# K231434: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Aug 14, 2023 after 89 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: 21 generations back to K960026 (1996). 325 ancestors in all.
No later device cites it as a predicate yet.
0 of 326 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230143: DESS Dental Smart Solutions, Terrats Medical SL (2023) Summary page 4.

## 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. Implant Systems Compatibility Internal Hex Connections Zimmer 3.1mmD Eztetic™ Zimmer Screw-Vent® Zimmer Tapered Screw-Vent® TSX™ Implant System TSX™ Implant System, 3.1mmD External Hex Connections Biomet 3i OSSEOTITE® Implants

Source page: https://510kreport.com/device/K231434
Methodology: https://510kreport.com/methodology