# K250639: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: May 22, 2025 after 80 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). 327 ancestors in all.
No later device cites it as a predicate yet.
0 of 328 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K221301: DESS Dental Smart Solutions, Terrats Medical SL (2023) Summary page 6.
- K240982: 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 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. Compatible Implant Systems Implant System Compatibility — Implant Diameter (mm) — Implant Platform Name Ankylos C/X — 3.5, 4.5, 5.5 — 3.5, 4.5, 5.5 3.0 — 3.0 3.6 — 3.6 Astra Tech EV — 4.2 — 4.2 4.8 — 4.8 5.4 — 5.4 3.0 — 3.0 Astra Tech OsseoSpeedTM — 3.5/4.0 — 3.5/4.0 4.5/5.0 — 4.5/5.0 BioHorizons Internal — 3.0, 3.4, 3.8 — 3.0 3.8, 4.6 — 3.5 4.6, 5.8 — 4.5 5.8 — 5.7 Biomet 3i Certain® — 3.25 — 3.4 4.0 — 4.1 5.0 — 5.0 Biomet 3i OSSEOTITE® — 3.25 — 3.4 3.75, 4.0 — 4.1 5.0 — 5.0 Camlog — 3.3 — 3.3 3.8 — 3.8 4.3 — 4.3 5.0 — 5.0 Friadent XiVE® — 3.4 — 3.4 3.8 — 3.8 4.5 — 4.5 5.5 — 5.5 MegaGen AnyRidge — 3.5, 4.0, 4.5, 5.0, 5.5 — 3.5 Neodent Grand Morse — 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 — Grand Morse (GM) 3.0 — 3.0 NobelActive® — 3.5 — NP NobelReplace/ NobelParallel Conical — 4.3, 5.0 — RP 5.5 — WP NobelReplace® Trilobe — 3.5 — NP 4.3 — RP 5.0 — WP 6.0 — 6.0 Nobel Brånemark System® — 3.3 — NP 3.75, 4.0 — RP 5.0 — WP Osstem TS — 3.5 — Mini 4.0, 4.5, 5.0, 6.0, 7.0 — Regular Straumann® BLX — 3.5, 3.75, 4.0, 4.5 — RB 5.0, 5.5, 6.5 — WB Straumann® Bone Level — 3.3 — NC 4.1, 4.8 — RC Straumann® Tissue Level — 3.3 — NNC 3.3, 4.1, 4.8 — RN 4.8 — WN Zimmer Screw-Vent® / Tapered Screw-Vent® — 3.3, 3.7, 4.1 — 3.5 4.7 — 4.5 6.0 — 5.7

Source page: https://510kreport.com/device/K250639
Methodology: https://510kreport.com/methodology