(243 days)
The REVOIS® Implant System is an implant system recommended for: Surgical placement in the edentulous or partially edentulous jaw bone (upper or lower jaw bone) to create support for prosthetic devices such as single artificial teeth, fixed or removable bridges or dentures. The titanium implant can be applied either in a one-stage surgical procedure with immediate loading when good primary stability is achieved and with appropriate occlusal loading, or in a two-stage surgical procedure (after osseointegration of the implant). Angled abutments on small diameter implants (3.8 mm) of the REVOIS® Implant System are intended for the anterior region of the mouth and not intended for the posterior region of the mouth due to limited strength of the implant.
The REVOIS® Implant System is a self-contained, modular dental implant system for placement into the jaw bone (upper or lower jaw bone) to support prosthetic devices for dental restoration. The system is designed for one-stage or two-stage surgical procedures. The REVOIS® Implant System is composed of a titanium, screw type implant, preassembled with a multifunctional precision abutment and a transfer tool that snaps onto the abutment (Snap-on-tool). The implant is also available with a transfer tool only. A cover screw is contained in the top of the snap-on or transfer tool. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). The REVOIS® Implant System is provided with a number of corresponding tools and surgical instruments, as well as a variety of prosthetic components. For ease of identification the implants and corresponding tools are color coded according to diameter. The main components of the implant system are made of Grade IV or Grade V Titanium (implant, abutment) or plastic (snap-on tool, transfer tool). The materials comply with the ASTM standards ASTM F067 (implant), ASTM F0136-2a (abutment) and ASTM F2026 (Snap-on tool, Transfer tool). The implant surface is blasted with zirconium and then acid-etched for roughness. The REVOIS® titanium implant (pre-assembled with the multifunctional precision abutment and snap-on-tool or with the transfer tool only) is supplied in double sterile packages (sterile inner plastic vial in a sterile glass vial, which is sealed in a blister) and is for single use only. Tools and other re-usable instruments must be sterilized prior to use.
This document is a 510(k) premarket notification for a medical device (REVOIS® Implant System), not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, sample sizes, ground truth establishment, or clinical study results as requested in your prompt.
The 510(k) process is primarily a demonstration of "substantial equivalence" to a predicate device already on the market, rather than a full efficacy study with specific acceptance criteria and performance metrics.
Here's a breakdown of why the requested information isn't present in this document:
- Acceptance Criteria and Reported Device Performance: This document states the device is "substantially equivalent" to predicate devices, implying that its performance is expected to be similar and safe for its intended use, based on comparisons to already cleared devices. It does not provide specific quantitative acceptance criteria or detailed reported performance data (e.g., success rates, failure rates, specific biomechanical measurements with thresholds).
- Study That Proves the Device Meets Acceptance Criteria: No such clinical study is described. The basis for clearance is substantial equivalence (Section 6), which relies on comparing the new device's characteristics (materials, design, intended use, performance aspects) to those of predicate devices.
- Sample Size, Data Provenance, Experts, Adjudication, MRMC, Standalone Performance: These are all terms related to clinical trials and performance studies. As this is a 510(k) submission focused on substantial equivalence, such detailed study information is not included. The FDA review letter confirms that this is a 510(k) premarket notification, which does not require approval of a premarket approval application (PMA) – PMAs typically involve extensive clinical data.
- Type of Ground Truth: This concept is relevant for diagnostic devices or AI studies where a definitive "correct answer" is needed for evaluation. For an implant system, "ground truth" would relate to successful osseointegration and long-term function in patients, which isn't detailed in a 510(k) submission.
- Sample Size for Training Set & How Ground Truth for Training Set Was Established: These questions are specific to machine learning/AI studies. The REVOIS® Implant System is a physical medical device, not an AI or software device that relies on training data.
In summary, the provided document demonstrates substantial equivalence to predicate devices, but does not present a study with explicit acceptance criteria and device performance metrics, nor does it involve the type of clinical trial data or AI/ML-specific information requested.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)