510(k) Report

510(k) · Cleared

Cleared

Sterngold 2.2MM Angles Micro Era Dental Implant System

K092434510(k) AbbreviatedCleared Nov 10, 200995-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 Nov 10, 2009 after a 95-day review. The FDA summary names its predicate without a number. 8 later devices descend from it.

Decided
Nov 10, 2009
Review
95 days
Class
Class II
Product code
DZE
Recalls
None
Predicates
0

8 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2015: 1 descendant cleared2024: 1 descendant cleared2019: 1 descendant cleared2023: 2 descendants cleared2025: 2 descendants cleared2026: 1 descendant cleared20052010201520202025
  1. This deviceK092434 Sterngold 2.2MM Angles Micro Era Dental Implant SystemSterngold · 2009
  2. Descendant · cites it directly · 7 of its ownK142167 Medentika Abutment SystemMedentika GmbH · 2015
  3. Descendant · 2 generations on · 3 of its ownK223113 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2024
  4. Descendant · 2 generations on · 2 of its ownK180564 Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika…Medentika GmbH · 2019
  5. Descendant · 3 generations on · 1 of its ownK191111 DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023
  6. Descendant · 3 generations on · 0 of its ownK260460 Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026

Showing 5 of 8 descendants. See all descendants

Descendants cleared per year

2015: 12019: 12023: 22024: 12025: 22026: 1
2015high 2 (2023) · low 0 (2016)2026

Most influential descendants

Showing 5 of 8 · See all
  • K142167Medentika Abutment SystemMedentika GmbH · 2015 · cites it directly7descendants
  • K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases…Medentika GmbH · 2024 · 2 generations on3descendants
  • K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBasesMedentika GmbH · 2019 · 2 generations on2descendants
  • K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH · 2023 · 3 generations on1descendant
  • K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG · 2026 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K092434Sterngold 2.2MM Angles Micro Era Dental Implant SystemSterngold2009—
+1K142167Medentika Abutment SystemMedentika GmbH2015—
+2K223113Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM…Medentika GmbH2024—
+2K180564Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM…Medentika GmbH2019—
+3K191111DD Solid Connect® CAD/CAM AbutmentsDental Direkt GmbH2023—
+3K260460Neodent Gold Hue Custom Abutments, Medentika Custom Abutments Gold HueInstitut Straumann AG2026—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201510
201910
202320
202410
202520
202610
FIG. 1 — Lineage of K092434, 2009–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K211090 ZENEX Implant Systemscore 25.4 · 15 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #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.

TypeNumberDeviceApplicantDecidedRecalls
*—Sterngold ERA Dental Implant System
Named without a submission number
—
*—Sterngold Narrow Platform Hex Screw Implants
Named without a submission number
—

What descends from it? (8)

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

NumberDeviceApplicantDecidedDescendants
K142167Medentika Abutment SystemMedentika GmbH20157

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, K142167 (Medentika GmbH, 2015) has gone furthest, with 7 descendants 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. 2009, this device’s year, is highlighted.

FDA decisions per year · DZE

31in 2025

2007: 432008: 612009: 412010: 342011: 262012: 392013: 422014: 362015: 362016: 402017: 482018: 412019: 312020: 412021: 342022: 342023: 352024: 402025: 312026 (partial year): 15
2007high 61 (2008) · low 26 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DZE

184in 2025

2007: 107 days median2008: 118 days median2009: 110 days median2010: 162 days median2011: 194 days median2012: 174 days median2013: 195 days median2014: 265 days median2015: 215 days median2016: 219 days median2017: 223 days median2018: 200 days median2019: 231 days median2020: 230 days median2021: 182 days median2022: 243 days median2023: 248 days median2024: 222 days median2025: 184 days median2026 (partial year): 194 days median
2007high 265 (2014) · low 107 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DZE

1in 2025

2007: 112008: 42009: 32010: 32012: 112013: 12014: 72015: 32016: 152017: 42018: 42019: 82021: 62024: 12025: 12026 (partial year): 2
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

2007: 2252008: 3932009: 1642010: 3602011: 3622012: 3582013: 3912014: 1,1242015: 2,8942016: 1,1162017: 9,7192018: 12,8922019: 167,0162020: 255,5242021: 479,6182022: 483,2242023: 537,5852024: 473,6292025: 465,788
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20074310711225
2008611184393
2009411103164
2010341623360
2011261940362
20123917411358
2013421951391
20143626571,124
20153621532,894
201640219151,116
20174822349,719
201841200412,892
2019312318167,016
2020412300255,524
2021341826479,618
2022342430483,224
2023352480537,585
2024402221473,629
2025311841465,788
2026151942—

What is it indicated for?

The Sterngold 2.2mm Angled ERA dental implants are intended for long term as well as temporary surgical implantation in the bone of the patient's upper or lower arch to provide immediate load or delayed load of prosthetic systems, such as artificial teeth, in order to restore the patient's chewing function.

Immediate loading of the ERA Implant should only occur when the position of the implants provides adequate bone quantity and quality to allow proper immediate mechanical stabilization of the self-tapping screw into the bone and where occlusal and lateral forces can be limited with appropriate occlusal design and a soft diet.

Indications for use as stated in the FDA summary.

More from Sterngold

12 FDA decisions under this applicant name. See the company

  • K041271Sterngold 3.25 Era Dental Implant SystemSterngold · 2004
  • K023580Sterngold Acid Etch Dental Implant SystemSterngold · 2003
  • K022252Sterngold 1, Model 1127781Sterngold · 2002
  • K021741Critertion, Model #1067511Sterngold · 2002
  • K021045Era ImplantSterngold · 2002

Recent decisions in DZE

The DZE category page

  • K261295MultiNeO Dental Implant SystemAlpha Bio Tec, Ltd. · 2026
  • K261392TriActive Dental Implant SystemParagon Implant Mfg., LLC · 2026
  • K260463ZEROS Dental Implant SystemZeros Co., Ltd. · 2026
  • K251188UNIQA® Dental Implants SystemUniqa Dental, Ltd. · 2026
  • K251232MegaGen Zygoma Dental Implant SystemMegagen Implant Co., Ltd. · 2026

https://510kreport.com/device/K092434 · printed Nov 4, 2026

Cite this page

510(k) Report. “K092434: Sterngold 2.2MM Angles Micro Era Dental 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/K092434

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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