510(k) · Cleared

Recalled · Class II · 2015

Replace Tiunite Endosseous Implant

K023113510(k) SpecialCleared Sep 26, 20027-day reviewClass II21 CFR 872.3640Recalls 27

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 26, 2002 as substantially equivalent to K993595 (Nobel Biocare Uas, Inc., 2000) after a 7-day review. Its family tree reaches back 3 generations to 1990. 689 later devices descend from it. It has been recalled 27 times.

Decided: Sep 26, 2002
Review: 7 days
Class: Class II
Product code: DZE
Recalls: 27
Predicates: 1

Its longest line of descent runs back 3 generations to K894595 (1990). 10 ancestors in all. 689 later devices descend from it, 17 citing it directly.

By dateBy generation

Root · 3 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
2 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
1 generation backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
This deviceK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002
Descendant · cites it directly · 622 of its ownK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
Descendant · 2 generations on · 532 of its ownK050705 Tiunite ImplantsNobel Biocare AB · 2005 · Recalled
Descendant · 2 generations on · 511 of its ownK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
Descendant · 3 generations on · 507 of its ownK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
Descendant · 4 generations on · 414 of its ownK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled

Showing 5 of 689 descendants. See all descendants

Descendants cleared per year

2004high 66 (2024) · low 3 (2004)2026

Most influential descendants

Showing 5 of 689 · See all

K041661Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004 · cites it directly622descendants
K050705Tiunite ImplantsNobel Biocare AB · 2005 · 2 generations on532descendants
K050258Groovy ImplantsNobel Biocare AB · 2005 · 2 generations on511descendants
K061003SFB & CFB ImplantsNobel Biocare AB · 2006 · 3 generations on507descendants
K071370Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · 4 generations on414descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K894595	Bonefit R Screw Implants	Institut Straumann AG	1990	—
−2	K984104	Iti Dental Implant System	Straumann USA	1999	1
−1	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon…	Nobel Biocare Uas, Inc.	2000	—
0 (this device)	K023113	Replace Tiunite Endosseous Implant	Nobel Biocare Uas, Inc.	2002	—
+1	K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	—
+2	K050705	Tiunite Implants	Nobel Biocare AB	2005	1
+2	K050258	Groovy Implants	Nobel Biocare AB	2005	28
+3	K061003	SFB & CFB Implants	Nobel Biocare AB	2006	—
+4	K071370	Nobelactive Internal Connection Implant	Nobel Biocare AB	2007	4

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1993	1	0
1994	2	0
1996	2	0
1997	1	0
1998	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2004	3	0
2005	5	0
2006	11	0
2007	7	0
2008	12	0
2009	15	0
2010	16	0
2011	23	0
2012	20	0
2013	31	0
2014	32	0
2015	37	0
2016	36	0
2017	30	0
2018	32	0
2019	34	0
2020	49	0
2021	45	0
2022	46	0
2023	55	0
2024	66	0
2025	56	0
2026	28	0

FIG. 1 — Lineage of K023113, 1990–2026Source: 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? (1)

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
*	K993595	Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon Placement) Summary page 1 …R 872.3640) Trade or Proprietary or Model Name: Replace TiUnite Endosseous Implant Legally Marketed Device: Modified Surface Implant (K993 595) Device Description: The Replace TiUnite endosseous implant is a threaded root-form dental implant. It comes in widths of 3.5mm,…	Nobel Biocare Uas, Inc.	2000	—

Also cleared against K993595: 6 other devices →

What descends from it? (689)

See all 689

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

Number	Device	Applicant	Decided	Descendants
K041661	Nobel Biocare Endosseous Implants	Nobel Biocare Uas, Inc.	2004	622
K041236	Procera Implant Bridge, Models 15-1001, 15-1002, 15-1051, 15-1052	Nobel Biocare AB	2004	328
K060958	Straumann Narrow Neck Implants	Straumann USA	2006	228
K062277	Atlantis Abutment in Zirconia for Nobel Biocare Replace	Atlantis Components, Inc.	2006	71
K091920	Atlantis Abutment in Zirconia, Atlantis Gemini Abutment for Nobel Replace Implants…	Astra Tech, Inc.	2009	40
K083480	Inclusive Zirconia Abutment Blanks	Inclusive Dental Solutions	2009	27
K070905	Endosseous Dental Implant System	Southern Implants, Inc.	2007	17
K120873	Zimmer ZFX Abutment for Nobel Replace Implant System	Zimmer Dental, Inc.	2012	16
K053654	Atlantis Abutment for Nobel Replace Interface	Atlantis Components, Inc.	2006	12
K110565	Abutments for Competitive Implant Systems-Nobel Replace	Biomet 3i, Inc.	2011	10

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Mar 9, 2015	Class II	Z-1432-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1419-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1437-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1416-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1425-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1427-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1438-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1440-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1431-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..
Mar 9, 2015	Class II	Z-1426-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1421-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1415-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1436-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1417-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1439-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1429-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1424-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1435-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1422-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1418-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1414-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1428-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1430-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1420-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1423-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1434-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.
Mar 9, 2015	Class II	Z-1433-2015	Nonconforming Material/Component	A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

The 5 latest of 27 recalls; the web page lists all.

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 2.7 years on median.
1 of the 10 ancestors has a recall of any class.
Of its descendants, K041661 (Nobel Biocare Uas, Inc., 2004) has gone furthest, with 622 descendants of its own.
6 other devices also cite its predicate K993595.

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 Nobel Biocare Replace TiUnite Endosseous Implant is intended to be placed in the upper or lower jaw to support prosthetic devices such as artificial teeth, and to restore patient's chewing function. This may be accomplished using a two stage surgical procedure or a single stage surgical procedure.

If the single stage surgical procedure is used, these implants may be loaded immediately following insertion - provided - at least four implants are placed and splinted with a bar. These implants must be placed predominantly in the anterior mandible (between the mental foraminae) where good initial stability of the implants with or without bi-cortical anchorage, can most often be obtained.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023113 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023113: Replace Tiunite Endosseous Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023113

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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