510(k) · Cleared

Cleared

Branemark Novum

K000018510(k) TraditionalCleared Mar 30, 200086-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 Mar 30, 2000 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 263 later devices descend from it.

Decided: Mar 30, 2000
Review: 86 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

263 later devices descend from it, 2 citing it directly.

This deviceK000018 Branemark NovumNobel Biocare Uas, Inc. · 2000
Descendant · cites it directly · 259 of its ownK030685 Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004 · Recalled
Descendant · 2 generations on · 258 of its ownK050393 The Guided Surgery ConceptNobel Biocare AB · 2005
Descendant · 2 generations on · 248 of its ownK053602 Procera Software, Model 33145Nobel Biocare AB · 2006
Descendant · 3 generations on · 242 of its ownK062493 Lava Software3M Espe AG Dental Products · 2006
Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010

Showing 5 of 263 descendants. See all descendants

Descendants cleared per year

2004high 34 (2024) · low 0 (2007)2026

Most influential descendants

Showing 5 of 263 · See all

K030685Teeth in an Hour - Ark Implant ConceptNobel Biocare AB · 2004 · cites it directly259descendants
K050393The Guided Surgery ConceptNobel Biocare AB · 2005 · 2 generations on258descendants
K053602Procera Software, Model 33145Nobel Biocare AB · 2006 · 2 generations on248descendants
K062493Lava Software3M Espe AG Dental Products · 2006 · 3 generations on242descendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K000018	Branemark Novum	Nobel Biocare Uas, Inc.	2000	—
+1	K030685	Teeth in an Hour - Ark Implant Concept	Nobel Biocare AB	2004	1
+2	K050393	The Guided Surgery Concept	Nobel Biocare AB	2005	—
+2	K053602	Procera Software, Model 33145	Nobel Biocare AB	2006	—
+3	K062493	Lava Software	3M Espe AG Dental Products	2006	—
+4	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	1	0
2005	1	0
2006	2	0
2009	1	0
2010	2	0
2011	3	0
2012	5	0
2013	4	0
2014	7	0
2015	11	0
2016	14	0
2017	15	0
2018	13	0
2019	14	0
2020	21	0
2021	22	0
2022	19	0
2023	32	0
2024	34	0
2025	28	0
2026	14	0

FIG. 1 — Lineage of K000018, 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? (263)

See all 263

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

Number	Device	Applicant	Decided	Descendants
K030685	Teeth in an Hour - Ark Implant Concept	Nobel Biocare AB	2004	259
K152836	TREFOIL System	Nobel Biocare AB	2016	2

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, K030685 (Nobel Biocare AB, 2004) has gone furthest, with 259 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/K000018 · printed Nov 4, 2026

Cite this page

510(k) Report. “K000018: Branemark Novum.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K000018

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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