510(k) · Cleared

Cleared

Universal, Aesthetica, Natea, Natura

K083670510(k) TraditionalCleared Jul 23, 2009224-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

Euroteknika · DZE Implant, Endosseous, Root-Form

Cleared on Jul 23, 2009 as substantially equivalent to K040643 (Branemark Integration AB, 2004) and 3 other predicates after a 224-day review. Its family tree reaches back 3 generations to 1994.

Decided: Jul 23, 2009
Review: 224 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 4

Its longest line of descent runs back 3 generations to K931767 (1994). 11 ancestors in all. No later device cites it as a predicate yet.

By dateBy generation

Root · 3 generations backK931767 Astra Tech Implants-Dental SystemAstra Tech, Inc. · 1994
2 generations backK980698 Astra Tech Implants - Dental SystemAstra Tech, Inc. · 1998
1 generation backK024111 Astra Tech Implants-Dental System Fixture OsseospeedAstra Tech, Inc. · 2003
This deviceK083670 Universal, Aesthetica, Natea, NaturaEuroteknika · 2009

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−3	K931767	Astra Tech Implants-Dental System	Astra Tech, Inc.	1994	—
−2	K980698	Astra Tech Implants - Dental System	Astra Tech, Inc.	1998	—
−1	K024111	Astra Tech Implants-Dental System Fixture Osseospeed	Astra Tech, Inc.	2003	—
0 (this device)	K083670	Universal, Aesthetica, Natea, Natura	Euroteknika	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1997	1	0
1998	1	0
1999	2	0
2001	2	0
2003	1	0
2004	1	0

FIG. 1 — Lineage of K083670, 1994–2009Source: 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

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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
*	K040643	Branemark Integration Dental Implant and Accessories Summary page 1 …edica') UNIVERSAL (Nobel BrAnemark MkIII) Innova Life 5.0x 5MM endopore Endosseous (K 040643) dental implant system ________________________________…	Branemark Integration AB	2004	—
*	K032140	5.0 X 5MM Endopore Endosseous Dental Implant System Summary page 1 …(K 040643) dental implant system ____________________________________(K 032140) NATURA Astra Tech Zimmer (Sulzer Dental / Sulzer Medica) Swiss…	Innova Life Sciences Corp.	2003	—
*	K024111	Astra Tech Implants-Dental System Fixture Osseospeed Summary page 1 …/ Sulzer Medica) Swiss Micro-thread Fixtures Plus Conical _______________ ~~(K 024111) (K011245) NATEA Astra Tech Zim…	Astra Tech, Inc.	2003	—
*	K011245	Advent Implant System, Swiss Plus Implant System Summary page 1 …Micro-thread Fixtures Plus Conical _______________ ~~(K 024111) (K011245) NATEA Astra Tech Zimmer (Sulzer Dental I Sulzer Medica) Swiss…	Sulzer Dental, Inc.	2001	—

What descends from it?

No later submission names this one as a predicate yet.

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?

The line of descent spans 15 years and passes through 2 companies; a new generation was cleared every 5.2 years on median.
None of the 11 ancestors has a recall.

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. 2009, this device’s year, is highlighted.

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 device is intended for surgical placement in maxillary and/or mandibular arch to support crowns, bridges, overdentures in edentulous or partially edentulous patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K083670 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083670: Universal, Aesthetica, Natea, Natura.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083670

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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