(137 days)
NOVA® Dental Implants System is indicated for use in surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices, such as artificial teeth, in order to restore the patient's chewing function. NOVA® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading.
NOVA® Dental Implants System consists of internal hex dental implants. cover screws and healing caps; abutments system and superstructures; impression copy system & surgical instruments.
Internal hex implants:-
PSI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
PCI implants are provided in diameters: 3.3, 3.75, 4.2, 5 & 6 with lengths 8, 10, 11.5, 13, & 16 mm. (16 mm is not provided for 6 mm diameter).
NOVA Dental Abutments internal hex system provides:
Healing Caps:
HC Series - Narrow (3.75 mm) - Platform height 2,3,4,5,6,7
HC Series - Standard (4.7 mm) - Platform height 2.3.4.5.6.7
HCW Series - Wide (6.00 mm) - Platform height 3,4,5,6
PMI Series - Premium (3.75, 4.7, 6.0 mm) - Platform height 2,3,4,5,6,7
Straight Abutments (Long, straight, narrow, anatomic, curve):
ST Series: Length 8.5, 9.5, 11.5, 12.5 mm.
STA Series: With Shoulder profile height 1, Length 9 mm; profile height 2, Length 10; profile height 3, Length 11; profile height 4 Length 12.
STN: Narrow length 11 mm.
SLM Series: Anatomic Straight Abutment: profile height 1,2,3 length 9,10,11 mm.
SCM Series: Anatomic Straight Abutment: profile height 1.2.3 length 9.10.11 mm.
Angulated Abutments (standard, anatomic, curve):
Standard Angulated Abutment Length 7,9,11 Angulations 15°, 25°.
Anatomic Angulated Abutments Platform height 1,2,3,4 Angulations 15°, 25°.
Anatomic Angulated Curve Platform height 1,2,3, Angulations 15°, 25° .
Ball Attachments Platform height 1.2.3.4.5.6 and related components covers and caps.
Material:
NOVA® Dental Implants System and Dental Abutments System is made of Titanium alloy (Ti-6AI-4V ELI) that conforms to ASTM F136.
The provided document is a 510(k) premarket notification for the NOVA® Dental Implants System. It aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than establishing new acceptance criteria or proving performance through a clinical study.
Therefore, many of the requested details about acceptance criteria and a study proving the device meets those criteria are not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing, predicate devices by comparing their characteristics and performance through non-clinical testing.
Here's what can be extracted and inferred from the document:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, formal "acceptance criteria" for a new, standalone clinical study are not explicitly stated for individual performance metrics in the way you might find in an efficacy trial. Instead, the "acceptance" is based on the new device's performance being comparable to or meeting standards similar to the predicate devices, as demonstrated through various tests.
| Characteristic | Acceptance Criteria (Inferred from Predicate Equivalence) | Reported Device Performance (NOVA® Dental Implants System) |
|---|---|---|
| Biocompatibility | Conform to ISO 7405:2008 (Dentistry Evaluation of biocompatibility of medical devices used in dentistry) and demonstrate no evidence of causing cell lysis or toxicity, equivalent to predicate devices. | Test results demonstrated no evidence of causing cell lysis or toxicity and thus present equivalent performance as its predicate devices. |
| Dynamic Fatigue Strength | Comply with ISO 14801:2007 (Dentistry-Implants-Dynamic fatigue test for endosseous dental implants), demonstrating equivalent fatigue load strength to predicate devices. | Fatigue - Static & Cycling tests conducted comply with ISO 14801:2007. The results demonstrate that the subject devices are substantially equivalent to the predicate devices. |
| Sterilization | Achieve a Sterility Assurance Level (SAL) of 10-6 and meet all testing requirements. | Test results demonstrated that the SAL of 10-6 was achieved and all testing requirements were met. |
| Material Composition | Conform to ASTM F136 (Titanium alloy Ti-6Al-4V ELI) and be identical to predicate devices. | Made of Titanium alloy (Ti-6Al-4V ELI) that conforms to ASTM F136. Shares the same raw material as its predicate devices (GR-5 Titanium Ti-6Al-4V ELI). |
| Primary Stability for Immediate Loading | (Implied to be achieved and maintained upon implantation, comparable to predicate devices stated for immediate loading with good primary stability and appropriate occlusal loading). | Indicated for immediate loading when good primary stability is achieved and with appropriate occlusal loading, similar to predicate devices. (No specific numerical data on primary stability is provided as this is a non-clinical submission). |
| Intended Use / Indication for Use | Equivalent to the predicate devices: surgical and restorative applications for placement in the bone of the upper or lower jaw to provide support for prosthetic devices (artificial teeth) to restore chewing function. Also, for immediate loading when good primary stability is achieved and with appropriate occlusal loading. | Identical to the predicate devices. |
| Technological Characteristics (Design) | Similar to predicate devices: threaded, root form endosseous implants. Internal hex dental implants, cover screws, healing caps, abutments, superstructures, impression copy system, surgical instruments. Dimensions (diameters and lengths) comparable to predicate devices. Surface treatments (sand blast with acid etched, anodized) comparable to predicate devices. | Described as internal hex dental implants with various diameters (3.3, 3.75, 4.2, 5, 6 mm) and lengths (8, 10, 11.5, 13, 16 mm). Includes PCI (straight contour) and PSI (tapered contour) implants. Surface treatment includes sand blast with acid etched and anodized. Shares similarity with predicate devices in design and technological characteristics. |
| Risk Management | Conducted in accordance with ISO 14971:2007. | Risk management process was carried out with accordance to ISO 14971:2007. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. This submission relies on engineering bench tests and comparisons to predicate devices, not patient-based test sets.
- Data Provenance: The document does not specify the country of origin for the data used in the biocompatibility, sterilization, or mechanical tests, nor does it refer to retrospective or prospective patient data. This is a non-clinical submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. "Ground truth" in the context of expert consensus or pathology data is used for clinical studies diagnosing a condition. This document is for a dental implant system being cleared via substantial equivalence, which primarily involves engineering, material, and biocompatibility testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are typically for clinical performance evaluations, especially for diagnostic devices.
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 premarket notification for a physical medical device (dental implants), not an AI-powered diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a physical dental implant and abutment system, not an algorithm or software. No standalone algorithm performance was studied.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The compliance of the device with established international standards (ISO 7405, ISO 5832-3, ISO 14801, ISO 14971), and the direct comparison of its design, materials, and intended use against already cleared predicate devices, serves as the basis for "truth" in this regulatory context of substantial equivalence. This is primarily engineering and material science compliance with standards, and logical deduction for equivalence to predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set, there is no ground truth established for one.
§ 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.