510(k) · Cleared

Cleared

HexaPLUS S OneDrill Implant System

K243078510(k) TraditionalCleared Oct 10, 2025375-day reviewClass II21 CFR 872.3640

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

Osseofuse International, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Oct 10, 2025 as substantially equivalent to K181157 (Osseofuse International, Inc., 2019) after a 375-day review. Its family tree reaches back 1 generation to 2019.

Decided: Oct 10, 2025
Review: 375 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K181157 (2019). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK181157 Conical Plus Implant SystemOsseofuse International, Inc. · 2019
This deviceK243078 HexaPLUS S OneDrill Implant SystemOsseofuse International, Inc. · 2025

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K181157	Conical Plus Implant System	Osseofuse International, Inc.	2019	—
0 (this device)	K243078	HexaPLUS S OneDrill Implant System	Osseofuse International, Inc.	2025	—

FIG. 1 — Lineage of K243078, 2019–2025Source: 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 DZE? 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 DZE device

#1 K211090 ZENEX Implant Systemscore 25.4 · 15 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
*	K181157	Conical Plus Implant System Summary page 5 …ification regulation: 21 CFR 872.3640 • Product Code: DZE, NHA 4. Predicate Devices: Primary Predicate Device: • Conical Plus Implant System (K181157) by OsseoFuse International, Inc. Reference Devices: • Osseofuse Dental Implant System (K131748) by OsseoFuse In…	Osseofuse International, Inc.	2019	—
†	K131748	Osseofuse Dental Implant System	Osseofuse, Inc.	2013	—
†	K110577	Osseofuse Dental Implant System	Dynamic Innovations, Inc.	2011	—

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?

Its one ancestor has no recall.

How does its category compare?

All DZE devices

DZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007high 265 (2014) · low 107 (2007)2026

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

Recalls per year · DZE

1in 2025

2007high 15 (2016) · low 0 (2011)2026

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

Adverse event reports per year · DZE

465,788in 2025

2007high 537,585 (2023) · low 164 (2009)2025

MAUDE reports naming product code DZE, 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	43	107	11	225
2008	61	118	4	393
2009	41	110	3	164
2010	34	162	3	360
2011	26	194	0	362
2012	39	174	11	358
2013	42	195	1	391
2014	36	265	7	1,124
2015	36	215	3	2,894
2016	40	219	15	1,116
2017	48	223	4	9,719
2018	41	200	4	12,892
2019	31	231	8	167,016
2020	41	230	0	255,524
2021	34	182	6	479,618
2022	34	243	0	483,224
2023	35	248	0	537,585
2024	40	222	1	473,629
2025	31	184	1	465,788
2026	15	194	2	—

What is it indicated for?

The HexaPLUS S OneDrill Implant System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cement-retained, screw-retained, or overdenture restorations, and terminal or intermediate abutment support for fixed bridgework. This system is dedicated for one and two stage surgical procedures. The system is intended for delayed loading.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K243078 · printed Nov 6, 2026

Cite this page

510(k) Report. “K243078: HexaPLUS S OneDrill Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243078

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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