant fixture (Endosseous Dental Implant) is surgically placed in the upper or lower jaw, while the Abutment (several type for several clinical application) is screwed into the fixture to support the prosthesis.
The connection is done through an internal hexagon: abutment and other accessories are exclusively designed for JDentalCare® Dental Implant System.
The provided text is a 510(k) Premarket Notification for a dental implant system. It details the device's description, indications for use, comparison to predicate devices, and performance data. However, it does not contain information about an AI/ML-enabled medical device.
Therefore, I cannot extract information related to acceptance criteria and the study proving the device meets those criteria for an AI/ML device, as the document describes a physical dental implant system and not an AI/ML product.
The sections regarding acceptance criteria, sample sizes, expert involvement, MRMC studies, standalone performance, ground truth, and training sets are all relevant to the evaluation of AI/ML models. Since this document is about a physical medical device (dental implants), these concepts are not applicable in this context.
Ask a specific question about this device
(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.) |
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(191 days)
The Osteon Precision Milled Suprastructure is indicated for attachments in the treatment of partially orfully edentulous for the purpose of restoring chewing function. The Osteon Precision Milled Suprastructures are intended for attachment to a minimum of two (2) abutments.
The Osteon Milled Suprastructure is indicated for compatibility with the following abutment systems:
- · Nobel Biocare Multi Unit Abutment Plus, 4.8mm, max 30°
- · Nobel Biocare Xeal Abutments, 4.8mm, max 30°
- · Nobel Biocare Multi Unit Abutment, 4.8mm, max 30°
- MIS Multi-unit Abutments, 4.8mm
- · C1 Conical Connection Implant System, max 30°
- · V3 Conical Connection Implant System, max 30°
- · Internal Hex Implant System, max 30°
- · Conical Connection, max 30°
- Southern Compact Conical Abutments, 4.8mm
- · MAX Implant System, 0°
- · Provata Implant System, max 30°
- · Deep Conical (DC) Implants, 0°
- · Piccolo Implants, 0°
- · External Hex Implants, max 30°
- · Astra Tech Implant System® Multi Base Abutment EV, 4.8mm, max 30°
- Keystone Multi Unit Abutment, 4.8mm, 0°
- · Neodent GM Mini Conical Abutment, 4.8mm, max 30°
- · Implant Direct GPS® Angled Abutment, 5.0mm, max 30°
- · Dentium SuperLine® Abutments, 4.5-5.5mm, max 30°
- · Zimmer Angled Tapered Abutments, 4.5mm, max 30°
- · Paltop Multi Unit Abutment, 5.0mm, max 17°
The Osteon Precision Milled Suprastructures (also referred as superstructures) are metallic dental restorative device that is intended for attaching by screw retention to dental abutments to aid in the treatment of partial and totally edentulous patients for the purpose of restoring their chewing function. These suprastructures attach to previously-cleared original equipment manufacturers (OEM) dental abutments using the (OEM) prosthetic screws. The abutmentborne subject devices are indicated for placement only on OEM implant/abutment constructs placed according to the labeling of the previously-cleared systems, and not to exceed the maximum angulation allowed for each OEM implant/abutment construct as identified in the Indications for Use Statement of the subject system.
The Osteon Precision Milled Suprastructure is designed for an individual patient from scans of the patient's impression. The suprastructure is manufactured in biocompatible Titanium alloy with the aid of Computer Aided Design (CAD) and Computer Aided Manufacturing (CAM) technology. All CAD/CAM fabrication is performed by Osteon Medical, within our premises.
Osteon Precision Milled Suprastructures facilitate the attachment of both removable and fixed dental prosthesis and hence categorized as type A and type B.
This document is a 510(k) summary for a dental device, the Osteon Precision Milled Suprastructure. It outlines the regulatory process and demonstrates substantial equivalence to predicate devices, rather than presenting a study that proves the device meets specific performance acceptance criteria. Therefore, most of the requested information about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment is not available in this document.
