Search Results

REVOIS PRO 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 (with good primary stability and appropriate occlusal loading) or in a two-stage surgical procedure (after osseointegration of the implant).

The REVOIS® PRO 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® PRO Implant System is composed of a titanium screw type cylindrical implant. It is a screw form implant with cylindrical thread and a progressive thread near the apex. The double thread of the implant body is contiguous with the triple thread (fine thread) at the implant neck. Together with the conical implant body of the REVOIS®: PRO implant, the progressive thread makes sure that the implant is well anchored in the host bone of the alveolar crest. The incremental pitch of the thread upwards evenly distributes the forces so that implants heal well and can be loaded immediately.

The implant system is delivered in a sterile insert blister and comprises an implant, an impression abutment, an impression screw and a cover screw (sterile packed as a set in a blister packaging). The impression screw serves as a connector between impression abutment and implant so that the pre-assembled parts fit tightly into the inlay for sterility reasons. The system offers implants in various diameters and lengths (3.8; 4.3; 5.0 mm diameter; 9; 11; 13; 15 mm lengths). For ease of identification the implants are color coded according to diameter.

The dental abutment portions of the REVOIS® : PRO implant system include several abutments described subsequently:

• Healing Abutments of diameter 4.4 mm and 5.2 mm in height 2 mm, 3mm and 5 mm each, made of Titanium Grade 5
• Standard abutment (incl. retaining screw) of diameter 4,4 mm in height 5 mm and 7 mm each, made of Titanium Grade 5
• Individual aesthetic abutment of diameter 4,4 mm, made of CERAMICOR®, a gold- platinium alloy
• Impression abutment, multi (pre-mounted with impression screw) made of Titanium Grade 5
• Impression abutment open tray of diameter 4.4 mm, made of Titanium Grade 5
• Locator* abutment, made of Titanium Grade 5
• Locatore Replacement set, consists of several components made of plastic and Titanium Grade 5
• Locator® impression coping, made of the Aluminium Alloy 6061
• Dalbot ball attachment of diameter 4.4 mm and in height 3 mm and 5mm, made of Titanium Grade 5

The REVOIS® PRO Implant System is provided with a variety of prosthetic components and tool which are definitely 510(K)-exempt or still cleared by the submission K063106.

The main components of the implant system are made of Grade V Titanium (implant, abutment). The materials comply with the ASTM standards ASTM F067 (implant) and ASTM F0136-2a (abutment). The implant surface is blasted with luminium oxide particles (Corundum) and then acid-etched for micro-roughness.

The REVOIS® PRO titanium implant is sterile packed for single use only. The sterility is indicated by the color on the sterility indicator attached to the inner Tyvek® foil.

The acceptance criteria and study proving the device meets them are not explicitly detailed in the provided text in the format typically expected for AI/medical device performance evaluation reports (e.g., sensitivity, specificity, accuracy against a gold standard).

This document is a 510(k) summary for a dental implant system (REVOIS® PRO Implant System), which primarily focuses on demonstrating substantial equivalence to a previously cleared predicate device, not on presenting novel performance study results for a new AI algorithm.

Here's a breakdown based on the provided text, addressing your questions where possible:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't provide a typical "acceptance criteria" table with performance metrics like accuracy, sensitivity, or specificity. Instead, the "acceptance criteria" for this 510(k) submission are implicitly met by demonstrating substantial equivalence to predicate devices in:

2. Sample Size Used for the Test Set and Data Provenance:

• Sample Size: Not applicable in the context of this 510(k) summary for a dental implant. The "test set" here refers to non-clinical performance testing of mechanical properties:
  • Fatigue Testing was done according to ISO 14801. The standard specifies the number of samples required for fatigue testing, which typically involves a set number of test pieces (e.g., 5-10 samples per condition) to establish fatigue limits. The exact number of implants tested is not specified in the summary but would follow the ISO standard.
  • Bench Testing with Animal Model was also performed. The summary does not specify the number of animals or implants used in this animal model bench test.
• Data Provenance: The document does not explicitly state the country of origin for the non-clinical tests' data, nor whether it was retrospective or prospective. Given that RIEMSER Arzneimittel AG is a German company, it's highly probable the testing was conducted in Germany or Europe. Non-clinical tests like fatigue testing are inherently prospective at the time of execution.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This question is not applicable to this 510(k) summary. The "ground truth" for a dental implant system like this is established through objective engineering and biological testing (mechanical fatigue, biocompatibility, and animal/human clinical studies for osseointegration and loading), not expert consensus on image interpretation or diagnostic accuracy. The listed studies (e.g., FRIATEC, 1998; Cia et al., 2003) are scientific publications and clinical trials, where the "ground truth" for success or failure would be determined by clinical outcomes, radiographic assessment, or histological analysis, as defined by the methodologies of those studies.

4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set:

Not applicable. This is not a study assessing diagnostic accuracy requiring expert adjudication.

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 device is a dental implant, not an AI-powered diagnostic tool. Therefore, no MRMC study or AI assistance evaluation was conducted.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This device is a dental implant.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

For the REVOIS® PRO Implant System, the "ground truth" for its performance and safety is derived from:

• Mechanical Integrity/Fatigue Testing: Compliance with ISO 14801 standards, which inherently defines "ground truth" for mechanical performance.
• Biocompatibility: Conformance to ASTM material standards (ASTM F067, ASTM F0136-2a).
• Bench Testing with Animal Models: Histological and biomechanical outcomes observed in animal models (e.g., osseointegration, bone-implant contact) serve as a form of "ground truth" for biological response before human trials.
• Clinical Outcomes Data (from referenced studies): The numerous referenced studies (e.g., Cia et al., 2003; Striezel et al., 1998) would have established their "ground truth" through clinical success rates, survival rates, bone loss measurements, clinical evaluations by dentists/surgeons, and patient outcomes over time.

8. The Sample Size for the Training Set:

Not applicable. This device is a physical dental implant, not an AI algorithm requiring a training set.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Ask a specific question about this device