# K252384: DESS® Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Oct 23, 2025 after 84 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). 328 ancestors in all.
No later device cites it as a predicate yet.
0 of 329 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242340: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 6.

## 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® Pre-Milled Blank abutments are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems for Pre-Milled Abutments Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm Astra Tech EV (Internal Taper) | 3.0, 3.6, 4.2 | 3.0, 3.6, 4.2 BioHorizons Internal (Internal Hex) | 3.0, 3.4, 3.8; 3.8, 4.2, 4.6; 4.6, 5.2, 5.8 | 3.0; 3.5; 4.5 Simply Iconic™ (Internal Conical) | 3.2, 3.7, 4.2, 4.7; 4.7, 5.2, 5.7 | 3.0; 3.4 InterActive (Internal Conical) | 3.2, 3.7; 4.3, 5.0 | 3.0; 3.4 Legacy™1 (Internal Hex) | 3.7, 4.2; 4.7 | 3.5; 4.5 Legacy™2, simplyLegacy™2, Legacy™3, simplyLegacy™3, Legacy™4 (Internal Hex) | 3.2; 3.7, 4.2; 4.7, 5.2 | 3.0; 3.5; 4.5 Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM Nobel Biocare NobelActive® (Conical Connection) | 3.0; 3.5; 4.3, 5.0 | 3.0; NP (3.5); RP (3.9) NobelReplace Conical Connection (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9) NobelParallel Conical Connection (Conical Connection) | 3.75; 4.3, 5.0 | NP (3.5); RP (3.9) Osstem® TS | 3.5 | Mini Hiossen® ET (Internal Taper) | 4.0, 4.5, 5.0, 5.5, 6.0, 7.0 | Regular Straumann Bone Level (CrossFit® Morse Taper) | 3.3; 4.1, 4.8 | NC; RC Straumann BLX (TorcFit™ Internal Hexalobular) | 3.5, 3.75, 4.0, 4.5; 5.0, 5.5, 6.5 | RB; WB Zimmer Screw-Vent® Tapered Screw-Vent® (Internal Hex) | 3.3, 3.7, 4.1; 4.7 | 3.5; 4.5 Compatible Implant Systems for Multi-Unit Abutments Compatible Implant System (Connection) | Implant Body Diameter, mm | Implant Platform, mm Biomet 3i OSSEOTITE® (External Hex) | 3.25; 3.75, 4.0 | 3.4; 4.1 InterActive (Internal Conical) | 3.2, 3.7; 4.3, 5.0 | 3.0; 3.4 Simply Iconic™ (Internal Conical) | 3.2, 3.7, 4.2, 4.7; 4.7, 5.2, 5.7 | 3.0; 3.4 Legacy™1 (Internal Hex) | 3.7, 4.2; 4.7 | 3.5; 4.5 Legacy™2, simplyLegacy™2, Legacy™3, simplyLegacy™3, Legacy™4 (Internal Hex) | 3.2; 3.7, 4.2; 4.7, 5.2 | 3.0; 3.5; 4.5 Neodent GM (Morse taper) | 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 | GM Nobel Biocare NobelActive® (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9) NobelReplace Conical Connection (Conical Connection) | 3.5; 4.3, 5.0 | NP (3.5); RP (3.9) NobelParallel Conical Connection (Conical Connection) | 3.75; 4.3, 5.0 | NP (3.5); RP (3.9) Straumann Bone Level (CrossFit® Morse Taper) | 3.3; 4.1, 4.8 | NC; RC

Source page: https://510kreport.com/device/K252384
Methodology: https://510kreport.com/methodology