510(k) · Cleared

Cleared

Sterngold Acid Etch Dental Implant System

K023580510(k) AbbreviatedCleared Jan 17, 200385-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

Sterngold · DZE Implant, Endosseous, Root-Form

Cleared on Jan 17, 2003 after an 85-day review. The FDA summary names its predicate without a number. 4 later devices descend from it.

Decided: Jan 17, 2003
Review: 85 days
Class: Class II
Product code: DZE
Recalls: None
Predicates: 0

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

This deviceK023580 Sterngold Acid Etch Dental Implant SystemSterngold · 2003
Descendant · cites it directly · 1 of its ownK130408 Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013
Descendant · cites it directly · 1 of its ownK111798 Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM /…Sterngold Dental, LLC · 2012
Descendant · 2 generations on · 0 of its ownK193404 UF (II) Bar holder abutmentDio Corporation · 2020
Descendant · cites it directly · 0 of its ownK142667 Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC…Sterngold Dental, LLC · 2015

Most influential descendants

Showing 4 of 4 · See all

K130408Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013 · cites it directly1descendant
K111798Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM…Sterngold Dental, LLC · 2012 · cites it directly1descendant
K193404UF (II) Bar holder abutmentDio Corporation · 2020 · 2 generations on0descendants
K142667Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC…Sterngold Dental, LLC · 2015 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
0 (this device)	K023580	Sterngold Acid Etch Dental Implant System	Sterngold	2003	—
+1	K130408	Era Micro 23 Female Abutment, Era Micro 30 Female Abutment	Sterngold Dental, LLC	2013	—
+1	K111798	Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN…	Sterngold Dental, LLC	2012	—
+2	K193404	UF (II) Bar holder abutment	Dio Corporation	2020	—
+1	K142667	Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm…	Sterngold Dental, LLC	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2012	1	0
2013	1	0
2015	1	0
2020	1	0

FIG. 1 — Lineage of K023580, 2003–2020Source: 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? (2)

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
*	—	Implant Innovations Osseotite Dental Implant System Named without a submission number			—
*	—	Nobel Biocare MKIII Dental Implant System Named without a submission number			—

What descends from it? (4)

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

Number	Device	Applicant	Decided	Descendants
K130408	Era Micro 23 Female Abutment, Era Micro 30 Female Abutment	Sterngold Dental, LLC	2013	1
K111798	Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM…	Sterngold Dental, LLC	2012	1
K142667	Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC…	Sterngold Dental, LLC	2015	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, K130408 (Sterngold Dental, LLC, 2013) has gone furthest, with 1 descendant 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	—

What is it indicated for?

The Sterngold Acid Etch Dental Implant System consists of endosseous dental implants indicated:

For implantation into any area of the fully endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

For implantation into any area of the partially endentulous maxilla and mandible for the support of a removable or fixed dental prosthesis

For single tooth or multiple unit prosthesis

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K023580 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023580: Sterngold Acid Etch Dental Implant System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023580

Report an extraction error

Are you the manufacturer?

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