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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.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.