510(k) · Cleared

Cleared

Replace Scalloped Margin Implant System

K021584510(k) SpecialCleared Jun 5, 200222-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

Nobel Biocare Uas, Inc. · DZE Implant, Endosseous, Root-Form

Cleared on Jun 5, 2002 as substantially equivalent to K962845 (Steri-Oss, Inc., 1996) after a 22-day review. Its family tree reaches back 1 generation to 1996. 12 later devices descend from it.

Decided: Jun 5, 2002
Review: 22 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K962845 (1996). 12 later devices descend from it, 6 citing it directly.

By dateBy generation

Root · 1 generation backK962845 Replace HA Coated ImplantsSteri-Oss, Inc. · 1996
This deviceK021584 Replace Scalloped Margin Implant SystemNobel Biocare Uas, Inc. · 2002
Descendant · cites it directly · 4 of its ownK052471 HDC Spider ScrewHdc S.R.L. · 2005
Descendant · cites it directly · 4 of its ownK030257 Nobel Perfect Implant SystemNobel Biocare Uas, Inc. · 2003
Descendant · cites it directly · 3 of its ownK033724 Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc. · 2004
Descendant · 2 generations on · 2 of its ownK071851 HDC Sterile Spider ScrewHdc S.R.L. · 2007
Descendant · 2 generations on · 2 of its ownK040573 Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc. · 2004

Showing 5 of 12 descendants. See all descendants

Descendants cleared per year

2003high 2 (2004) · low 0 (2006)2026

Most influential descendants

Showing 5 of 12 · See all

K052471HDC Spider ScrewHdc S.R.L. · 2005 · cites it directly4descendants
K030257Nobel Perfect Implant SystemNobel Biocare Uas, Inc. · 2003 · cites it directly4descendants
K033724Nobel Biocare Centric Post, Models 31234, 31235 and 31236Nobel Biocare Uas, Inc. · 2004 · cites it directly3descendants
K071851HDC Sterile Spider ScrewHdc S.R.L. · 2007 · 2 generations on2descendants
K040573Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236Nobel Biocare Uas, Inc. · 2004 · 2 generations on2descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K962845	Replace HA Coated Implants	Steri-Oss, Inc.	1996	—
0 (this device)	K021584	Replace Scalloped Margin Implant System	Nobel Biocare Uas, Inc.	2002	—
+1	K052471	HDC Spider Screw	Hdc S.R.L.	2005	—
+1	K030257	Nobel Perfect Implant System	Nobel Biocare Uas, Inc.	2003	—
+1	K033724	Nobel Biocare Centric Post, Models 31234, 31235 and 31236	Nobel Biocare Uas, Inc.	2004	—
+2	K071851	HDC Sterile Spider Screw	Hdc S.R.L.	2007	—
+2	K040573	Nobel Biocare Permanent Centric Post, Models 31234, 31235, 31236	Nobel Biocare Uas, Inc.	2004	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2003	1	0
2004	2	0
2005	2	0
2007	2	0
2009	2	0
2010	1	0
2013	1	0
2017	1	0

FIG. 1 — Lineage of K021584, 1996–2017Source: 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? (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
*	K962845	Replace HA Coated Implants Summary page 1 …Proprietary or Replacem Scalloped mgin Implant System Model Name: Legally Marketed Device: Replacem HA Coated Implant K962845 Device Description: The Replacew Scalloped Margin Implant System is an implant with a scalloped coronal margin designed t…	Steri-Oss, Inc.	1996	—

Also cleared against K962845: 3 other devices →

What descends from it? (12)

See all 12

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

Number	Device	Applicant	Decided	Descendants
K052471	HDC Spider Screw	Hdc S.R.L.	2005	4
K030257	Nobel Perfect Implant System	Nobel Biocare Uas, Inc.	2003	4
K033724	Nobel Biocare Centric Post, Models 31234, 31235 and 31236	Nobel Biocare Uas, Inc.	2004	3
K050444	Nobelreplace Adapter, Model 32412	Nobel Biocare Uas, Inc.	2005	1
K172854	NobelPerfect Abutments	Nobel Biocare AB	2017	0
K101068	Accufit Dental Implant Abutments & Screws	Radiant Express, LLC	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?

Its one ancestor has no recall.
Of its descendants, K052471 (Hdc S.R.L., 2005) has gone furthest, with 4 descendants of its own.
3 other devices also cite its predicate K962845.

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 Replacem Scalloped Margin Implant System is an implant with a scalloped coronal margin, designed for single stage or two stage surgical procedures. The Replacem Scalloped Margin Implant System is intended for use to restore chewing fkction in edentulous and/or partially edentulous patients.

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/K021584 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021584: Replace Scalloped Margin Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021584

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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