(137 days)
The Neodent Implant System is intended to be surgically placed in the bone of the upper or lower jaw to provide support for prosthetic devices such as artificial teeth, to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.
The Facility implant is indicated for replacement of maxillary lateral incisors, mandibular incisors or retention of overdentures.
The purpose of this submission is to expand the Neodent Implant System components cleared under K101945, K123022, and K133592; these submissions included dental implants with a Morse taper (CM) abutment interface, mating abutments, abutment screws, and other associated components. The additions included in this submission are CM Alvim Acqua and Facility Acqua implants, and 17° angled anatomic abutments.
All of the subject device implants are threaded, self-tapping, root form, endosseous dental implants with Morse taper abutment interfaces. The CM Alvim Acqua implants are made from unalloyed titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloved Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700). The Facility Acqua implants are made from titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). All implants have the "Acqua" surface cleared in K133592. The Acqua surface begins with the traditional grit blasted and acid etched endosseous surface (branded "NeoPoros"), which is identical to that used on implants cleared in K101945 and K123022. The NeoPoros surface undergoes additional processing that renders the surface hydrophilic. The CM Alvim Acqua implants are provided in 3.5, 4.3, and 5.0 mm diameters: each diameter is provided in 8, 10, 11.5, 13. and 16 mm lengths. The Facility Acqua implant is provided with a 2.9 mm diameter in 8, 10, 12, 14, and 16 mm lengths.
This submission includes four series of cement-retained abutments intended for single unit prostheses in the esthetic zone. Each series has scalloped margins to follow the gingival contour to provide better esthetic results with the final prosthesis. The series include CM Anatomic and CM Lateral Anatomic abutments, each without and with an internal indexing feature (branded "Exact") at the apical end of the Morse taper connection. All abutments are angled 17°, are provided in 1.5, 2.5, and 3.5 mm gingival heights, and are made from titanium alloy conforming to ASTM F136.
This document is a 510(k) summary for the Neodent Implant System, seeking to expand components cleared under previous applications. The summary details the device's administrative information, intended use, device description, and performance data. It concludes by asserting substantial equivalence to previously marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
The document does not provide a table of acceptance criteria or specific numerical performance metrics for the Neodent Implant System. This submission is for a 510(k) premarket notification, which demonstrates substantial equivalence to existing predicate devices rather than proving performance against specific acceptance criteria for a novel device. The performance data section broadly mentions "biocompatibility, engineering analysis, and dimensional analysis" as submitted non-clinical data, and "Animal histology data were presented comparing predicate devices to the subject devices implanted in sheep tibiae," but no specific results or acceptance criteria for these analyses are provided.
2. Sample sized 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. The document mentions "Animal histology data were presented comparing predicate devices to the subject devices implanted in sheep tibiae." This implies a test set of animals (sheep), but the specific number of animals or implants tested is not provided.
- Data Provenance: The study was conducted on "sheep tibiae," indicating an animal study. The country of origin for the data is not specified in this document. The manufacturer is based in Brazil, but it's not confirmed if the animal studies were conducted there.
- Retrospective or Prospective: Animal studies are typically prospective.
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 information is not provided in the document. The animal histology data would likely have been interpreted by veterinary pathologists or similar experts, but their number and qualifications are not disclosed.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted as part of this submission. This document pertains to a dental implant system (a physical device), not an AI-assisted diagnostic or interpretative system. Therefore, the concept of human readers improving with or without AI assistance is not applicable.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study for an algorithm was not conducted, as this submission is for a physical medical device (dental implants), not a software algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the animal histology data, the ground truth would have been established through pathology/histological analysis of the sheep tibiae after implantation.
8. The sample size for the training set
This information is not applicable/not provided. Dental implants are physical devices, not learned algorithms, so there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
This information is not applicable. As stated above, there is no "training set" for physical dental implants in the machine learning sense. The performance data relies on physical and biological testing.
§ 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.