# K253804: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Apr 16, 2026 after 139 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: 22 generations back to K960026 (1996). 329 ancestors in all.
No later device cites it as a predicate yet.
0 of 330 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251547: DESS Dental Smart Solutions, Terrats Medical SL (2025) 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. 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 Astra Tech EV — 3.6 — 3.6 Astra Tech EV — 4.2 — 4.2 Astra Tech EV — 4.8 — 4.8 Astra Tech EV — 5.4 — 5.4 Astra Tech OsseoSpeedTM — 3.0 — 3.0 Astra Tech OsseoSpeedTM — 3.5/4.0 — 3.5/4.0 Astra Tech OsseoSpeedTM — 4.5/5.0 — 4.5/5.0 BioHorizons Internal — 3.0, 3.4, 3.8 — 3.0 BioHorizons Internal — 3.8, 4.6 — 3.5 BioHorizons Internal — 4.6, 5.8 — 4.5 BioHorizons Internal — 5.8 — 5.7 Biomet 3i Certain® — 3.25 — 3.4 Biomet 3i Certain® — 4.0 — 4.1 Biomet 3i Certain® — 5.0 — 5.0 Biomet 3i OSSEOTITE® — 3.25 — 3.4 Biomet 3i OSSEOTITE® — 3.75, 4.0 — 4.1 Biomet 3i OSSEOTITE® — 5.0 — 5.0 Keystone Prima Connex — 3.3, 3.5 — 3.5 Keystone Prima Connex — 4.0, 4.1 — 4.1 Keystone Prima Connex — 5.0 — 5.0 MegaGen AnyRidge — 3.5, 4.0, 4.5, 5.0, 5.5 — 3.5 MIS C1 — 3.30 — NP MIS C1 — 3.75, 4.20 — SP Neodent Grand Morse — 3.5, 3.75, 4.0, 4.3, 5.0, 6.0, 7.0 — Grand Morse (GM) NobelActive® — 3.5 — NP (3.5) NobelActive® — 4.3, 5.0 — RP (3.9) NobelReplace/ NobelParallel Conical — 5.5 — WP (5.1) NobelReplace® Trilobe — 3.5 — NP (3.5) NobelReplace® Trilobe — 4.3 — RP (4.3) NobelReplace® Trilobe — 5.0 — WP Nobel Brånemark System® — 3.3 — NP Nobel Brånemark System® — 3.75, 4.0 — RP Nobel Brånemark System® — 5.0 — WP Straumann® BLX — 3.5, 3.75, 4.0, 4.5 — RB Straumann® BLX — 5.0, 5.5, 6.5 — WB Straumann® Bone Level — 3.3 — NC Straumann® Bone Level — 4.1, 4.8 — RC Zimmer Screw-Vent® / Tapered Screw-Vent® — 3.7, 4.1 — 3.5 Zimmer Screw-Vent® / Tapered Screw-Vent® — 4.7 — 4.5 Zimmer Screw-Vent® / Tapered Screw-Vent® — 6.0 — 5.7

Source page: https://510kreport.com/device/K253804
Methodology: https://510kreport.com/methodology