510(k) · Cleared

Cleared

4.0MM Simpler Threaded Dental Implant

K974857510(k) TraditionalCleared Feb 27, 199860-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

Vancouver Implant Resources, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Feb 27, 1998 after a 60-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it.

Decided: Feb 27, 1998
Review: 60 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

1 later device descends from it, 1 citing it directly.

This deviceK974857 4.0MM Simpler Threaded Dental ImplantVancouver Implant Resources, Inc. · 1998
Descendant · cites it directly · 0 of its ownK011574 Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001

Most influential descendants

Showing 1 of 1 · See all

K011574Uniplant Dental Implant SystemUniversal Implant Systems, Inc. · 2001 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K974857	4.0MM Simpler Threaded Dental Implant	Vancouver Implant Resources, Inc.	1998	—
+1	K011574	Uniplant Dental Implant System	Universal Implant Systems, Inc.	2001	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2001	1	0

FIG. 1 — Lineage of K974857, 1998–2001Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

FDA’s file for it is a 510(k) statement, which names no predicate.

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
K011574	Uniplant Dental Implant System	Universal Implant Systems, Inc.	2001	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, K011574 (Universal Implant Systems, Inc., 2001) has gone furthest, with 0 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	—

What is it indicated for?

For use as an intra-bony, supporting component in the oral cavity to support crowns, bridges, and overdentures when replacing missing teeth.

Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974857 · printed Nov 4, 2026

Cite this page

510(k) Report. “K974857: 4.0MM Simpler Threaded Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974857

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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