# K191986: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Nov 10, 2019 after 108 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: 17 generations back to K960026 (1996). 320 ancestors in all.
38 later devices descend from it; 9 cite it directly.
0 of 359 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 4.
- K173908: DESS Dental Smart Solutions, Terrats Medical SL (2018) Summary page 4.
- K161416: Multi-unit Abutment Plus, Nobel Biocare AB (2017) Summary page 4.

## Most influential descendants
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own
- K212577: DESS Dental Smart Solutions (2021), 19 descendants of its own
- K203464: DESS Dental Smart Solutions (2021), 15 descendants of its own
- K222288: DESS Dental Smart Solutions (2022), 14 descendants of its own
- K202026: Blue Sky Bio CAD-CAM Abutments (2020), 11 descendants of its own

## 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 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/K191986
Methodology: https://510kreport.com/methodology