510(k) · Cleared
ClearedStern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold Dental, LLC · DZE Implant, Endosseous, Root-Form
Cleared on Jan 7, 2015 as substantially equivalent to K023580 (Sterngold, 2003) and 1 other predicate after a 110-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- Jan 7, 2015
- Review
- 110 days
- Class
- Class II
- Product code
- DZE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K894844 (1990). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 2 generations backK012757 Iti Dental Implant SystemStraumann USA · 2001
- 1 generation backK111798 Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM /…Sterngold Dental, LLC · 2012
- This deviceK142667 Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC…Sterngold Dental, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −2 | K012757 | Iti Dental Implant System | Straumann USA | 2001 | — |
| −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 | — |
| 0 (this device) | K142667 | Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm… | Sterngold Dental, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
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
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 | Decided |
|---|---|---|---|
| * | K023580 | Sterngold Acid Etch Dental Implant SystemSummary page 4…marketed dental implant systems that have been cleared by FDA through the 510(k) Premarket Notification process, including the Sterngold Acid Etch Dental Implant System (K023580), and Stern IC Dental Implant System (K111798). Product Description: The proposed implant is a self-tapping, double thread scre… | 2003 |
| * | K111798 | Sternic Implant 4.2MM RN, 1.8MM, 8.0MM / 4.1MM RN, 1.8MM, 10.MM / 4.1 MM RN, 1.8MM…Summary page 4…cleared by FDA through the 510(k) Premarket Notification process, including the Sterngold Acid Etch Dental Implant System (K023580), and Stern IC Dental Implant System (K111798). Product Description: The proposed implant is a self-tapping, double thread screw implant, manufactured from pure grade 4 tita… | 2012 |
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 25 years and passes through 3 companies; a new generation was cleared every 9.5 years on median.
- None of the 7 ancestors has a recall.
- 2 other devices also cite its predicate K023580.
How does its category compare?
All DZE devicesDZE Implant, Endosseous, Root-Form: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · DZE
31in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DZE
184in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DZE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DZE
465,788in 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 Stern AC Dental Implant System can be used in dental implant applications for oral rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant retained restorations may consist of single crowns or bridges as well as complete or partial dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also indicated for immediate loading with good primary stability and appropriate occlusal…
Read the full statement (113 words)
The Stern AC Dental Implant System can be used in dental implant applications for oral
rehabilitation of edentulous and partially dentate patients in the maxilla and mandible. Implant
retained restorations may consist of single crowns or bridges as well as complete or partial
dentures. The Stern AC Dental Implant System is intended for delayed loading. It is also
indicated for immediate loading with good primary stability and appropriate occlusal loading.
The Stern AC Dental Implants are compatible with the Straumann Rn Synocta, Straumann
SynOcta Meso Abutments, Straumann RC Temporary Abutments, Straumann RC Cementable
abutments and Stern IC Solid Abutments.
The Stern AC Dental Implant System is only intended for use with straight abutments.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142667 · printed Nov 6, 2026
Cite this page
510(k) Report. “K142667: Stern AC 3.3x10mm, Stern AC 3.3x11.5mm, Stern AC 3.3x13mm, Stern AC 4.0x8.5mm, Stern AC 4.0x10mm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142667
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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