510(k) · Cleared

Cleared

Endosseous Implant

K021355510(k) TraditionalCleared Aug 30, 2002123-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

Branemark Integration AB · DZE Implant, Endosseous, Root-Form

Cleared on Aug 30, 2002 as substantially equivalent to K925765 (Nobelpharma USA, Inc., 1993) after a 123-day review. Its family tree reaches back 1 generation to 1993. 5 later devices descend from it.

Decided: Aug 30, 2002
Review: 123 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K925765 (1993). 5 later devices descend from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK925765 Branemark System Standard 3.75MM FixtureNobelpharma USA, Inc. · 1993
This deviceK021355 Endosseous ImplantBranemark Integration AB · 2002
Descendant · cites it directly · 4 of its ownK062931 Implus Implant SystemLeader Italia S.R.L. · 2007
Descendant · 2 generations on · 2 of its ownK183024 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020
Descendant · 3 generations on · 0 of its ownK202832 Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021
Descendant · 2 generations on · 0 of its ownK192839 DSP Implant SystemD.S.P Industrial Eireli · 2021
Descendant · 2 generations on · 0 of its ownK120792 Tixos Implant SystemLeader Italia S.R.L. · 2012

Most influential descendants

Showing 5 of 5 · See all

K062931Implus Implant SystemLeader Italia S.R.L. · 2007 · cites it directly4descendants
K183024Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2020 · 2 generations on2descendants
K202832Implacil Implant SystemImplacil DE Bortoli Material Odontologico Ltda · 2021 · 3 generations on0descendants
K192839DSP Implant SystemD.S.P Industrial Eireli · 2021 · 2 generations on0descendants
K120792Tixos Implant SystemLeader Italia S.R.L. · 2012 · 2 generations on0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K925765	Branemark System Standard 3.75MM Fixture	Nobelpharma USA, Inc.	1993	—
0 (this device)	K021355	Endosseous Implant	Branemark Integration AB	2002	—
+1	K062931	Implus Implant System	Leader Italia S.R.L.	2007	—
+2	K183024	Implacil Implant System	Implacil DE Bortoli Material Odontologico Ltda	2020	—
+3	K202832	Implacil Implant System	Implacil DE Bortoli Material Odontologico Ltda	2021	—
+2	K192839	DSP Implant System	D.S.P Industrial Eireli	2021	—
+2	K120792	Tixos Implant System	Leader Italia S.R.L.	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2012	1	0
2020	1	0
2021	2	0

FIG. 1 — Lineage of K021355, 1993–2021Source: 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
*	K925765	Branemark System Standard 3.75MM Fixture Summary page 2 …Diameter 3,75 111111, Diameter 3,75 nun Length 7-20 mm Length 8,5-15 mm 5 1O(k) K925 765 No number yet 6. Discussion of performance testing. Mechanical testing requested for Screw…	Nobelpharma USA, Inc.	1993	—

Also cleared against K925765: 4 other devices →

What descends from it? (5)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K062931	Implus Implant System	Leader Italia S.R.L.	2007	4

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, K062931 (Leader Italia S.R.L., 2007) has gone furthest, with 4 descendants of its own.
4 other devices also cite its predicate K925765.

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 Brinemark Integration AB,FIXTURE ORIGINAL is intended for surgical placement into the bone of upper /lower jaw arches as a permanent anchorage for prosthetic devices and to restore chewing function.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K021355 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021355: Endosseous Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021355

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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