(138 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.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K221301 to add the ability for the subject device Base Abutments and Pre-milled (Blank) Abutments to be designed using AbutmentCAD software in the digital dentistry workflow, as well as add angulation to some of the Pre-Milled (Blank) Abutments. The subject devices are to Terrats Medical validated milling centers for manufacture, or to be designed and manufactured via a digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, titanium and ceramic material, milling machine, and associated tooling and accessories. The proposed change is to allow the subject devices to be designed using AbutmentCAD by exocad GmbH, the current workflow allows only the use of 3Shape by 3Shape A/S for the design software. Another purpose of this submission is to expand the design parameters to allow angulation (up to 30°) on Pre-milled (Blank) Abutments that are compatible with Neodent Grand Morse, Nobel Active/Nobel Parallel Conical 3.0 mm, and Straumann BLX implants. There are no changes to the abutment design or implant compatibilities. All part numbers have been cleared for manufacturing via a validated milling center and digital dentistry workflows in under K221301.
The subject device DESS Dental 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 validated milling center or a digital dentistry workflow. A validated milling center will be under FDA quality system regulations. The digital dentistry workflow scans files from intra-oral and lab (desktop) scanners, CAD software, titanium and 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 digital workflow includes the following products (not subject devices of this submission):
- Ceramic material: VITA YZ ST and VITA YZ XT (K180703)
- . Cement: Ivoclar Vivadent Multilink Hybrid Abutment Cement (K130436)
- . Intraoral Scanner: 3Shape TRIOS A/S Series Intraoral Scanner (510(k) exempt under 21 CFR 872.3661)
- Desktop scanner: 3Shape D900 Dental Lab Scanner (510(k) exempt under 21 CFR 872.3661)
- Abutment design software: 3Shape Abutment Designer Software (K151455) and AbutmentCAD ● (K193352)
- . Milling machine: VHF R5 by vhf camfacture AG with DentalCAM and DentalCNC 7 software
The provided text describes a 510(k) premarket notification for DESS Dental Smart Solutions, which are dental implant abutments. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device's effectiveness through clinical performance studies with specific statistical acceptance criteria for accuracy, sensitivity, or specificity.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance (in terms of clinical metrics like accuracy, sensitivity, specificity).
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Standalone (algorithm only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
The study described in this document focuses on non-clinical performance data to demonstrate substantial equivalence, specifically:
- Sterilization validation: According to ISO 17665-1, ISO 17665-2, and ISO 14937.
- Biocompatibility testing: According to ISO 10993-5 and ISO 10993-12.
- Fatigue testing and reverse engineering analysis: Of OEM implant bodies, OEM abutments, and OEM abutment screws to confirm compatibility. This includes fatigue testing of OEM implant bodies with patient-specific abutments made at worst-case angled conditions.
- MR Conditional labeling.
- Validation testing of CAM restriction zones: Including verification to show avoidance of damage or modifications of the connection geometry, and locking of restriction zones from user editing in the CAM software.
- Software verification: Included testing of restrictions that prevent design of components outside of the stated design parameters. The abutment design library was validated to demonstrate that established design limitations and specifications are locked and cannot be modified by the user.
The acceptance criteria and reported "performance" for this submission are based on these engineering and design validations, ensuring the device meets safety and performance standards equivalent to the predicate device, K221301. The key "performance" metrics are about maintaining physical and material integrity and compatibility.
The core of the submission is to expand the DESS Dental Smart Solutions abutment system to:
- Allow design using AbutmentCAD software (in addition to 3Shape software).
- Add angulation (up to 30°) to some Pre-milled (Blank) Abutments for specific implant systems.
The document explicitly states: "No clinical data were included in this submission." and "The subject device, the predicate device, and reference devices have the same intended use, technological characteristics, and are materials. The subject device, the predicate device, and reference devices encompass the same range of physical dimensions, manufactured by similar methods, are packaged in similar materials, and are to be sterilized using similar methods. The data included in this submission demonstrate substantial equivalence to the predicate devices listed above."
Therefore, this FDA submission is for a physical medical device (dental implant abutment) and its manufacturing/design software modifications, not an AI or diagnostic device that would involve clinical performance metrics like sensitivity or specificity.
§ 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.)