(253 days)
DESS Dental Smart Solutions abutments are in conjunction with endosseus dental implants in the maxillary or mandbular arch to provide support for prosthetic restorations.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588 and K191986 to add an additional series of titanium base components for previously cleared OEM implant platform compatibilities. The new components, referred to as C-Base engaging and C-Base non-engaging abutments, are available in a range of abutment gingival heights and abutment platform diameters. This submission includes abutments compatible with 33 implant platforms from 13 implant compatibilities have been cleared in previous Terrats Medical submissions. No new implant compatibilities are added in this submission. Screws used with the subject device C-Base abutments were cleared previously, with the exception of two screws added in this submission. The two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
The subject device DESS Dental Smart Solutions C-Base abutments are similar to TiBase Abutments cleared in K170588 and K191986. C-Base abutments are two-piece abutments designed to support a custom CAD/CAM zirconia superstructure on which a single-unit or multiunit restoration may be placed. The ceramic superstructure produced through CAD/CAM is the second part of the two-piece abutment. The C-Base also may support a ceramic hybrid abutment (direct restoration) in which the crown is included in the design of the zirconia superstructure. They are available either in designs that engage with the anti-rotational feature of the implant or in non-engaging designs for multi-unit restorations. The C-Base post is 4.7 mm high. The gingival height of the abutment (distance from implant platform to abutment platform) ranges from 0.3 mm to 3.0 mm. All patient-specific custom abutment fabrication is by prescription on the order of the clinician. C-Base abutments are made of titanium alloy (Ti-6Al-4V) with anodization and a SelectGrip® surface, described below. When used for a direct crown, a POM burn-out sleeve, an exempt laboratory component that is not a subject of this submission, is available for laboratory fabrication of the prosthesis.
When the C-Base abutment is used with a CAD/CAM zirconia superstructure, or for a direct restoration, design parameters are identical to those cleared in K191986 and in K170588, except that the minimum post height for the subject device is 4.7 mm. The superstructure or direct restoration design parameters are:
Minimum wall thickness – 0.4 mm Minimum post height for single-unit loading - 4.7 mm Minimum gingival height - 0.5 mm Maximum gingival height - 6.0 mm Zirconia superstructures and direct restorations are not intended for angulation correction.
Manufacture of the CAD/CAM zirconia superstructure is to be performed at a Terrats Medical validated milling center, defined as a facility that is registered with FDA as a manufacturer or contract manufacturer.
Each abutment is supplied with the appropriate abutment screw for attachment to the corresponding implant. DESS Dental Smart Solutions screws are designed to attach the abutment or restoration to the implant. With the exception of two new subject device screws, all screws were cleared in previous Terrats Medical submissions. As discussed above, the two screws added in this submission are specific to the Zimmer Screw Vent® / Tapered Screw-Vent® Implants and Ankylos C/X Implants and are not for use with any other previously cleared implant bodies.
All subject device abutments and subject device screws are made of titanium alloy conforming to ASTM F136 Standard Specification for Wrought Titanium-6Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). Zirconia superstructures for C-Base abutments are made of Y-TZP conforming to ISO 13356 Implants for surgery -Ceramic materials based on yttria-stabilized tetragonal zirconia (Y-TZP).
Abutments are colored gold by an anodization process in which the abutment is submerged in an electrolytic solution and exposed to an electric current to achieve the gold color. They also are treated with the SelectGrip® surface to improve adhesion of the cement that is used to attach the superstructure or restoration to the C-Base abutment. The gold anodized surface treatment is identical to that cleared in K191986 and the SelectGrip surface treatment is identical to that cleared in K191986 and K170588. All the subject device components are manufactured from the same materials, are treated with the same surface treatments and are manufactured in the same facilities using the same manufacturing processes as used for the previously cleared predicate devices in K191986 and K170588.
The provided text describes a 510(k) premarket notification for a medical device called "DESS Dental Smart Solutions" (K203464), which are endosseous dental implant abutments. The submission aims to expand the existing product line by adding new titanium base components (C-Base engaging and C-Base non-engaging abutments) compatible with previously cleared OEM implant platforms.
The core of the submission argues for substantial equivalence to predicate devices (K191986 and K170588). This means the device does not require a new approval process if it's shown to be as safe and effective as a legally marketed device. In this context, comprehensive studies with specific acceptance criteria are usually not required in the same way they would be for a novel device. Instead, the focus is on demonstrating that the new device does not introduce new questions of safety or effectiveness.
Here's an analysis based on the provided text for your requested information:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) submission based on substantial equivalence, there are no specific "acceptance criteria" in terms of performance statistics (e.g., sensitivity, specificity, accuracy) that the device must meet, nor are there reported device performance metrics in that sense. Instead, the acceptance criteria are implicit in demonstrating that the new device meets the same safety and effectiveness standards as the predicate devices, which is achieved through a comparison of technological characteristics and non-clinical data.
