510(k) · Cleared

Cleared

The Lifecore Stage-1 Single Stage RBM Dental Implant System

K003226510(k) TraditionalCleared Jan 12, 200188-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

Lifecore Biomedical, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jan 12, 2001 after an 88-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 400 later devices descend from it.

Decided: Jan 12, 2001
Review: 88 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

400 later devices descend from it, 5 citing it directly.

This deviceK003226 The Lifecore Stage-1 Single Stage RBM Dental Implant SystemLifecore Biomedical, Inc. · 2001
Descendant · cites it directly · 222 of its ownK051576 Avana Dental Implant SystemOsstem Co., Ltd. · 2005
Descendant · 2 generations on · 211 of its ownK062051 SS SystemOsstem Implant Co., Ltd. · 2006
Descendant · 3 generations on · 202 of its ownK063861 GS SystemOsstem Implant Co., Ltd. · 2007
Descendant · 2 generations on · 183 of its ownK062030 US SystemOsstem Implant Co., Ltd. · 2006
Descendant · cites it directly · 180 of its ownK101945 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011

Showing 5 of 400 descendants. See all descendants

Descendants cleared per year

2002high 48 (2023) · low 0 (2003)2026

Most influential descendants

Showing 5 of 400 · See all

K051576Avana Dental Implant SystemOsstem Co., Ltd. · 2005 · cites it directly222descendants
K062051SS SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on211descendants
K063861GS SystemOsstem Implant Co., Ltd. · 2007 · 3 generations on202descendants
K062030US SystemOsstem Implant Co., Ltd. · 2006 · 2 generations on183descendants
K101945Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2011 · cites it directly180descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K003226	The Lifecore Stage-1 Single Stage RBM Dental Implant System	Lifecore Biomedical, Inc.	2001	—
+1	K051576	Avana Dental Implant System	Osstem Co., Ltd.	2005	—
+2	K062051	SS System	Osstem Implant Co., Ltd.	2006	—
+3	K063861	GS System	Osstem Implant Co., Ltd.	2007	—
+2	K062030	US System	Osstem Implant Co., Ltd.	2006	—
+1	K101945	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2005	1	0
2006	3	0
2007	3	0
2008	10	0
2009	9	0
2010	6	0
2011	8	0
2012	9	0
2013	15	0
2014	16	0
2015	11	0
2016	14	0
2017	19	0
2018	18	0
2019	15	0
2020	38	0
2021	30	0
2022	32	0
2023	48	0
2024	38	0
2025	33	0
2026	23	0

FIG. 1 — Lineage of K003226, 2001–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), 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?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (400)

See all 400

5 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K051576	Avana Dental Implant System	Osstem Co., Ltd.	2005	222
K101945	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2011	180
K021322	Endossous Implants	Intra-Lock International	2002	6
K072768	Restore, Stage-1, Renova Primasolo and Primaconnex Dental Implants	Lifecore Biomedical, Inc.	2007	0
K053643	Stage- 1 Temporary/Healing Cap, Model 42021-42026	Lifecore Biomedical, Inc.	2006	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?

Of its descendants, K051576 (Osstem Co., Ltd., 2005) has gone furthest, with 222 descendants of its own.

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.

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	—

https://510kreport.com/device/K003226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K003226: The Lifecore Stage-1 Single Stage RBM Dental 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/K003226

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Record history

FDA decision record loaded May 2, 2026
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026