510(k) · Cleared

Cleared

Lifecore Single Tooth Abutment System

K993894510(k) TraditionalCleared Mar 8, 2000113-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 Mar 8, 2000 as substantially equivalent to K965077 (Implant Innovations, Inc., 1997) and 1 other predicate after a 113-day review. Its family tree reaches back 1 generation to 1991.

Decided: Mar 8, 2000
Review: 113 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K910611 (1991). 2 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK910611 Nobelpharma Ceraone Abutment SystemNobelpharma USA, Inc. · 1991
This deviceK993894 Lifecore Single Tooth Abutment SystemLifecore Biomedical, Inc. · 2000

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K910611	Nobelpharma Ceraone Abutment System	Nobelpharma USA, Inc.	1991	—
0 (this device)	K993894	Lifecore Single Tooth Abutment System	Lifecore Biomedical, Inc.	2000	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0

FIG. 1 — Lineage of K993894, 1991–2000Source: 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? (2)

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
*	K965077	Single Toot Abutment System (Sta or ST Abutment ) for Single Ooth Cement Retained… Summary page 1 …tion Name \| Precision Attachment for use as an accessory for Class lll Endosseous Implants (per 21 CFR 872.3165) Identification of Single Tooth Abutment System (STA™) (K965077), Equivalent Devices \| manufactured by Implant Innovations, and CeraOne® Abutment System (K910611), manufactured by Nobel Bioc…	Implant Innovations, Inc.	1997	—
*	K910611	Nobelpharma Ceraone Abutment System Summary page 1 …CFR 872.3165) Identification of Single Tooth Abutment System (STA™) (K965077), Equivalent Devices \| manufactured by Implant Innovations, and CeraOne® Abutment System (K910611), manufactured by Nobel Biocare 3. Device Description The Lifecore Single Tooth Abutment System is designed for use with an en…	Nobelpharma USA, Inc.	1991	—

Also cleared against K965077: 3 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?

None of the 2 ancestors has a recall.
3 other devices also cite its predicate K965077.

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	—

What is it indicated for?

The Lifecore Single Tooth Abutment is intended to attach to an endosseous implant and provide support and retention for a single-tooth restoration in the mandible or maxilla.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K993894 · printed Nov 5, 2026

Cite this page

510(k) Report. “K993894: Lifecore Single Tooth Abutment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K993894

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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