510(k) · Cleared

Cleared

BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated, 3.308, 3.310,3.312, 3.314 3.316

K010343510(k) TraditionalCleared Feb 14, 20019-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

Buck Medical Research · DZE Implant, Endosseous, Root-Form

Cleared on Feb 14, 2001 after a 9-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it.

Decided: Feb 14, 2001
Review: 9 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

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

This deviceK010343 BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated…Buck Medical Research · 2001
Descendant · cites it directly · 0 of its ownK031322 Intra-Lock Hydroxyapatite Coated ImplantsIntra-Lock International · 2003

Most influential descendants

Showing 1 of 1 · See all

K031322Intra-Lock Hydroxyapatite Coated ImplantsIntra-Lock International · 2003 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K010343	BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated, 3.308…	Buck Medical Research	2001	—
+1	K031322	Intra-Lock Hydroxyapatite Coated Implants	Intra-Lock International	2003	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

FIG. 1 — Lineage of K010343, 2001–2003Source: 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? (1)

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

Number	Device	Applicant	Decided	Descendants
K031322	Intra-Lock Hydroxyapatite Coated Implants	Intra-Lock International	2003	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, K031322 (Intra-Lock International, 2003) 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	—

https://510kreport.com/device/K010343 · printed Nov 6, 2026

Cite this page

510(k) Report. “K010343: BMR Dental Implant System, Model 3.3XX, Either HA or TPS Coated, 3.308, 3.310,3.312, 3.314 3.316.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K010343

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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