# K221301: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Mar 9, 2023 after 308 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). 325 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222288: DESS Dental Smart Solutions, Terrats Medical SL (2022). Cleared while this submission was under review Summary page 5.

## Most influential descendants
- K250178: Adin Customized Abutments (2025), 0 descendants of its own
- K250639: DESS Dental Smart Solutions (2025), 0 descendants of its own
- K242542: Medentika CAD/CAM Abutments (2025), 0 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 DESS Bases or Pre-milled Blanks are to be sent to a Terrats Medical validated milling center for manufacture, or to be designed and manufactured according to the digital dentistry workflow. The digital dentistry workflow integrates multiple components: scan files from intra-oral and lab (desktop) scanners, CAD software, CAM software, ceramic material, milling machine, and associated tooling and accessories.

Source page: https://510kreport.com/device/K221301
Methodology: https://510kreport.com/methodology