(134 days)
DENTIN® 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. DENTIN® Dental Implants System is indicated also for immediate loading when good primary stability is achieved and with appropriate occlusal loading. Two Stage Implants: CLASSIC, RAPID, PRESTIGE. One Stage Implants: ONE PIECE DENTIN® ONEPIECE Implants 3.0 mmd are intended for placement at the mandibular central and lateral incisors and maxillary and lateral incisors. Indicated also for denture stabilization using multiple implants.
DENTIN® Dental Implants System consists of one and two stage endosseous form dental implants, internal hexagonal and one piece implants system; cover screws and healing caps; abutment systems and superstructures; impression copy system & surgical instruments.
This FDA submission for the DENTIN® Dental Implants System (K120530) does not describe a clinical study in the traditional sense, but rather a demonstration of substantial equivalence to predicate devices through various tests and comparisons. Therefore, the concept of "acceptance criteria" is tied to meeting the requirements for substantial equivalence, and "device performance" is demonstrated through compliance with established standards and comparison to predicate devices.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Source/Standard | Device Performance (DENTIN® Dental Implants System) |
|---|---|---|
| Intended Use / Indication for Use | Predicate Devices (K063364, K003191, K103089, K080162, K023113, K062566, K081396, K090347) | "substantially equivalent in terms of intended use, indication for use" to predicate devices. Indicated for surgical and restorative applications in the upper or lower jaw to support prosthetic devices to restore chewing function, including immediate loading when primary stability is achieved. 3.0 mmd ONEPIECE implants for mandibular/maxillary central/lateral incisors and denture stabilization. |
| Technological Characteristics / Design | Predicate Devices | "substantially equivalent in terms of... technological characteristics, performance and user interface." Shares similar design (e.g., tapered implant body contour, self-tapping, internal hex/one-piece options) with predicate devices. |
| Material (Implants) | ISO 5832-3:1996, Predicate Devices | GR-5 Titanium (Ti-6Al-4V ELI) used, which is the same as most predicate devices. Noted difference from NOBELREPLACE (CP4 Titanium) but stated "raises no new issues of safety or effectiveness." |
| Biocompatibility | ISO 7405:2008 | Not explicitly reported as "test results" in the same way as mechanical tests, but compliance with ISO 7405 indicates biocompatibility has been evaluated. The overall claim of no new safety/effectiveness issues implies acceptable biocompatibility. |
| Mechanical Strength (Fatigue - Static & Cycling) | ISO 14801:2007 | "conducted Fatigue - Static & Cycling tests which comply with ISO 14801... The test results have demonstrated the high resistance and high ability with the use of DENTIN Dental Implant System. Therefore, DENTIN® Dental Implants System raises no new issues of safety or effectiveness than the predicate devices." |
| Sterilization | Not explicitly stated standard, but implied industry standards for medical devices | "sterilization tests... were conducted in order to ensure safety and effectiveness... Test results have demonstrated that the SAL of 10-5 was achieved and all testing requirements were met." |
| Shelf Life | Not explicitly stated standard, but implied industry standards for medical devices | "shelf life testing were conducted in order to ensure safety and effectiveness... Test results have demonstrated that... all testing requirements were met." (for shelf life, specifically) |
| Risk Assessment | FDA Guidance Document (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments) | "Risk Assessment was conducted and has demonstrated no new safety and/or effectiveness issues than the predicate devices." |
2. Sample Size for the Test Set and Data Provenance
The submission does not describe a test set in the context of clinical data for a performance study. It relies on bench testing (mechanical, sterilization, shelf-life) to demonstrate compliance with standards and comparison to legally marketed predicate devices for clinical equivalence.
- Bench Testing: The sample sizes for the mechanical, sterilization, and shelf-life tests are not specified in the provided document.
- Data Provenance: Not applicable as no clinical test set data is provided. The tests mentioned are laboratory/bench tests.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. This submission relies on substantial equivalence to predicate devices and adherence to recognized performance standards, not on expert-adjudicated clinical ground truth from a new study.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set with human data requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This type of study (comparing human readers with and without AI assistance) is not mentioned or relevant to this 510(k) submission for dental implants.
6. Standalone (Algorithm Only) Performance Study
No. This is not an AI/algorithm-based device. The device is a physical dental implant system.
7. Type of Ground Truth Used
The "ground truth" for this submission is established through:
- Compliance with recognized standards: ISO 14801 (mechanical fatigue), ISO 7405 (biocompatibility), ISO 5832-3 (material).
- Demonstration of equivalence to predicate devices: The established safety and effectiveness of the legally marketed predicate dental implant systems (Alpha-Bio Tec, MIS Implant Technologies, NOBELREPLACE, Implant Direct SwissPlant, CAMLOG) serve as the clinical "ground truth" for the new DENTIN® system. The submission argues that DENTIN® presents no new safety or effectiveness issues compared to these devices.
- Laboratory test results: Achieving a SAL of 10-5 for sterilization and meeting shelf-life requirements.
8. Sample Size for the Training Set
Not applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.