510(k) · Cleared

Cleared

Astra Tech Implants - Dental System

K041492510(k) TraditionalCleared Aug 9, 200466-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

Astra Tech, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Aug 9, 2004 as substantially equivalent to K022562 (Nobel Biocare AB, 2002) after a 66-day review. Its family tree reaches back 1 generation to 2002. 360 later devices descend from it.

Decided: Aug 9, 2004
Review: 66 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K022562 (2002). 360 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 deviceK041492 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 2004
Descendant · cites it directly · 304 of its ownK073075 Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental…Dentsply International, Inc. · 2008
Descendant · 2 generations on · 290 of its ownK083805 Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009
Descendant · 2 generations on · 200 of its ownK093780 Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment…Astra Tech, Inc. · 2010
Descendant · 3 generations on · 199 of its ownK101004 Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini…Astra Tech, Inc. · 2010
Descendant · 4 generations on · 197 of its ownK120338 Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later…Astra Tech, Inc. · 2012

Showing 5 of 360 descendants. See all descendants

Descendants cleared per year

2005high 41 (2025) · low 0 (2006)2026

Most influential descendants

Showing 5 of 360 · See all

K073075Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant SystemsDentsply International, Inc. · 2008 · cites it directly304descendants
K083805Ankylos C/X Dental Implant SystemDentsply Intl., Inc. · 2009 · 2 generations on290descendants
K093780Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis Gemini +…Astra Tech, Inc. · 2010 · 2 generations on200descendants
K101004Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment, Atlantis…Astra Tech, Inc. · 2010 · 3 generations on199descendants
K120338Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in ZirconiaAstra Tech, Inc. · 2012 · 4 generations on197descendants

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)	K041492	Astra Tech Implants - Dental System	Astra Tech, Inc.	2004	—
+1	K073075	Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems	Dentsply International, Inc.	2008	—
+2	K083805	Ankylos C/X Dental Implant System	Dentsply Intl., Inc.	2009	—
+2	K093780	Atlantis Abutment for Dentsply Implant, Atlantis Gemini Abutment, Atlantis…	Astra Tech, Inc.	2010	—
+3	K101004	Atlantis Abutment for Dentsply Ankylos Implant, Atlantis Gemini Abutment…	Astra Tech, Inc.	2010	—
+4	K120338	Atlantis in Zirconia for Dentsply Ankylos Implant, Atlantis Later Abutment in…	Astra Tech, Inc.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2005	1	0
2007	1	0
2008	1	0
2009	3	0
2010	2	0
2011	4	0
2012	5	0
2013	4	0
2014	16	0
2015	18	0
2016	19	0
2017	16	0
2018	17	0
2019	25	0
2020	26	0
2021	26	0
2022	32	0
2023	37	0
2024	40	0
2025	41	0
2026	26	0

FIG. 1 — Lineage of K041492, 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? (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
*	K022562	Various Branemark System Implants-Immediate Function Indication Summary page 2 …osseous Dental Implant Identification of legally market device Various Brlnemark System Dental Implant products, submitted by Nobel BioCare under 510(k) K022562 Description of Device The Astra Tech Dental Implants are root-formed threaded screws made from commercially pure titanium. Th…	Nobel Biocare AB	2002	—

Also cleared against K022562: 18 other devices →

What descends from it? (360)

See all 360

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

Number	Device	Applicant	Decided	Descendants
K073075	Frialit Plus, Xive S Plus, Xive TG Plus, Ankylos Plus, Dental Implant Systems	Dentsply International, Inc.	2008	304
K043195	Neo Implant System	Neoss, Ltd.	2005	167

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?

Its one ancestor has no recall.
Of its descendants, K073075 (Dentsply International, Inc., 2008) has gone furthest, with 304 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 Astra Tech Implants - Dental System are for single-stage or two-stage surgical procedures and cement or screw retained restorations. The Astra Tech Implants - Dental System are intended for immediate placement and function on single tooth and/or multiple tooth applications recognizing sufficient bone stability (type I or II bone) and appropriate occlusal loading, to restore chewing function. Multiple tooth applications may be splinted with a bar.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K041492 · printed Nov 6, 2026

Cite this page

510(k) Report. “K041492: Astra Tech Implants - Dental System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K041492

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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