(308 days)
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 Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAM software, ceramic material, milling machine, and associated tooling and accessories.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K22288 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be manufactured via a digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories. There are no changes to the abutment design or implant compatibilities, however, there is a new material for the zircomia superstructure. All part numbers have been cleared within previous submissions for manufacturing at a validated milling center. The purpose of this submission is to allow manufacturing via digital dentistry workflow and to add a new zirconia material for the superstructures of the two-piece abutment.
The subject device DESS Dental Smart Solutions abutments provide a range of prosthetic solutions for dental implant restoration. DESS abutments are offered in a variety of connection types to enable compatibility with currently marketed dental implants. All abutments are provided non-sterile, and each abutment is supplied with the appropriate abutment screw (if applicable) for attachment to the corresponding implant.
Subject device Base Abutments are designed for fabrication of a patient-specific CAD/CAM zirconia superstructure on which a crown may be placed. They are two-piece abutments for which the second part (or top half) is the ceramic superstructure. They also may be used for support of a crown directly on the abutment.
All patient-specific custom abutment fabrication for Base Abutments and Pre-milled (Blank) Abutments is by prescription on the order of the clinician. The subject device Pre-milled (Blank) Abutments and all zirconia superstructures for use with the subject device Ti Base Interface, DESS Aurum Base, ELLIPTIBase, and DESS C-Base will be manufactured using a digital dentistry workflow by using scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The digital dentistry workflow uses scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The provided text is a 510(k) summary for a dental device, specifically DESS Dental Smart Solutions abutments. It focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an AI/ML-based device.
Therefore, I cannot provide the requested information as the document does not contain details about:
- Acceptance criteria for an AI/ML device: This document is about dental implant abutments, not a medical device driven by AI/ML.
- Study proving device meets acceptance criteria: There is no performance study described for an AI/ML component. The "Performance Data" section refers to non-clinical data for biocompatibility and fatigue testing of the physical dental abutments, and software verification to ensure design parameters are met and restriction zones are locked, not AI/ML performance.
- Sample size for test set and data provenance: Not applicable to a non-AI/ML device.
- Number of experts and their qualifications for ground truth: Not applicable.
- Adjudication method for the test set: Not applicable.
- Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable.
- Standalone (algorithm only) performance: Not applicable.
- Type of ground truth used: Not applicable.
- Sample size for training set: Not applicable.
- How ground truth for training set was established: Not applicable.
The document describes the physical characteristics, materials, manufacturing processes (including digital dentistry workflows), and compatibility of the dental abutments, and asserts their substantial equivalence to previously cleared devices. It does not mention any AI/ML components or their performance evaluation.
§ 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.)