(116 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 Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to implement a labeling change for certain Pre-milled Blanks of the DESS Dental Smart Solutions abutment system, cleared under K170588, K173908 and K191986, to permit the manufacture of custom abutments with angulation up to 30° and to add three (3) Pre-milled Blanks that also will include such labeling. Design parameters cleared in K170588. K173908 and K191986 were limited to straight abutments only. This change in labeling is for Pre-milled Blanks compatible with three (3) systems: NobelParallel Conical Connection, Straumann Bone Level, and Zimmer Screw-Vent/Tapered Screw-Vent implants. Note that, because NobelActive and Nobel Parallel Conical Connection share the same implant/abutment interface, they are considered one system for purposes of this submission, as they were in K170588, K173908 and K191986. No new compatibilities are added in this submission.
Pre-milled Blanks are designed for fabrication of a custom abutment by a CAD/CAM process. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. Nobelcompatible Pre-milled Blanks are made of titanium alloy (Ti-6A1-4V) conforming to ASTM F136 Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELL (Extra Low Interstitial) Allov for Surgical Implant Applications (UNS R56401) or from cobalt chromium alloy (Co-Cr-Mo) conforming to ASTM F1537 Standard Specification for Wrought Cobalt-28Chromium-6Molybdenum Alloys for Surgical Implants (UNS R31537, UNS R31538, and UNS R31539. Straumann-compatible and Zimmercompatible Pre-milled Blanks are made of titanium alloy (Ti-6Al-4V). They are available in engaging designs and are compatible with the implant systems shown the table below Compatible Implant Systems and Platforms. Except for the maximum angulation of the final abutment and the addition of three (3) Pre-milled Blanks of 14 mm diameter to the previously cleared Pre-milled Blanks of 10 mm and 14 mm diameter, subject device Pre-milled Blanks are identical to Pre-milled Blanks cleared (with slight variations on the name) in K170588, K173908 and K191986. Compatibility with the implant platform was demonstrated in K170588 and K191986.
The design parameters for the CAD/CAM fabrication of custom abutments from subject device Premilled Blanks are:
Minimum wall thickness - 0.45 mm Minimum post height – 4.0 mm
Maximum gingival height - 6.0 mm Minimum gingival height - 0.3 mm Maximum angulation of the final abutment - 30°
Manufacture of CAD/CAM custom abutments from Pre-milled Blanks is to be performed at a Terrats Medical validated milling center.
Here's an analysis of the provided text regarding the acceptance criteria and study for the DESS Dental Smart Solutions, formatted as requested.
The provided document is a 510(k) summary for a medical device (DESS Dental Smart Solutions). It focuses on demonstrating substantial equivalence to previously cleared devices, particularly for a labeling change allowing custom abutments with angulation up to 30 degrees.
It's important to note that this document does not describe a study that proves the device meets acceptance criteria in the way a clinical trial or a detailed performance study report would. Instead, it leverages prior clearances and non-clinical testing to argue for substantial equivalence.
The acceptance criteria provided here are implied by the comparison to predicate devices and the non-clinical testing performed.
1. Table of Acceptance Criteria and Reported Device Performance
Given the nature of a 510(k) submission for an existing device with a labeling change, the "acceptance criteria" are more about demonstrating equivalence and safety/performance as established by the predicate device and relevant standards. The "reported device performance" refers to the results that support this equivalence.
| Acceptance Criteria (Implied) | Reported Device Performance | Comments |
|---|---|---|
| Mechanical Strength & Fatigue Resistance: Device withstands forces encountered during function, demonstrated by meeting ISO 14801 standards for dynamic fatigue. | Non-clinical static and dynamic testing according to ISO 14801 performed. | This testing specifically addressed the change in labeling to allow up to 30° angulation for custom abutments. |
| Biocompatibility: Device materials are safe for use within the human body. | Information leveraged from prior clearances (K170588 and K173908) to demonstrate substantial equivalence. | No new biocompatibility testing was performed for this specific submission as materials were unchanged. |
| Sterilization: Device can be effectively sterilized by the end-user. | Device is to be sterilized by the end-user, same as predicate devices. | This aspect was deemed equivalent to predicate devices. |
| Material Composition: Materials conform to established medical device standards. | Materials (Ti-6Al-4V ELI & Co-Cr-Mo alloy) conform to ASTM F136 and ASTM F1537 standards. | Materials were either identical to or within the scope of materials used in predicate devices. |
| Design Parameters: Custom abutments can be manufactured within safe and functional limits (e.g., wall thickness, post height, gingival height, angulation). | Max angulation up to 30° demonstrated by dynamic testing per ISO 14801 and comparison to reference device K183518. Other parameters (min wall thickness, min/max post/gingival height) are specified and implicitly met based on design validation (not explicitly detailed in this summary). | The key change and associated performance data here is the 30° angulation. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of a dataset of patient images or outcomes. The performance data primarily refers to non-clinical testing (e.g., mechanical tests on physical samples).
- For the ISO 14801 dynamic fatigue testing, the number of physical samples tested is not explicitly stated in this summary. It would typically be a pre-defined number per test arm as per the standard to achieve statistical significance for the specific test.
- Data Provenance: The data provenance mentioned is related to:
- Prior clearances (K170588 and K173908): This refers to previously submitted and cleared devices, implying existing data on biocompatibility and other baseline characteristics. This is a form of retrospective leveraging of previously reviewed data.
- Non-clinical lab testing (ISO 14801): This testing would have been conducted in a laboratory setting, specific to the device design for this submission. The origin (country/lab) of this specific testing isn't mentioned in the summary, but it would be part of the full submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable as the document describes non-clinical performance data and substantial equivalence to predicate devices, not a study involving human expert interpretation of data or images. The "ground truth" here is established by engineering standards (e.g., ISO 14801) and material specifications (e.g., ASTM standards).
4. Adjudication Method for the Test Set
This section is not applicable for the same reasons as point 3. There is no human interpretation or adjudication described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission relies on non-clinical data and substantial equivalence arguments for a physical dental device, not an AI or imaging-related device requiring human reader performance evaluation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This section is not applicable. The device is a physical dental abutment, not an algorithm or software. "Standalone performance" in this context refers to the device's mechanical and material performance characteristics.
7. The Type of Ground Truth Used
The "ground truth" for this device, in terms of its safety and effectiveness, is established by:
- Engineering Standards: Specifically, ISO 14801 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants) for mechanical performance.
- Material Standards: ASTM F136 and ASTM F1537 for material biocompatibility and mechanical properties.
- Predicate Device Performance: The underlying ground truth is based on the previously established safety and effectiveness of the legally marketed predicate devices, which this new device is deemed substantially equivalent to. This is a regulatory "ground truth" rather than a clinical or pathological one.
8. The Sample Size for the Training Set
This section is not applicable. The device is a physical dental abutment, not a machine learning model. There is no "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reasons as point 8.
§ 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.)