510(k) · Cleared

Cleared

DESS Dental Smart Solutions

K233316510(k) TraditionalCleared Jan 5, 202498-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Terrats Medical SL · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jan 5, 2024 as substantially equivalent to K170588 (Terrats Medical SL, 2017) after a 98-day review. Its family tree reaches back 16 generations to 1996. 8 later devices descend from it.

Decided: Jan 5, 2024
Review: 98 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 16 generations to K960026 (1996). 317 ancestors in all, the oldest K781060 (1978). 8 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
12 generations between
3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
This deviceK233316 DESS Dental Smart SolutionsTerrats Medical SL · 2024
Descendant · cites it directly · 7 of its ownK240208 DESS Dental Smart SolutionsTerrats Medical SL · 2024
Descendant · 2 generations on · 3 of its ownK242340 DESS Dental Smart SolutionsTerrats Medical SL · 2024
Descendant · 2 generations on · 1 of its ownK251547 DESS Dental Smart SolutionsTerrats Medical SL · 2025
Descendant · 2 generations on · 0 of its ownK254145 Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026
Descendant · 2 generations on · 0 of its ownK260564 DESS Dental Smart SolutionsTerrats Medical SL · 2026

Show all 16 generations

Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
7 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
6 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
5 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
4 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
2 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
This deviceK233316 DESS Dental Smart SolutionsTerrats Medical SL · 2024

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2024high 3 (2025) · low 2 (2024)2026

Most influential descendants

Showing 5 of 8 · See all

K240208DESS Dental Smart SolutionsTerrats Medical SL · 2024 · cites it directly7descendants
K242340DESS Dental Smart SolutionsTerrats Medical SL · 2024 · 2 generations on3descendants
K251547DESS Dental Smart SolutionsTerrats Medical SL · 2025 · 2 generations on1descendant
K254145Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)Smart Denture Conversions, LLC · 2026 · 2 generations on0descendants
K260564DESS Dental Smart SolutionsTerrats Medical SL · 2026 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−16	K960026	Biohorizons Dental Implant System	BioHorizons Implant Systems, Inc.	1996	—
−15	K964330	Biohorizons Dental Implant System (Name Subject to Change)	BioHorizons Implant Systems, Inc.	1997	—
−14	K972313	The Maestro System	BioHorizons Implant Systems, Inc.	1997	—
−13	K020133	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−12	K020645	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−11	K022795	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2002	—
−10	K030463	Modification to the Maestro System	BioHorizons Implant Systems, Inc.	2003	1
−9	K032351	The Maestro System 3.0MM Diameter Implant	BioHorizons Implant Systems, Inc.	2003	—
−8	K041938	Maximus OS (Overdenture System)	BioHorizons Implant Systems, Inc.	2004	2
−7	K063364	Alpha Bio Dental Implant System	Alpha-Bio Tec, Ltd.	2007	—
−6	K081653	Mdi Mii One-Piece Implant, 2.9MM	Imtec Corp.	2008	1
−5	K123022	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2013	—
−4	K133510	Neodent Implant System	Jj Industria E Comercio DE Materiais Dentarios SA	2014	—
−3	K133592	Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…	Neodent USA, Inc.	2014	—
−2	K150367	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2015	—
−1	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—
0 (this device)	K233316	DESS Dental Smart Solutions	Terrats Medical SL	2024	—
+1	K240208	DESS Dental Smart Solutions	Terrats Medical SL	2024	—
+2	K242340	DESS Dental Smart Solutions	Terrats Medical SL	2024	—
+2	K251547	DESS Dental Smart Solutions	Terrats Medical SL	2025	—
+2	K254145	Omni-Directional Multi-Unit Abutment System (Trade Name: Omnibut™)	Smart Denture Conversions, LLC	2026	—
+2	K260564	DESS Dental Smart Solutions	Terrats Medical SL	2026	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1978	1	0
1982	1	0
1985	1	0
1986	2	0
1987	2	0
1988	1	0
1989	5	0
1990	7	0
1991	1	0
1992	4	0
1993	12	0
1994	12	0
1995	15	0
1996	16	0
1997	7	0
1998	8	0
1999	11	0
2000	11	0
2001	18	0
2002	19	0
2003	17	0
2004	16	0
2005	14	0
2006	17	0
2007	23	0
2008	14	0
2009	13	0
2010	10	0
2011	10	0
2012	5	0
2013	3	0
2014	3	0
2015	2	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2024	2	0
2025	3	0
2026	3	0

FIG. 1 — Lineage of K233316, 1996–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in NHA? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new NHA device

