510(k) · Cleared

Cleared

Inplant Orthodontic Anchor System

K000643510(k) TraditionalCleared Sep 7, 2000195-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

Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Sep 7, 2000 after a 195-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 64 later devices descend from it.

Decided: Sep 7, 2000
Review: 195 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

64 later devices descend from it, 6 citing it directly.

This deviceK000643 Inplant Orthodontic Anchor SystemNobel Biocare Uas, Inc. · 2000
Descendant · cites it directly · 63 of its ownK031936 Osteomed Orthodontic Screw SystemOsteomed LP · 2004
Descendant · cites it directly · 54 of its ownK033767 Dual Top Anchor System ScrewsJeil Medical Corporation · 2004
Descendant · cites it directly · 26 of its ownK042965 Tomas PinDentaurum, Inc. · 2005
Descendant · 2 generations on · 19 of its ownK060126 Absoanchor MicroimplantDentos, Inc. · 2006
Descendant · 3 generations on · 14 of its ownK071490 Leone Orthodontic Mini ImplantLeone S.P.A. · 2008

Showing 5 of 64 descendants. See all descendants

Descendants cleared per year

2004high 8 (2006) · low 0 (2014)2026

Most influential descendants

Showing 5 of 64 · See all

K031936Osteomed Orthodontic Screw SystemOsteomed LP · 2004 · cites it directly63descendants
K033767Dual Top Anchor System ScrewsJeil Medical Corporation · 2004 · cites it directly54descendants
K042965Tomas PinDentaurum, Inc. · 2005 · cites it directly26descendants
K060126Absoanchor MicroimplantDentos, Inc. · 2006 · 2 generations on19descendants
K071490Leone Orthodontic Mini ImplantLeone S.P.A. · 2008 · 3 generations on14descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000643	Inplant Orthodontic Anchor System	Nobel Biocare Uas, Inc.	2000	—
+1	K031936	Osteomed Orthodontic Screw System	Osteomed LP	2004	—
+1	K033767	Dual Top Anchor System Screws	Jeil Medical Corporation	2004	—
+1	K042965	Tomas Pin	Dentaurum, Inc.	2005	—
+2	K060126	Absoanchor Microimplant	Dentos, Inc.	2006	—
+3	K071490	Leone Orthodontic Mini Implant	Leone S.P.A.	2008	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	2	0
2005	5	0
2006	8	0
2007	3	0
2008	6	0
2009	3	0
2010	2	0
2011	5	0
2012	2	0
2013	2	0
2015	2	0
2016	2	0
2017	2	0
2018	1	0
2019	4	0
2020	4	0
2021	4	0
2022	1	0
2023	1	0
2024	2	0
2025	2	0
2026	1	0

FIG. 1 — Lineage of K000643, 2000–2026Source: 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? (64)

See all 64

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

Number	Device	Applicant	Decided	Descendants
K031936	Osteomed Orthodontic Screw System	Osteomed LP	2004	63
K033767	Dual Top Anchor System Screws	Jeil Medical Corporation	2004	54
K042965	Tomas Pin	Dentaurum, Inc.	2005	26
K062733	Tomas Pin SD 6, 8, and 10 MM	Dentaurum	2006	6
K062367	Miniscrews Anchoring System, M.a.S.	Micerium S.P.A.	2006	1
K053629	Anchor Plus/Neo Anchor Plus	Kj Meditech	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, K031936 (Osteomed LP, 2004) has gone furthest, with 63 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/K000643 · printed Nov 3, 2026

Cite this page

510(k) Report. “K000643: Inplant Orthodontic Anchor System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K000643

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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