510(k) · Cleared

Cleared

Nobeldirect OD Implant

K041876510(k) TraditionalCleared Aug 20, 200439-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 Aug 20, 2004 as substantially equivalent to K022562 (Nobel Biocare AB, 2002) and 1 other predicate after a 39-day review. Its family tree reaches back 1 generation to 2002. 188 later devices descend from it.

Decided: Aug 20, 2004
Review: 39 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 2

Its longest line of descent runs back 1 generation to K022562 (2002). 2 ancestors in all. 188 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 1 generation backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
This deviceK041876 Nobeldirect OD ImplantNobel Biocare Uas, Inc. · 2004
Descendant · cites it directly · 187 of its ownK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
Descendant · 2 generations on · 141 of its ownK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
Descendant · 3 generations on · 127 of its ownK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
Descendant · 4 generations on · 123 of its ownK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
Descendant · 4 generations on · 109 of its ownK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014

Showing 5 of 188 descendants. See all descendants

Descendants cleared per year

2007high 24 (2025) · low 0 (2009)2026

Most influential descendants

Showing 5 of 188 · See all

K063364Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007 · cites it directly187descendants
K081653Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · 2 generations on141descendants
K123022Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013 · 3 generations on127descendants
K133510Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014 · 4 generations on123descendants
K133592Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart EX Acqua…Neodent USA, Inc. · 2014 · 4 generations on109descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K022562	Various Branemark System Implants-Immediate Function Indication	Nobel Biocare AB	2002	—
0 (this device)	K041876	Nobeldirect OD Implant	Nobel Biocare Uas, Inc.	2004	—
+1	K063364	Alpha Bio Dental Implant System	Alpha-Bio Tec, Ltd.	2007	—
+2	K081653	Mdi Mii One-Piece Implant, 2.9MM	Imtec Corp.	2008	1
+3	K123022	Neodent Implant System	Jjgc Industria E Comercio DE Materiais Dentarios S	2013	—
+4	K133510	Neodent Implant System	Jj Industria E Comercio DE Materiais Dentarios SA	2014	—
+4	K133592	Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart…	Neodent USA, Inc.	2014	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	2	0
2010	1	0
2011	1	0
2012	5	0
2013	5	0
2014	9	0
2015	7	0
2016	5	0
2017	5	0
2018	8	0
2019	13	0
2020	16	0
2021	14	0
2022	20	0
2023	18	0
2024	20	0
2025	24	0
2026	14	0

FIG. 1 — Lineage of K041876, 2002–2026Source: 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

Get a 510(k) Report

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
*	K022562	Various Branemark System Implants-Immediate Function Indication Summary page 1 …872.3640) Trade or Proprietary or Model Name: Nobeloirectmt 00 Implant Legally Marketed Device(s): Br~nemark System Implants (K022562) Replace One-Piece Implants (K023952) DeviceDscitin Nobel Biocare's NobeloirectTM 00…	Nobel Biocare AB	2002	—
*	K023952	Replace One Piece Implant, HA, Replace One Piece Implant, Tiunite Summary page 1 …loirectmt 00 Implant Legally Marketed Device(s): Br~nemark System Implants (K022562) Replace One-Piece Implants (K023952) DeviceDscitin Nobel Biocare's NobeloirectTM 00 Implant is a threaded one-piece root form endosseous implant with an integrat…	Nobel Biocare Uas, Inc.	2003	—

Also cleared against K022562: 18 other devices →

What descends from it? (188)

See all 188

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

Number	Device	Applicant	Decided	Descendants
K063364	Alpha Bio Dental Implant System	Alpha-Bio Tec, Ltd.	2007	187
K132125	A.B. Dental Devices Dental Implants System	A.B. Dental Devices, Ltd.	2014	25

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.
Of its descendants, K063364 (Alpha-Bio Tec, Ltd., 2007) has gone furthest, with 187 descendants of its own.
18 other devices also cite its predicate K022562.

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 NobelDirect TM OD Implant is a root form endosseous implant intended to provide immediate retention for a removable tissue-supported overdenture. The NobelDirect OD Implant is used in the intra-foraminal area of the anterior mandible for the fully edentulous lower arch.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041876 · printed Nov 4, 2026

Cite this page

510(k) Report. “K041876: Nobeldirect OD Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041876

Report an extraction error

Are you the manufacturer?

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