Here's why and what information can be extracted:
- This is a 510(k) submission: The primary goal of a 510(k) is to demonstrate that a new device is "substantially equivalent" to a legally marketed predicate device, not necessarily to prove its performance against a set of novel acceptance criteria through a clinical trial.
- Focus on Substantial Equivalence: The document compares features like indications for use, materials, design, and manufacturing processes to existing devices.
- Non-Clinical Testing Mentioned: The document refers to non-clinical tests performed, but these are primarily for demonstrating compatibility, material safety, and sterility, not performance against specific clinical efficacy or accuracy metrics.
Information that can be extracted or inferred:
1. A table of acceptance criteria and the reported device performance:
This document does not present explicit "acceptance criteria" in the traditional sense of performance metrics for an AI/algorithm-driven device. Instead, it demonstrates similarity to predicate devices based on design specifications and material properties. The "performance" is implicitly deemed acceptable if it's shown to be substantially equivalent to the established predicate devices.
| Feature / Acceptance Criteria (Implied) | Reported Device Performance (Osteon Precision Milled Suprastructure) |
|---|---|
| Regulation Description | Endosseous dental implant abutment (Similar to Predicate) |
| Indications for Use | For attachment to dental abutments in the treatment of partially or fully edentulous jaws for restoring chewing function. Intended for attachment to a minimum of two (2) abutments and compatible with various listed OEM abutment systems. (Similar to Predicate) |
| Device Material | Titanium alloy Ti-6Al-4V (Same as Reference Device K173466) |
| Design/Technology | Single milling blocks (Similar to Predicate) |
| Fixation Method | CAD/CAM milling from single milling blanks (Similar to Predicate) |
| Design/Construction | Abutment-borne (Similar to Predicate) |
| Sterility | Supplied Nonsterile (Similar to Predicate) |
| Target Population | Adult patients (Similar to Predicate) |
| Prescription/OTC | Prescription only (Similar to Predicate) |
| Recommended Cleaning/Maintenance | Proper oral hygiene (Similar to Predicate) |
| Design Specifications (Type A - Removable Prosthesis) | |
| Total Cylinders | Min 2, Max 10 (Similar to Reference Device K173466) |
| Suprastructure Span Between Cylinders | Min 1mm, Max 30mm (Similar to Reference Device K173466) |
| Suprastructure Height | Min 3mm, Max 12mm (Allows wider than Reference Device K173466) |
| Suprastructure Width | Min 3.4mm, Max 12mm (Allows wider than Reference Device K173466) |
| Distal Cantilever Section | Min 0mm, Max 15mm (Similar to Reference Device K173466) |
| Cylinder Height | Min 0mm, Max 4.6mm (Lower max than Reference Device K173466) |
| Cylinder Diameter | Min 4.5mm, Max 8mm (Higher min than Reference Device K173466) |
| Design Specifications (Type B - Fixed Prosthesis) | |
| Total Cylinders | Min 2, Max 10 (Similar to Reference Device K173466) |
| Suprastructure Span Between Cylinders | Min 1mm, Max 30mm (Similar to Reference Device K173466) |
| Suprastructure Height | Min 3mm, Max 22mm (Allows wider than Reference Device K173466) |
| Suprastructure Width | Min 3.4mm, Max 12mm (Allows wider than Reference Device K173466) |
| Distal Cantilever Section | Min 0mm, Max 15mm (Similar to Reference Device K173466) |
(Note: "Similar" indicates that the values or characteristics fall within or are comparable to those of the predicate/reference devices, with stated differences not impacting safety/efficacy from the manufacturer's perspective.)
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable. This submission relies on "non-clinical tests" (dimensional analysis, biocompatibility, sterilization validation) and comparison to existing predicate marketing clearances. It does not describe a "test set" in the context of an AI/ML algorithm evaluation with human interpretation or image analysis. The "test" consists of demonstrating manufacturing conformance and material properties for the physical device.
