(78 days)
The TITAN Dental Implant System is intended to be surgically placed, either immediately or delayed, in the bone of the maxillary and/or mandibular arch and to provide support for crowns, bridges or overdentures.
The TITAN Dental Implant System is comprised of 26 root-form solid screw-type implant designs and a broad range of abutment designs, all of which are based on existing dental implant systems that are cleared for marketing in the United States. Implant design features include external shapes that are cylindrical (15 designs), tapered (10 designs) and stepped (1 design). Both transgingival and submerged designs are included. External implant thread forms include V, square and buttress designs. Anti-rotational features include external and internal design elements. All implants are made from titanium or titanium alloys conforming to ASTM and ISO standards. Surfaces include as-machined surfaces, grit blasted and acid etched surfaces, surfaces treated with resorbable blast media (RBM) and surfaces coated with plasma-sprayed titanium (TPS) or hydroxyapatite (HA). Diameters range from 3.25 mm to 6.5 mm, and lengths from 5.0 mm to 20.0 mm..
Abutment designs include long and short conical abutments, stepped abutments, gold cylinder abutments, gold/plastic castable abutments and ball head abutments. Antirotational features include external and internal design elements. All abutments are made from titanium or titanium alloys conforming to ASTM and ISO standards or from gold alloy. Surfaces include as-machined surfaces and surfaces treated with titanium nittide. Platform diameters range from 3.25 mm to 6.5 mm.
Abutment screws appropriate to each implant/abutment combination, healing abutments, temporary abutments and laboratory components are included in the TITAN Dental Implant System.
The provided document is a 510(k) premarket notification for the TITAN Dental Implant System. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving clinical efficacy or meeting specific performance acceptance criteria through clinical studies. Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving device meets acceptance criteria, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment.
Instead, the submission focuses on comparing the TITAN Dental Implant System to previously cleared predicate devices based on:
- Intended Use: The same intended use (surgically placed in maxillary/mandibular arch for crowns, bridges, or overdentures).
- Operating Principle: Uses the same operating principle.
- Basic Design: Incorporates the same basic design.
- Materials: Incorporates the same materials (titanium or titanium alloys, gold alloy for abutments).
- Packaging and Sterilization: Uses the same or equivalent materials and processes.
The FDA's review letter confirms that the device is "substantially equivalent" to legally marketed predicate devices, which allows it to proceed to market. This substantial equivalence determination does not involve setting or testing against specific performance acceptance criteria in the way a clinical trial for a novel device would.
Missing Information Summary:
- Table of Acceptance Criteria and Reported Device Performance: Not present. The submission focuses on substantial equivalence to predicate devices, not on proving performance against specific quantitative or qualitative criteria.
- Sample Size and Data Provenance: Not applicable/not present. There is no study described that would require a test set.
- Number of Experts and Qualifications for Ground Truth: Not applicable/not present. No ground truth was established for a performance study.
- Adjudication Method for Test Set: Not applicable/not present.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not conducted or described.
- Standalone Performance: Not conducted or described.
- Type of Ground Truth Used: Not applicable/not present.
- Sample Size for Training Set: Not applicable/not present. This is not an AI/algorithm-based device requiring a training set in the conventional sense.
- How Ground Truth for Training Set Was Established: Not applicable/not present.
§ 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.