510(k) · Cleared

Cleared

Implant-One System

K231455510(k) TraditionalCleared Aug 15, 202389-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

Implant Logistics, Inc. · NHA Abutment, Implant, Dental, Endosseous

Cleared on Aug 15, 2023 as substantially equivalent to K180899 (Nobel Biocare AB, 2018) after an 89-day review. Its family tree reaches back 3 generations to 1994.

Decided: Aug 15, 2023
Review: 89 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 3 generations to K913255 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK913255 Ceramic (TM) AbutmentCeramic Core Corp. · 1994
2 generations backK031719 Esthetic Zirconia AbutmentNobel Biocare AB · 2003
1 generation backK180899 Universal Base AbutmentNobel Biocare AB · 2018
This deviceK231455 Implant-One SystemImplant Logistics, Inc. · 2023

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K913255	Ceramic (TM) Abutment	Ceramic Core Corp.	1994	—
−2	K031719	Esthetic Zirconia Abutment	Nobel Biocare AB	2003	—
−1	K180899	Universal Base Abutment	Nobel Biocare AB	2018	—
0 (this device)	K231455	Implant-One System	Implant Logistics, Inc.	2023	—

FIG. 1 — Lineage of K231455, 1994–2023Source: 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

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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
*	K180899	Universal Base Abutment Summary page 4 …s, Office of Product Evaluation and Quality Reviewing Division DHT1B: Division of Dental and ENT Devices PREDICATE DEVICE INFORMATION Primary Predicate Device K180899, NobelActive™ Universal Base Abutments, Nobel Biocare USA LLC 510(k) Summary…	Nobel Biocare AB	2018	—
†	K212394	Implant-One Multi-Unit Abutment	Implant Logistics, Inc.	2023	—
†	K102822	Implant-One System	Custom Dental Implants, Inc.	2011	—
†	K173701	Implant-One System	Implant Logistics, Inc.	2018	—

Also cleared against K180899: 2 other devices →

What descends from it?

No later submission names this one as a predicate yet.

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 29 years and passes through 3 companies; a new generation was cleared every 8.9 years on median.
None of the 3 ancestors has a recall.
2 other devices also cite its predicate K180899.

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. 2023, 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?

Implant-One™ System Abutments are intended for use as an aid in prosthetic rehabilitation in the mandible or maxilla for support of single-unit or multi-unit restorations.

The Implant-One Ti-Base Abutment consists of the titanium base and a mesostructure component, making up a two-piece abutment, and will be attached to the implant using an abutment screw. The mesostructure for use with the Implant-One Ti-Base is intended only to be designed and manufactured according to digital dentistry workflow that integrates scan files from lab scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K231455 · printed Nov 6, 2026

Cite this page

510(k) Report. “K231455: Implant-One System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K231455

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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