(102 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 purpose of this submission is to expand the Neodent Implant System components cleared under K101207, which included dental implants with an external hex abutment interface. The external hex additions include Titamax Smart EX, and Drive Smart implants that are provided with a new implant mount that can be used as a temporary abutment. Additional straight, angled and ball-type abutments with external hex interfaces are also included in this submission.
All of the subject device external implants are threaded, self-tapping, root form, endosseous dental implants with a grit blasted and acid etched endosseous surface. All implants have a smooth machined collar on the transgingival surface. The Titamax Smart implants are provided in five endosseous thread diameters (3.3, 3.75, 4.0, 4.5, 5.0 mm), three platform diameters (3.3, 4.1, 5.0 mm), and five overall lengths (9, 11, 13, 15, 17 mm). The Titamax Smart EX implants are provided in two endosseous thread diameters (3.75, 4.0 mm), one platform diameter (4.1 mm), and six overall lengths (9, 11, 13, 15, 17, 19 mm). The Drive Smart implants are provided in three endosseous thread diameters (3.5, 4.3, 5.0 mm), three platform diameters (3.3, 4.3, 5.0 mm), and five overall lengths (8, 10, 11.5, 13, 16 mm). All implants are made from commercially pure titanium conforming to ASTM F67.
This submission includes the following abutments: the Smart Mount in three platform diameters (3.3, 4.1/4.3, 5.0 mm); Conical Abutments (platform diameter 3.3 mm); Angled Mini Conical abutments angled 17° or 30°, in four platform diameters (3.3, 4.1, 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; SF Universal Post abutments (platform diameter 4.5 mm); Angled Post abutments angled 17° or 30° in four platform diameters (3.3. 4.1. 4.3, 5.0 mm), and gingival heights from 2 mm to 5 mm; and Equator Attachments for overdentures or partial dentures in three platform diameters (4.1, 4.3, 5.0 mm) and gingival heights from 2 mm to 5 mm. All abutments are made from titanium alloy conforming to ASTM F136.
The Neodent Implant System is a dental implant system designed to support prosthetic devices like artificial teeth to restore chewing function.
1. A table of acceptance criteria and the reported device performance
| Criteria | Acceptance Criteria (Predicate Device K101207, K101945, K123022) | Reported Device Performance (Neodent Implant System) |
|---|---|---|
| Biocompatibility | Demonstrated | Demonstrated |
| Engineering Analysis | Demonstrated | Demonstrated |
| Dimensional Analysis | Demonstrated | Demonstrated |
| Static and Dynamic Compression-Bending Testing (ISO 14801) | Demonstrated equivalence or superiority to predicate devices | Demonstrated equivalence to predicate devices |
| Similar Design and Dimensions | Same range of physical dimensions (diameter, length of implants; diameter, height, angle of abutments) | Similar design and dimensions, same range of physical dimensions |
| Same Materials Used | Implants: Commercially pure titanium (ASTM F67); Abutments: Titanium alloy (ASTM F136) | Implants: Commercially pure titanium (ASTM F67); Abutments: Titanium alloy (ASTM F136) |
| Same Surface | Grit blasted and acid etched endosseous surface; smooth machined collar | Grit blasted and acid etched endosseous surface; smooth machined collar |
| Similar Packaging | Similar to predicate devices | Similar to predicate devices |
| Similar Sterilization Methods | Same materials and processes as predicate devices | Same materials and processes as predicate devices |
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated in the provided text. The submission refers to "non-clinical data" for testing.
- Data Provenance: The document does not specify the country of origin for the non-clinical data. It is a retrospective comparison to previously cleared predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable to this submission. The "ground truth" for demonstrating substantial equivalence relied on engineering and material characteristic comparisons, not expert interpretation of clinical data or images.
4. Adjudication method for the test set
Not applicable. This was a non-clinical equivalence study, not a clinical trial requiring adjudication of patient outcomes or expert diagnoses.
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 submission is for a physical medical device (dental implants and abutments), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used for demonstrating substantial equivalence was based on engineering standards, material specifications, and physical performance testing (e.g., fatigue testing according to ISO 14801), comparing the subject device's attributes to those of legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is a medical device, not a machine learning model, so there is no concept of a "training set" in this context.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
§ 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.