Search Results

DESS Dental Smart Solutions abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations.

All digitally designed custom abutments for use with DESS Ti Base abutments and Pre-milled Blank Abutments are to be sent to a Terrats Medical validated milling center for manufacture.

The purpose of this submission is to add components to the DESS Dental Smart Solutions system, which includes dental implants, abutments, and prosthetic components cleared previously in various submissions. The previously cleared abutments and prosthetic components are compatible with a variety of original equipment manufacturer (OEM) dental implants as well as DESS Dental Smart Solutions dental implants. This submission adds various abutments compatible with the Neodent GM implant line.

The subject device abutment designs include Healing Abutments, Ti Base Abutments, AURUM Base Abutments, C-Base Abutments, Multi-Unit Abutments (straight and angled), Cement-retained Abutments (straight and angled), Pre-Milled Blank Abutments, DESSLoc Abutments (Locator-type abutments), and abutment screws.

This document is a 510(k) Summary for a medical device (DESS Dental Smart Solutions). It describes the device, its intended use, a comparison to predicate devices, and the non-clinical data submitted to demonstrate substantial equivalence. It does not contain information about acceptance criteria or studies proving device performance against such criteria in the context of an AI/ML powered device.

Based on the provided text, the device in question is not an AI/ML powered device. It is a set of dental implant abutments and related components. Therefore, the questions related to AI/ML device performance (like acceptance criteria, sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.) are not applicable to this document.

The "Performance Data" section (page 8, {8} in your indexing) details the non-clinical tests performed:

• MR Safety Evaluation: Non-clinical analysis to evaluate the subject devices in the MR environment using scientific rationale and published literature. This included assessing magnetically induced displacement force and torque.
• Mechanical Testing: Conducted according to ISO 14801 to support the performance of the subject device abutments with angulation.
• Biocompatibility: Referenced from previous K-submissions (K240208, K233316, and K222288).
• Sterilization Validation:
  • Moist Heat Sterilization: Referenced from K240208, validated to a sterility assurance level of 10^-6 by the overkill method (ANSI/AAMI/ISO 17665-1 and 17665-2).
  • Gamma Irradiation: Referenced from K240208, validated to a sterility assurance level of 10^-6 using method VDmax25 (ISO 11137-1 and ISO 11137-2).
  • Bacterial Endotoxin Testing: According to ANSI/AAMI ST72, demonstrating < 20 EU/device.
• Shelf Life Testing: Samples tested after accelerated aging equivalent to five (5) years of real-time aging per ASTM F1980, including testing of packaging sterile barrier and sterility.
• Reverse Engineering Dimensional Analysis: Referenced from K212628, used to establish dimensions and tolerances for subject abutments and screws to fit OEM implants, demonstrating compatibility.

The document explicitly states: "No clinical data were included in this submission."

Therefore, I cannot provide the requested table or information because the device described in the provided text is a physical medical device (dental implants and abutments), not an AI/ML-powered one. The acceptance criteria and study designs described in your request are relevant to AI/ML software (like diagnostic algorithms), not to a physical implantable device like this one.

Ask a specific question about this device