# K212577: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Dec 10, 2021 after 116 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: 18 generations back to K960026 (1996). 321 ancestors in all.
19 later devices descend from it; 2 cite it directly.
0 of 341 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191986: DESS Dental Smart Solutions, Terrats Medical SL (2019) Summary page 4.
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 4.
- K173908: DESS Dental Smart Solutions, Terrats Medical SL (2018) Summary page 4.

## Most influential descendants
- K222288: DESS Dental Smart Solutions (2022), 14 descendants of its own
- K242340: DESS Dental Smart Solutions (2024), 3 descendants of its own
- K240982: DESS Dental Smart Solutions (2024), 3 descendants of its own
- K221301: DESS Dental Smart Solutions (2023), 3 descendants of its own
- K222269: DESS Dental Smart Solutions (2022), 3 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 Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems Implant Body Diameter, mm Compatible Implant System Implant Platform 3.5 NP NobelActive®, NobelParallel 4.3, 5.0 RP Conical 5.5 WP 3.3 NC Straumann® Bone Level 4.1/4.8 RC 3.7, 4.1 3.5 Zimmer Screw Vent®/ Tapered 4.7 4.5 Screw-Vent® 6.0 5.7

Source page: https://510kreport.com/device/K212577
Methodology: https://510kreport.com/methodology