#1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

Get a 510(k) Report

What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K170588	DESS Dental Smart Solutions Summary page 6 …iratory, ENT and Dental Devices) Reviewing Division Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K191986, DESS Dental Smart Solutions, Terrats Medical SL K212…	Terrats Medical SL	2017	—
†	K191986	DESS Dental Smart Solutions	Terrats Medical SL	2019	—
†	K212628	DESS Dental Smart Solutions	Terrats Medical SL	2022	—
†	K222288	DESS Dental Smart Solutions	Terrats Medical SL	2022	—
†	K212538	DESS Dental Implants	Terrats Medical SL	2021	—
†	K231434	DESS Dental Smart Solutions	Terrats Medical SL	2023	—
†	K140347	Ankylos C/X Implant System	Dentsply Intl., Inc.	2014	—
†	K120414	Osseospeed Plus	Astra Tech AB	2012	—
†	K111287	Astra Tech Implant System	Astra Tech AB	2011	—
†	K101732	Astra Tech Implant System	Astra Tech AB	2011	—
†	K042429	The Prodigy System Dental Implants	BioHorizons Implant Systems, Inc.	2004	—
†	K071638	Biohorizons Tapered Internal Implant System	BioHorizons Implant Systems, Inc.	2007	2
†	K093321	Biohorizons Laser-Lok 3.0 Implant System	BioHorizons Implant Systems, Inc.	2010	1
†	K063341	3I Osseotite Certain Dental Implants	Implant Innovations, Inc.	2007	10
†	K083496	Camlog Implant System Modified Implants and Abutments	Altatec GmbH	2009	—
†	K160965	SuperLine	Dentium Co., Ltd.	2017	—
†	K073075	Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems	Dentsply International, Inc.	2008	—
†	K163194	Neodent Implant System - GM Line	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2017	6
†	K180536	Neodent Implant System – GM Line	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2018	—
†	K201225	Neodent Implant System - GM Helix Implants 7.0	Jjgc Industria E Comercio DE Materiais Dentarios S.A.	2020	—
†	K142260	NobelActive	Nobel Biocare AB	2015	—
†	K173418	NobelParallel Conical Connection	Nobel Biocare AB	2019	1
†	K050705	Tiunite Implants	Nobel Biocare AB	2005	1
†	K050406	Nobelspeedy Implants	Nobel Biocare AB	2005	—
†	K050258	Groovy Implants	Nobel Biocare AB	2005	28
†	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	27
†	K161604	OSSTEM Implant System	Osstem Implant Co., Ltd.	2016	—
†	K173961	Straumann BLX Implant System	Institut Straumann AG	2018	—
†	K181703	Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments	Institut Straumann AG	2018	—
†	K191256	Straumann BLX Ø3.5 mm Implants	Institut Straumann AG	2019	—
†	K210855	Straumann BLX Implant System	Institut Straumann AG	2021	—
†	K212533	BLX WB Ø5.0 (L18), Ø5.5 and Ø6.5 mm (L14 and L16) Implants	Institut Straumann AG	2022	—
†	K140878	Straumann Bone Level Tapered Implant	Straumann USA, LLC	2014	2
†	K130222	Straumann Dental Implant System	Straumann USA, LLC	2013	—
†	K013227	Screw Vent Implant; Tapered Screw Vent Implant	Sulzer Dental, Inc.	2001	2
†	K072589	Tapered Screw-Vent Implant, 4.1MM, Models: TSV4B8, B10, B11, B13 and B16, TSV4H8, H11…	Zimmer Dental, Inc.	2007	3
†	K220978	TSX Implants	Biomet 3i, LLC	2022	—

Also cleared against K170588: 15 other devices →

What descends from it? (8)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K240208	DESS Dental Smart Solutions	Terrats Medical SL	2024	7

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 28 years and passes through 7 companies; a new generation was cleared every 10 months on median.
43 of the 317 ancestors have a recall of any class.
Of its descendants, K240208 (Terrats Medical SL, 2024) has gone furthest, with 7 descendants of its own.
15 other devices also cite its predicate K170588.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · NHA

1in 2025

2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	38	91	1	1
2008	31	90	2	8
2009	30	95	0	30
2010	19	162	0	61
2011	31	130	5	56
2012	25	171	1	5
2013	22	184	1	143
2014	27	160	0	146
2015	29	151	1	858
2016	38	202	36	314
2017	31	188	2	577
2018	31	200	1	591
2019	28	160	0	530
2020	38	153	7	458
2021	29	211	0	546
2022	33	142	0	497
2023	51	147	3	618
2024	43	158	0	635
2025	40	147	1	838
2026	23	169	3	—

What is it indicated for?

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.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K233316 · printed Nov 5, 2026

Cite this page

510(k) Report. “K233316: DESS Dental Smart Solutions.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233316

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026