# K170588: DESS Dental Smart Solutions

- Pathway: 510(k) (Traditional)
- Applicant: Terrats Medical SL
- Decided: Aug 8, 2017 after 161 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: 15 generations back to K960026 (1996). 316 ancestors in all.
86 later devices descend from it; 16 cite it directly.
0 of 403 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120414: Osseospeed Plus, Astra Tech AB (2012) Summary page 4.
- K072878: Modification to: Locator Implant Anchor, Zest Anchors, Inc. (2007) Summary page 4.
- K092341: Low Profile Abutments - Internal and External Connection, Biomet 3i, Inc. (2009) Summary page 4.
- K150203: Medentika CAD/CAM Abutments, Medentika GmbH (2015) Summary page 4.
- K150367: Neodent Implant System, Jjgc Industria E Comercio DE Materiais Dentarios S (2015) Summary page 4.
- K063341: 3I Osseotite Certain Dental Implants, Implant Innovations, Inc. (2007) Summary page 5.
- K063286: Osseotite; Osseotite NT; XP; TG Osseotite, Implant Innovations, Inc. (2007) Summary page 5.
- K101732: Astra Tech Implant System, Astra Tech AB (2011) Summary page 5.
- K073075: Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems, Dentsply International, Inc. (2008) Summary page 5.
- K142260: NobelActive, Nobel Biocare AB (2015) Summary page 5.
- K073142: Nobelreplace Hexagonal Implant, Nobel Biocare USA, LLC (2008) Summary page 5.
- K050705: Tiunite Implants, Nobel Biocare AB (2005) Summary page 5.
- K050406: Nobelspeedy Implants, Nobel Biocare AB (2005) Summary page 5.
- K022562: Various Branemark System Implants-Immediate Function Indication, Nobel Biocare AB (2002) Summary page 5.
- K140878: Straumann Bone Level Tapered Implant, Straumann USA, LLC (2014) Summary page 5.
- K062129: P.0004 Implants, Institut Straumann AG (2006) Summary page 5.
- K130222: Straumann Dental Implant System, Straumann USA, LLC (2013) Summary page 5.
- K112160: Tapered Screw-Vent X Implant, Zimmer Dental, Inc. (2011) Summary page 5.

## Most influential descendants
- K173908: DESS Dental Smart Solutions (2018), 51 descendants of its own
- K191986: DESS Dental Smart Solutions (2019), 38 descendants of its own
- K183518: Preat Abutments (2019), 22 descendants of its own
- K212628: DESS Dental Smart Solutions (2022), 20 descendants of its own
- K212577: DESS Dental Smart Solutions (2021), 19 descendants 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 TiBase or Pre-milled Blank are to be sent to a Terrats Medical validated milling center for manufacture. Compatible Implant Systems 3i Certain” — Implant diameter (mm): 3.25, 4.0, 5.0; platform diameter (mm): 34, 4.1, 5.0 3i OSSEOTITE" — Implant diameter (mm): 3.25, 3.75, 4.0, 5.0; platform diameter (mm): 34, 4.1, 5.0 OsseoSpeed ™ — Implant diameter (mm): 3.5, 4.0, 5.0; platform diameter (mm): 3.5/4.0, 4.5/5.0 FRIADENT XiVE — Implant diameter (mm): 34, 38, 4.5; platform diameter (mm): 34, 3.8, 4.5 NobelActive®” — Implant diameter (mm): 3.5, 4.3, 5.0; platform diameter (mm): NP, RP NobelReplace Conical — Implant diameter (mm): 3.5, 43, 5.0; platform diameter (mm): NP, RP Nobel Replace Trilobe — Implant diameter (mm): 3.5, 43, 5.0; platform diameter (mm): NP, RP, WP Branemark — Implant diameter (mm): 3.5, 3.75/4.0, 5.0; platform diameter (mm): NP, RP, WP Straumann” Bone Level — Implant diameter (mm): 3.3, 4.1, 4.8; platform diameter (mm): NC, RC Straumann” Tissue Level — Implant diameter (mm): 3.3, 4.1, 4.8; platform diameter (mm): RN, WN Tapered Screw-Vent” — Implant diameter (mm): 3.7, 4.1, 4.7, 6.0; platform diameter (mm): 3.5, 4.5, 5.7

Source page: https://510kreport.com/device/K170588
Methodology: https://510kreport.com/methodology