510(k) · Cleared

Cleared

Astra Tech Implant Dental System

K974738510(k) TraditionalCleared Nov 19, 1998335-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 Nov 19, 1998 as substantially equivalent to K931767 (Astra Tech, Inc., 1994) after a 335-day review. Its family tree reaches back 1 generation to 1994. 543 later devices descend from it.

Decided: Nov 19, 1998
Review: 335 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K931767 (1994). 543 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
This deviceK974738 Astra Tech Implant Dental SystemAstra Tech, Inc. · 1998
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 · cites it directly · 307 of its ownK023631 Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc. · 2002
Descendant · 4 generations on · 240 of its ownK100152 Sirona Cad/Cam SystemSirona Dental Systems GmbH · 2010

Showing 5 of 543 descendants. See all descendants

Descendants cleared per year

2002high 62 (2024) · low 1 (2002)2026

Most influential descendants

Showing 5 of 543 · 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
K023631Astra Tech Dental Implants-Ceramic AbutmentsAstra Tech, Inc. · 2002 · cites it directly307descendants
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
−1	K931767	Astra Tech Implants-Dental System	Astra Tech, Inc.	1994	—
0 (this device)	K974738	Astra Tech Implant Dental System	Astra Tech, Inc.	1998	—
+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	—
+1	K023631	Astra Tech Dental Implants-Ceramic Abutments	Astra Tech, Inc.	2002	—
+4	K100152	Sirona Cad/Cam System	Sirona Dental Systems GmbH	2010	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2002	1	0
2003	1	0
2004	1	0
2005	3	0
2006	4	0
2007	10	0
2008	4	0
2009	5	0
2010	5	0
2011	14	0
2012	13	0
2013	19	0
2014	14	0
2015	25	0
2016	29	0
2017	32	0
2018	28	0
2019	25	0
2020	43	0
2021	40	0
2022	37	0
2023	56	0
2024	62	0
2025	44	0
2026	28	0

FIG. 1 — Lineage of K974738, 1994–2026Source: 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? (4)

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
*	K931767	Astra Tech Implants-Dental System Summary page 1 …ONAL COMPONENTS for single-tooth and multiple tooth constructions. Classification Name Endosseous Implant Predicate Devices Similar Devices Previously Approved Under K931767 - Astra Tech Implants - Dental System (Abutment Screw ST, Healing Abutment, Angled Abutment Adapter) Steri-Oss Dental Implants -…	Astra Tech, Inc.	1994	—
*	—	Steri-Oss Dental Implants - Esthetic Abutment System Named without a submission number			—
*	—	Steri-Oss Implants Friction Drive Wrench Named without a submission number			—
*	—	Try-In Kit Named without a submission number			—

Also cleared against K931767: 12 other devices →

What descends from it? (543)

See all 543

6 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
K023631	Astra Tech Dental Implants-Ceramic Abutments	Astra Tech, Inc.	2002	307
K101005	Astra Tech Implant System, New Component	Astra Tech AB	2011	198
K120414	Osseospeed Plus	Astra Tech AB	2012	196
K043195	Neo Implant System	Neoss, Ltd.	2005	167
K071838	Neoss Various Titanium Abutments	Neoss, Ltd.	2007	74

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, K024111 (Astra Tech, Inc., 2003) has gone furthest, with 423 descendants of its own.
12 other devices also cite its predicate K931767.

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?

For use in selected fully edentulous and partially edentulous arches. Profile UniAbutment 4.5 22852: Prepable component that is placed in fixture for cemented bridge construction Profile UniAbutment 5.5 22855: Prepable component that is placed in fixture for cemented ultra bridge construction Profile UniAbutment 5.5 22856: Prepable component that is placed in fixture for cemented bridge construction Profile UniAbutment 7.0 22860: Prepable component that…

Read the full statement (198 words)

For use in selected fully edentulous and partially edentulous arches.

Profile UniAbutment 4.5 22852: Prepable component that is placed in fixture for cemented bridge construction

Profile UniAbutment 5.5 22855: Prepable component that is placed in fixture for cemented ultra bridge construction

Profile UniAbutment 5.5 22856: Prepable component that is placed in fixture for cemented bridge construction

Profile UniAbutment 7.0 22860: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment 4.5 22782: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment 5.5 22785: Prepable component that is placed in fixture for cemented ultra bridge construction

Profile BiAbutment 5.5 22786: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment 7.0 22790: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment ST 4.5 22870: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment ST 5.5 22872: Prepable component that is placed in fixture for cemented bridge construction

Profile BiAbutment ST 7.0 22874: Prepable component that is placed in fixture for cemented bridge construction

Abutment Screw ST, short 22554: Screw that is used to attach the Profile BiAbutment ST to the fixture

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K974738 · printed Nov 6, 2026

Cite this page

510(k) Report. “K974738: Astra Tech Implant 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/K974738

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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