510(k) · Cleared

Cleared

Astra Tech Implants - Dental System

K002513510(k) TraditionalCleared Jan 4, 2001142-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 Jan 4, 2001 after a 142-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 426 later devices descend from it.

Decided: Jan 4, 2001
Review: 142 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

426 later devices descend from it, 3 citing it directly.

This deviceK002513 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 2001
Descendant · cites it directly · 423 of its ownK024111 Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003
Descendant · 2 generations on · 357 of its ownK070833 Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007
Descendant · 3 generations on · 337 of its ownK081666 Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra…Astra Tech, Inc. · 2008
Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010
Descendant · 2 generations on · 228 of its ownK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006

Showing 5 of 426 descendants. See all descendants

Descendants cleared per year

2003high 54 (2024) · low 1 (2003)2026

Most influential descendants

Showing 5 of 426 · See all

K024111Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003 · cites it directly423descendants
K070833Atlantis Abutment for Astra ImplantAtlantis Components, Inc. · 2007 · 2 generations on357descendants
K081666Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0 ImplantsAstra Tech, Inc. · 2008 · 3 generations on337descendants
K100152Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010 · 4 generations on240descendants
K060958Straumann Narrow Neck ImplantsStraumann USA · 2006 · 2 generations on228descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K002513	Astra Tech Implants - Dental System	Astra Tech, Inc.	2001	—
+1	K024111	Astra Tech Implants-Dental System Fixture Osseospeed	Astra Tech, Inc.	2003	—
+2	K070833	Atlantis Abutment for Astra Implant	Atlantis Components, Inc.	2007	—
+3	K081666	Atlantis, Atlantis Gemini, Atlantis Gemini+ Abutments for Astra Osseospeed 3.0…	Astra Tech, Inc.	2008	—
+4	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—
+2	K060958	Straumann Narrow Neck Implants	Straumann USA	2006	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	1	0
2005	1	0
2006	2	0
2007	6	0
2008	4	0
2009	3	0
2010	4	0
2011	11	0
2012	9	0
2013	12	0
2014	9	0
2015	21	0
2016	21	0
2017	21	0
2018	23	0
2019	21	0
2020	32	0
2021	32	0
2022	31	0
2023	44	0
2024	54	0
2025	40	0
2026	23	0

FIG. 1 — Lineage of K002513, 2001–2026Source: 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? (426)

See all 426

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

Number	Device	Applicant	Decided	Descendants
K024111	Astra Tech Implants-Dental System Fixture Osseospeed	Astra Tech, Inc.	2003	423
K072425	Jne Implant System	GC America, Inc.	2008	1
K093749	GC Aadva Implant System	GC America, Inc.	2010	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, K024111 (Astra Tech, Inc., 2003) has gone furthest, with 423 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/K002513 · printed Nov 6, 2026

Cite this page

510(k) Report. “K002513: 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/K002513

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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