# K222269: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Oct 26, 2022 after 90 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: 19 generations back to K960026 (1996). 323 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K212628: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 4.
- K212577: DESS Dental Smart Solutions, Terrats Medical SL (2021) Summary page 4.
- K173908: DESS Dental Smart Solutions, Terrats Medical SL (2018) Summary page 4.

## Most influential descendants
- K230143: DESS Dental Smart Solutions (2023), 1 descendant of its own
- K260564: DESS Dental Smart Solutions (2026), 0 descendants of its own
- K231434: DESS Dental Smart Solutions (2023), 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 Blanks are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems PRIMA CONNEX (Internal TiLobe, Tapered & Straight): Implant body diameter 3.3, 3.5 mm; implant platform 3.5. Implant body diameter 4.0, 4.1 mm; implant platform 4.1. Implant body diameter 5.0 mm; implant platform 5.0. GENESIS (Internal TiLobe): Implant body diameter 3.5, 3.8 mm; implant platform 3.5/3.8. Implant body diameter 4.5 mm; implant platform 4.5. Implant body diameter 5.5, 6.5 mm; implant platform 5.5/6.5. MOLARIS TILOBEMAXX (Internal TiLobe): Implant body diameter 7 mm; implant platform 5.7. Implant body diameter 8 mm; implant platform 6.5. Implant body diameter 9 mm; implant platform 7.5. MOLARIS I-HEXMRT (Internal Hex): Implant body diameter 7 mm; implant platform 5.7. Implant body diameter 8 mm; implant platform 6.5. Implant body diameter 9 mm; implant platform 7.5. PALTOP ADVANCED CLASSIC (Internal Hex): Implant body diameter 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0). PALTOP ADVANCED PLUS (Internal Hex): Implant body diameter 3.0, 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0). Implant body diameter 6.0 mm; implant platform WP (6.0). PALTOP DYNAMIC (Internal Hex): Implant body diameter 3.0, 3.25 mm; implant platform NP (3.25). Implant body diameter 3.75, 4.2, 5.0 mm; implant platform SP (3.75/4.2/5.0). Implant body diameter 6.0 mm; implant platform WP (6.0). PALTOP DYNAMIC CONICAL (Internal Conical): Implant body diameter 3.25, 3.75, 4.2, 5.0 mm; implant platform CC (3.25/3.75/4.2/5.0).

Source page: https://510kreport.com/device/K222269
Methodology: https://510kreport.com/methodology