The "performance" is demonstrated through non-clinical testing and comparison to predicate devices, rather than a standalone clinical efficacy study.
Here's a table summarizing the relevant points:
| Acceptance Criterion (Implicit for Substantial Equivalence) | Reported Device Performance / Justification |
|---|---|
| Material Equivalence | Subject device abutments and screws are made of Ti-6Al-4V ELI (ASTM F136), and zirconia superstructures are made of Y-TZP (ISO 13356). |
| Performance: These materials are identical to those used in the predicate devices (K191986 and K170588), establishing material equivalence and safety. | |
| Biocompatibility | References biocompatibility according to ISO 10993-5 and ISO 10993-12 from the primary and additional predicate devices. |
| Performance: No new biocompatibility testing was performed as the subject device is substantially equivalent to predicate devices regarding materials and processing, indicating safety based on previously established standards. | |
| Sterilization Validation | References sterilization validation according to ISO 17665-1 and ISO 17665-2 from the primary and additional predicate devices. |
| Performance: The device is to be sterilized by the end-user using the same methods as the predicate devices, indicating validated sterilization procedures. | |
| Design Principles & Intended Use Equivalence | The subject device shares similar design principles and identical intended use with the predicate devices: "intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for prosthetic restorations." |
| Performance: Minor dimensional differences (e.g., slightly greater post height of 4.7 mm vs. 4.2 mm, addition of retention grooves, slight taper) do not affect worst-case design parameters or substantial equivalence. Limited new screws were added with minor design changes unrelated to implant compatibility. | |
| Manufacturing Process & Facilities Equivalence | All subject device components are manufactured from the same materials, treated with the same surface treatments, and manufactured in the same facilities using the same processes as previously cleared predicate devices. |
| Performance: Ensures consistent quality and safety standards as established for predicate devices. | |
| CAD/CAM Zirconia Superstructure Design Parameters | Minimum wall thickness – 0.4 mm |
| Minimum post height for single-unit loading - 4.7 mm | |
| Minimum gingival height - 0.5 mm | |
| Maximum gingival height - 6.0 mm | |
| (These parameters are largely consistent with predicates, with slight adjustment to minimum post height to accommodate the new C-Base design without affecting worst-case scenarios). | |
| Performance: These parameters, combined with manufacturing at a Terrats Medical validated milling center, ensure satisfactory design and structural integrity of the final restoration. | |
| Implant System Compatibility (No new compatibilities) | The subject device is compatible with 33 implant platforms from 13 implant compatibilities already cleared in previous Terrats Medical submissions. |
| Performance: Compatibility has been demonstrated in these predicate submissions, and no new compatibility analysis was needed. This confirms the device functions as intended with established implant systems. | |
| Surface Treatments Equivalence | Gold anodized surface treatment (identical to K191986) and SelectGrip® surface treatment (identical to K191986 and K170588). |
| Performance: Ensures the same surface properties, adhesion, and biocompatibility as previously cleared and proven treatments. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document explicitly states, "No clinical data were included in this submission." The evaluation for substantial equivalence relied on non-clinical data (sterilization validation, biocompatibility, reverse engineering analysis). Therefore, there is no "test set" in the sense of patient data for performance evaluation in this submission.
- Data Provenance: The biocompatibility and sterilization validation data referenced are from the predicate devices (K191986 and K170588), which were previously submitted. The reverse engineering analysis was performed on OEM implant bodies, OEM abutments, and OEM abutment screws. The manufacturer, Terrats Medical SL, is located in Barcelona, Spain. The specific country of origin for the referenced predicate data is not detailed, but it would have been part of their previous FDA submissions. The data is retrospective in the sense that it relies on previously generated and accepted data for the predicate devices and existing OEM components.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. As no clinical data or clinical test set was used, there was no need for experts to establish ground truth from patient data. The evaluation was based on engineering and materials science principles, and reference to previously cleared devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. There was no clinical test set requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a dental implant abutment, a physical component, and does not involve AI or "human readers" in its intended use or evaluation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical data, the "ground truth" essentially refers to established engineering standards, material specifications (e.g., ASTM F136, ISO 13356), and regulatory requirements (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization). The substantial equivalence argument relies on the device meeting these established standards, which serve as the implicit "ground truth" for material properties, biocompatibility, and manufacturing quality. The "ground truth" for compatibility was established through reverse engineering analysis of OEM implant bodies and comparison to previously cleared predicate devices.
8. The sample size for the training set
- Not applicable. There is no "training set" in the context of this device, as it is a physical medical device and not a machine learning algorithm.
9. How the ground truth for the training set was established
- Not applicable. As there is no training set, there is no ground truth to establish for it.
§ 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.)