# K243212: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Feb 14, 2025 after 135 days
- Product code: NHA (Abutment, Implant, Dental, Endosseous)
- Device class: 2
- Regulation: 21 CFR 872.3630
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 20 generations back to K960026 (1996). 327 ancestors in all.
No later device cites it as a predicate yet.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 5.
- K173908: DESS Dental Smart Solutions, Terrats Medical SL (2018) Summary page 5.
- K191986: DESS Dental Smart Solutions, Terrats Medical SL (2019) Summary page 5.
- K212628: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 5.
- K222288: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 5.
- K240208: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 5.

## Indications for use
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 Ti Base abutments or Pre-milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture.

Source page: https://510kreport.com/device/K243212
Methodology: https://510kreport.com/methodology