- Data Provenance: The device is manufactured by Implant Solutions PTY LTD (trading as Osteon Medical) in Mulgrave, Victoria, 3170 Australia. The non-clinical tests (e.g., biocompatibility and sterilization validation) would have been performed there or at certified labs. These are bench tests, not clinical data sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There's no "ground truth" to establish in the context of an AI/ML algorithm or diagnostic accuracy study. The assessment is based on physical device characteristics and established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study requiring adjudication of expert interpretations.
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 physical dental device (suprastructure), not an AI algorithm.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a physical dental device (suprastructure), not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable. The "ground truth" for this medical device submission is compliance with engineering specifications, material standards (e.g., ASTM F136), and validated manufacturing processes, all demonstrated through non-clinical bench testing.
8. The sample size for the training set:
- Not applicable. This is a physical dental device. While it is manufactured using CAD/CAM technology, it does not involve an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established:
- Not applicable. See point 8.
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(251 days)
N1™ TiUltra™ TCC Implant system is indicated for use in the maxilla or mandible for anchoring or supporting prosthetic teeth, in order to restore patient esthetics and chewing function. N1™ TiUltra™ TCC Implant system is indicated for single or multiple unit restorations in splinted or non-splinted applications using a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, given that sufficient primary stability and appropriate occlusal loading for the selected technique has been achieved.
N1 TiUltra TCC Implant system is composed of implant site preparation tools, abutments, and abutment screws.
The provided text describes the regulatory clearance of a dental implant system (N1™ TiUltra™ TCC Implant system) and outlines the testing conducted to demonstrate its substantial equivalence to predicate devices. However, it does not contain information typically found in a clinical study report that would detail acceptance criteria and a study proving the device meets those criteria in the context of diagnostic or screening performance (e.g., sensitivity, specificity, accuracy).
Instead, the document focuses on demonstrating substantial equivalence to legally marketed predicate devices through a comparison of technological characteristics, intended use, indications for use, and comprehensive non-clinical and clinical testing. The concept of "acceptance criteria" here refers to demonstrating that the new device is as safe and effective as the predicate, rather than meeting specific performance metrics for a diagnostic task.
Therefore, I will interpret "acceptance criteria" as the criteria for establishing substantial equivalence and "reported device performance" as the outcomes of the non-clinical and clinical studies conducted to support that equivalence.
Here's a breakdown of the information based on the provided text, addressing your specific questions, with explanations for what is not present:
1. Table of acceptance criteria and the reported device performance
Since this is a submission for substantial equivalence, the "acceptance criteria" are demonstrating similarity to predicate devices and acceptable performance in various non-clinical and clinical tests.
| Acceptance Criteria (for Substantial Equivalence) | Reported Device Performance (N1™ TiUltra™ TCC Implant system) |
|---|---|
| Substantial Equivalence in Intended Use and Indications for Use. | N1™ TiUltra™ TCC Implant system shares the same or similar intended use and indications for use as predicate devices, with differences adequately addressed. |
| Sterilization Validation (SAL 10⁻⁶) | Successfully demonstrated sterility assurance level of 10⁻⁶ via gamma sterilization, confirming safety for use. |
| Endotoxin Levels (meeting USP , , ANSI/AAMI ST72) | Testing confirmed endotoxin levels are within acceptable limits, demonstrating pyrogen-free status. |
| End-User Cleaning & Sterilization Validation (for reusable components) | Validation performed per ISO 17665-1, AAMI TIR12, AAMI/ANSI ST79, ANSI/AAMI ST77, ISO 17664, ensuring safe reprocessing for reusable components. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Packaging Performance (maintaining sterility and device integrity) | Met standards (ISO 11607-1, ASTM D4169, D4332, F1886/F1886M, F2096, F1980), demonstrating packaging efficacy in maintaining sterility and integrity. --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Biocompatibility (ISO 10993-1, -5, -12, -18) | All materials passed biocompatibility tests (cytotoxicity, chemical characterization), confirming safety for patient contact. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mechanical Resistance (ISO 14801, FDA Guidance) | Demonstrated sufficient fatigue resistance and mechanical stability in dynamic loading tests, comparable to predicate devices. