510(k) · Cleared

Cleared

KJ Submerged System

K103810510(k) TraditionalCleared Sep 14, 2011259-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

Kj Meditech Co., Ltd. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 14, 2011 as substantially equivalent to K101849 (Bicon, LLC, 2010) and 8 other predicates after a 259-day review. Its family tree reaches back 1 generation to 1997. 1 later device descends from it.

Decided: Sep 14, 2011
Review: 259 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 9

Its longest line of descent runs back 1 generation to K972417 (1997). 9 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK972417 The 6.0 X 8.0MM Dental Implant SystemBicon, Inc. · 1997
This deviceK103810 KJ Submerged SystemKj Meditech Co., Ltd. · 2011
Descendant · cites it directly · 0 of its ownK202046 LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. · 2022

Most influential descendants

Showing 1 of 1 · See all

K202046LOTA SLA Dental Implant System and LOTA HA Dental Implant SystemKj Meditech Co., Ltd. · 2022 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K972417	The 6.0 X 8.0MM Dental Implant System	Bicon, Inc.	1997	—
0 (this device)	K103810	KJ Submerged System	Kj Meditech Co., Ltd.	2011	—
+1	K202046	LOTA SLA Dental Implant System and LOTA HA Dental Implant System	Kj Meditech Co., Ltd.	2022	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2000	1	0
2002	1	0
2004	1	0
2005	1	0
2006	1	0
2008	1	0
2009	1	0
2010	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2022	1	0

FIG. 1 — Lineage of K103810, 1997–2022Source: 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? (9)

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
*	K101849	Bicon Dental Implant System 3.0MM Bicon Dental Implant Summary page 2 …ensure the devices comply with the applicable International and US regulations. K101 849 K092035…	Bicon, LLC	2010	—
*	K092035	Bicon Implants with a 2.5MM Internal Connection Summary page 1 …plant System Product Code: DZE Classification regulation: 21 CFRS72.3640 2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description:…	Bicon, LLC	2009	—
*	K073368	5.0 X 5.0MM Dental Implant and 6.0 X 5.0 Dental Implant Summary page 1 …tem Product Code: DZE Classification regulation: 21 CFRS72.3640 2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The K…	Bicon, LLC	2008	—
*	K062044	The 5.0 X 6.0MM Dental Implant Summary page 1 …Product Code: DZE Classification regulation: 21 CFRS72.3640 2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The KJ Submerg…	Bicon, Inc.	2006	—
*	K050712	4.5.* 6.0MM Dental Implant and 6.0*6.0 MM Dental Implant Summary page 1 …gulation: 21 CFRS72.3640 2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The KJ Submerged System replaces the root of a missing tooth…	Bicon, Inc.	2005	—
*	K042637	The 5.0 X 6.0MM Dental Implant Summary page 1 …21 CFRS72.3640 2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The KJ Submerged System replaces the root of a missing tooth and is m…	Bicon, Inc.	2004	—
*	K010185	6.0 X 5.7MM Dental Implant Summary page 2 …K050712 K042637 K010185 K994037…	Bicon, Inc.	2002	—
*	K994037	The 4.5MM Diameter Bicon Dental Implant Summary page 1 …2. Predicate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The KJ Submerged System replaces the root of a missing tooth and is made from 510(k) Sub…	Bicon, Inc.	2000	—
*	K972417	The 6.0 X 8.0MM Dental Implant System Summary page 1 …cate Device: Bicon Implant System by Bicon LLC. (KIO 1849, K092035, K073368, K062044, K050712, K042637, KO010 185, K994037, K972417) 3. Description: The KJ Submerged System replaces the root of a missing tooth and is made from 510(k) Submission.…	Bicon, Inc.	1997	—

Also cleared against K101849: 5 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K202046	LOTA SLA Dental Implant System and LOTA HA Dental Implant System	Kj Meditech Co., Ltd.	2022	0

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?

None of the 9 ancestors has a recall.
Of its descendants, K202046 (Kj Meditech Co., Ltd., 2022) has gone furthest, with 0 descendants of its own.
5 other devices also cite its predicate K101849.

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. 2011, 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 KJ Submerged System is indicated for use in partially or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations including; cemented 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 and not dedicated for immediate loading.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K103810 · printed Nov 6, 2026

Cite this page

510(k) Report. “K103810: KJ Submerged System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K103810

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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