# K260564: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Jun 9, 2026 after 110 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: 20 generations back to K960026 (1996). 326 ancestors in all.
No later device cites it as a predicate yet.
0 of 327 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K170588: DESS Dental Smart Solutions, Terrats Medical SL (2017) Summary page 6.
- K222269: DESS Dental Smart Solutions, Terrats Medical SL (2022) Summary page 6.
- K240208: DESS Dental Smart Solutions, Terrats Medical SL (2024) Summary page 7.
- K120954: Nobelprocera Peek Abutments, Nobel Biocare AB (2013) Summary page 7.

## 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. The PEEK Abutments are premanufactured prosthetic component directly connected to the endosseous dental implants and are intended for provisional use up to 180 days as an aid in prosthetic rehabilitation. Compatible Implant Systems Implant Compatibility (Connection) Implant Body Diameter, mm Implant Platform, mm NobelActive® NobelReplace/NobelParallel Conical 3.0 3.0 3.5 NP (3.5) 4.3, 5.0 RP (3.9) 5.5 WP (5.1) NobelReplace® Trilobe 3.5 NP (3.5) 4.3 RP (4.3) 5.0 WP Nobel Brånemark System® 3.3 NP 3.75, 4.0 RP 5.0 WP Keystone Paltop Dynamic (Internal Hex) 3.0, 3.25 NP (3.25) PALTOP ADVANCED CLASSIC (Internal Hex) 3.25 NP (3.25) PALTOP ADVANCED PLUS (Internal Hex) 3.0, 3.25 NP (3.25) Keystone Paltop Dynamic Conical (Internal conical) 3.25, 3.75, 4.2, 5.0 CC (3.25/3.75/4.2/5.0) Genesis Active (Internal conical) 3.5, 3.8, 4.5, 5.5 CC (3.5/3.8/4.5/5.5) PALTOP Implants (Internal conical) 3.25 NP (3.25) Keystone Prima Plus Conical (Internal conical) 3.5, 4.1, 5.0, 6.0 CC (3.5, 4.1, 5.0, 6.0)

Source page: https://510kreport.com/device/K260564
Methodology: https://510kreport.com/methodology