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Insertion Parameters (Heat Generation, Torque) | Comparative testing demonstrated equivalence in heat generation and insertion torque to the Primary Predicate, indicating similar surgical experience and bone response. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Osseointegration (Animal Study) | Animal study showed representative osseointegration behavior comparable to the predicate (TiUltra Implants and Xeal Abutments) at 13 ± 2 weeks, supporting the new drilling technique. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Mesostructure Design & Manufacturing (Software & E2E Validation) | Software verification for abutment design library ensured adherence to design limitations; validation confirmed locked specifications, and end-to-end (E2E) validation demonstrated proper manufacturing workflow. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| MR Conditional Labeling (Referencing K212125) | Met acceptable outcomes in MR conditional testing for safe use in specific MR environments, leveraging prior clearance. ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
| Long-term Clinical Performance (MBLC, Survival, Safety, Tissue Health) | Primary Endpoint (MBLC): Non-inferiority to historical data for the predicate device (NobelActive implant system) was met with statistical significance (p |
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(79 days)
NobelProcera Zirconia Implant Bridge (previously cleared per K202452) The NobelProcera® Zirconia Implant Bridge are indicated for use as a bridge anatomically shaped and/or framework in the treatment of partially edentulous jaws for the purpose of restoring chewing function.
TiUltra Implants and Xeal Abutments (previously cleared per K202344) NobelActive TiUltra NobelActive TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting tooth replacements to restore patient esthetics and chewing function. Nobel Active Tilltra implants are indicated for single or multiple unit restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical technique in combination with immediate, early or delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. NobelActive TiUltra 3.0 implants are intended to replace a lateral incisor in the maxilla and/or a central incisor in the mandible. Nobel Active TiUltra 3.0 implants are indicated for single-unit restorations only. NobelReplace CC TiUltra NobelReplace CC TiUltra implants are endosseous dental implants intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. The NobelReplace CC TiUltra implants are indicated for single or multiple unit restorations. The NobelReplace CC Tilltra implants can be used in splinted or non-splications. The NobelReplace CC TiUltra implant may be placed immediately and put into immediate function provided that initial stability requirements detailed in the manual are satisfied. NobelParallel CC TiUltra NobelParallel CC TiUltra implants are endosseous implants intended to be surgically placed in the upper or lower jaw bone for anchoring or supporting replacements to restore patient esthetics and chewing function. NobelParallel CC TiUltra implants are indicated for single or multiple restorations in splinted applications. This can be achieved by a 2-stage or 1-stage surgical techniques in combination with immediate, early of delayed loading protocols, recognizing sufficient primary stability and appropriate occlusal loading for the selected technique. Implants with
Not Found
This document is a 510(k) premarket notification decision letter from the FDA to Nobel Biocare AG regarding their Dental Implant Systems Portfolio - MR Conditional. It explicitly states that the letter covers indications for use and general controls, but does not contain information about acceptance criteria or performance studies for the device itself.
Therefore, I cannot provide the requested information for the following reasons:
- Acceptance Criteria and Performance Data: The document is a regulatory clearance letter, not a clinical study report. It does not contain acceptance criteria for device performance, nor does it present any data from studies proving the device meets particular criteria. The letter confirms substantial equivalence to legally marketed predicate devices, which means the FDA has determined the device is as safe and effective as a previously cleared device, not that specific performance metrics were tested and met in a new study.
- Study Details (Sample size, data provenance, experts, adjudication, MRMC, Standalone, Ground Truth, Training Set): Since no performance study data is included in this FDA 510(k) clearance letter, none of these details can be extracted. The document refers to various previously cleared predicate devices (e.g., K202452, K202344, K181869), but it doesn't describe the studies that led to their clearance.
In summary, the provided text does not contain the information necessary to describe acceptance criteria or a study proving the device meets those criteria.
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