# K203464: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Aug 4, 2021 after 253 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.
15 later devices descend from it; 1 cites it directly.
0 of 337 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.

## 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
- K251547: DESS Dental Smart Solutions (2025), 1 descendant 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 C-Base abutments are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems Compatible Implant System Implant Body Diameter, mm Implant Platform Ankylos C/X 3.5, 4.5, 5.5 2.52 mm 3.6 2.9 mm Astra Tech EV 4.2 3.5 mm 4.8 4.1 mm 3.5/4.0 3.5/4.0 mm 4.5/5.0 4.5/5.0 mm 3.25 3.45 mm Biomet 3i Certain® 4.0 4.1 mm 5.0 5.0 mm 3.25 3.4 mm Biomet 3i OSSEOTITE® 3.75, 4.0 4.1 mm 5.0 5.0 mm 3.4 3.4 mm 3.8 3.8 mm FRIADENT XiVE® 4.5 4.5 mm 5.5 5.5 mm NobelActive®, 3.5 NP (3.5 mm) NobelReplace/NobelParallel Conical 4.3, 5.0 RP (3.9 mm) 5.5 WP (5.1 mm) NobelReplace® (Internal tri-channel) 3.5 NP (3.5 mm) 4.3 RP (4.3 mm) 5.0 WP (5.0 mm) 6.0 6.0 (6.0 mm) Nobel Brånemark System® 3.3 NP (3.5 mm) 3.75, 4.0 RP (4.1 mm) Osstem TS 4.0, 4.5, 5.0, 6.0, 7.0 Regular (3.35 mm) 3.3 NC (3.3 mm) Straumann® Bone Level 4.1/4.8 RC (4.1/4.8 mm) 3.3, 4.1, 4.8 RN (4.8 mm) Straumann® Tissue Level 4.8 WN (6.5 mm) 3.3, 3.7, 4.1 3.5 mm Zimmer Screw Vent®/ Tapered Screw-Vent® 4.7 4.5 mm 6.0 5.7 mm

Source page: https://510kreport.com/device/K203464
Methodology: https://510kreport.com/methodology