(99 days)
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
IPD Dental Implant Abutments is a dental implant abutment system composed of dental abutments, screws, as well as other dental abutment accessories, intended to be placed into dental implants to provide support for dental prosthetic restorations.
Abutments provide basis for single or multiple tooth prosthetic restorations. They are available in a variety of connection types to enable compatibility with commercially available dental implants systems.
IPD Dental Implant Abutments includes the following categories of dental abutment designs:
- Titanium base (Interface) abutments (INC3D);
- Multi-Unit abutments (MUA);
- Overdenture Abutments (PSD);
- Temporary Abutments (PP);
- Healing Abutments (TC).
The system also includes the use of the corresponding screws intended to attach the prosthesis to the dental implant. Specifically:
- Ti Screw (TT): Used during restoration fabrication.
- TiN Screw (TTN): Used in finished restorations, with TiN coating.
- TPA Screw (TPA): Used in finished angulated restorations, with TiN coating.
The metallic components of the subject abutments and screws are made of titanium alloy conforming to ISO 5832-3 "Implant for surgery – Metallic materials – Part 3: Wrought titanium 6-aluminium 4-vanadium alloy".
The purpose of this submission is to expand IPD Dental Implant Abutments offerings with:
• New IPD's compatible dental implant systems,
• New angulations available abutment-category specific.
• New in-house TiN coating.
IPD dental implant abutments and screws are compatible with the following commercially available dental implant systems:
(Table 2. Summary of IPD abutments categories with compatibilized OEM Implant/Abutment Systems with specific reference to maximum angulation specifically included in this submission. provided in original text)
Ti Base (Interface) abutments are attached (screw-retained) to the implant/abutment and cemented to the zirconia superstructure.
The Ti Base is a two-piece abutment composed of the titanium component, as the bottom-half, and the zirconia superstructure, as the top-half. It consists of a pre-manufactured prosthetic component in Titanium alloy per ISO 5832-3, as well as the supporting digital library file for FDA-cleared design software (3Shape Abutment Designer™ Software, cleared under K151455) which enables the design of a patient-specific superstructure by the laboratory/clinician and which will be manufactured in FDA-cleared Zirconia (e.g., DD Bio Z, K142987) according to digital dentistry workflow at the point of care, or at a dental laboratory.
The design and fabrication of the zirconia superstructure for Ti Base (Interface) will be conducted using a digital dentistry workflow requiring the use of the following equipment, software and materials:
Scanner: 3D Scanner D850.
Design Software: 3Shape Abutment Designer Software, K151455.
Zirconia Material: DD Bio Z, K142987.
Milling machine/Brand: Dental Concept System Model: DC1 Milling System.
Cement: Multilink® Automix, K123397.
Ti Base (Interface) abutment design parameters for the zirconia superstructure are defined as follows:
Minimum gingival height: 1.5 mm
Minimum wall thickness: 0.43 mm
Minimum post height for single-unit restorations: 4.75 mm (1)
Maximum gingival height: 6.0 mm
Maximum angulation of the final abutment 30° (2)
The resulting final prosthetic restoration is screwed to the dental implant. All subject abutments are single-use and provided non-sterile. Final restoration (which includes the corresponding screw) is intended to be sterilized at the dental clinic before it is placed in the patient.
The provided FDA 510(k) clearance letter pertains to IPD Dental Implant Abutments, a medical device, not an AI/ML-driven software product. Therefore, the information requested regarding acceptance criteria and study data for an AI/ML device (e.g., sample size for test/training sets, expert ground truthing, MRMC studies, standalone performance) is not applicable to this document.
The document describes the device, its intended use, comparison to predicate devices, and the non-clinical performance testing conducted to demonstrate substantial equivalence. These tests are physical and chemical in nature, not related to the performance of an AI/ML algorithm.
Here's a breakdown of why an AI/ML-focused response is not possible, based on the provided text:
- Device Type: The device is "IPD Dental Implant Abutments," which are physical components used in dentistry (titanium alloy abutments, screws, designed for zirconia superstructures). It is not software, a diagnostic imaging tool, or an AI/ML algorithm.
- Purpose of Submission: The submission aims to expand compatibility with new dental implant systems and include new angulations and in-house TiN coating. This is a modification of a physical medical device, not a new AI/ML development.
- Performance Data (Section VII): This section explicitly lists non-clinical performance testing such as:
- Sterilization validation (ISO 17665-1)
- Biocompatibility testing (Cytotoxicity, Sensitization, Irritation per ISO 10993)
- Reverse engineering and dimensional analysis for compatibility
- Validation of the digital workflow and software system (but this refers to the CAD/CAM software used to design the physical abutments, not an AI/ML diagnostic tool)
- Static and dynamic fatigue testing (ISO 14801)
- Modified Surfaces Information
- MRI safety review
Conclusion:
The provided document describes a 510(k) clearance for a physical dental implant component. It does not contain any information about the acceptance criteria or study design for an AI/ML driven medical device. Therefore, a table of acceptance criteria and reported device performance related to AI/ML, sample sizes for test/training sets, details on expert ground truthing, MRMC studies, or standalone performance of an algorithm cannot be extracted from this text.
§ 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.)