(90 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 Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.
The purpose of this submission is to expand the DESS Dental Smart Solutions abutment system cleared under K170588, K173908, K191986, K203464, K212577, and K212628 to:
- include new OEM platform compatibilities (that have not been previously cleared) for previously ● cleared DESS designs,
- include previously-cleared OEM platform compatibilities for previously-cleared DESS abutment ● designs for which the specific combinations of compatibility and design were not cleared previously,
- add angulation to previously cleared Ti Base Abutments, Pre-Milled Blank, Ti, and Multi Unit Abutment,
- include a new abutment design, ZRN Multi Unit Abutment,
- include additional gingival height variations for the Ti Base Interface and DESSLoc Abutment, ●
- include two attachments: Interface Attachment for UniAbutment and Bar Attachment. ●
This submission includes five (5) abutment designs [Healing Abutments, Temporary Abutments, Multi Unit Abutments (straight and angled), ZRN Multi Unit Abutments (straight and angled), and DESSLoc Abutments], one (1) abutment blank (Pre-Milled Blank, Ti), three (3) base designs (Ti Base, C-Base, CrCo Base), two (2) attachments, and twenty (20) screws.
This submission includes one (1) new abutment design (ZRN Multi Unit abutment), based on the previously cleared Multi Unit abutment, but with an added zirconium nitride (Zr\V) coating. The identical coating is used on the DESSLoc Abutments that have been cleared in K170588, and K212628.
This submission includes two attachments. The subject device Interface Attachment for UniAbutment attaches directly to the UniAbutments and is similar to the Interface Attachment for UniAbutment in K170588. The subject device DESSLoc for Bar is designed to attached directly to the bar. The top portion of this attachment has the same design and material as the DESSLoc abutment cleared in K170588. K191986, and K212628.
The subject device includes the addition of new and previously cleared OEM compatibilities to previously cleared abutment design (Healing Abutments, Temporary Abutments, Ti Base, C-Base, Pre-Milled Blank Ti, Multi Unit abutments, and DESSLoc abutment). New compatibility is introduced for four (4) implant systems for which Terrats Medical has no prior clearance, for a total of eleven (11) new platforms. The direct correlation between each subject device design and the corresponding compatible implant platforms is shown in Summary of Subject Device Components and Implant Platforms for Compatible Implant Systems.
The subject device DESS Dental Smart Solutions provides a range of prosthetic solutions for dental implant restoration. DESS abutments, bases and blanks are offered in a variety of connection types to enable compatibility with currently marketed dental implants. Abutments are provided with the appropriate abutment screw (if applicable) for attachment to the corresponding implant, and the appropriate prosthetic screw (if applicable) for attachment of a screw-retained prosthesis. All abutments and screws are provided non-sterile.
The document provided is a 510(k) Pre-market Notification for a dental device (DESS Dental Smart Solutions abutments). It focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a study to prove performance against specific acceptance criteria for a novel AI/software component.
Therefore, the tables and information requested regarding acceptance criteria, study design (sample size, ground truth, expert adjudication, MRMC studies, standalone performance), and training set details are not present in this document.
This type of submission typically demonstrates that a new version of an existing device (e.g., with expanded compatibilities, minor design variations, or new materials) is as safe and effective as a legally marketed predicate device. The performance data section explicitly states: "No clinical data were included in this submission." The non-clinical data primarily involve sterilization validation, biocompatibility, and reverse engineering analysis to confirm compatibility, all leveraged from previous clearances.
In summary, this document does not contain the information necessary to fulfill the request concerning acceptance criteria for an AI/software device and the study proving it meets those criteria.
§ 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.)