510(k) · Cleared
ClearedEra Micro 23 Female Abutment, Era Micro 30 Female Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterngold Dental, LLC · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 1, 2013 as substantially equivalent to K921010 (Apm Stern Gold, 1992) and 2 other predicates after a 132-day review. Its family tree reaches back 12 generations to 1990. 1 later device descends from it.
- Decided
- Jul 1, 2013
- Review
- 132 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to K894595 (1990). 51 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 8 generations between
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK121810 Osseospeed Angled Abutment EVAstra Tech AB · 2013
- This deviceK130408 Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013
- Descendant · cites it directly · 0 of its ownK193404 UF (II) Bar holder abutmentDio Corporation · 2020
Show all 12 generations
- Root · 12 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 11 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 10 generations backK993595 Nobel Biocare's Modified Surface Implant (Intended for Immediate…Nobel Biocare Uas, Inc. · 2000
- 9 generations backK023113 Replace Tiunite Endosseous ImplantNobel Biocare Uas, Inc. · 2002 · Recalled
- 8 generations backK041661 Nobel Biocare Endosseous ImplantsNobel Biocare Uas, Inc. · 2004
- 7 generations backK050258 Groovy ImplantsNobel Biocare AB · 2005 · Recalled
- 6 generations backK061003 SFB & CFB ImplantsNobel Biocare AB · 2006
- 5 generations backK071370 Nobelactive Internal Connection ImplantNobel Biocare AB · 2007 · Recalled
- 4 generations backK101732 Astra Tech Implant SystemAstra Tech AB · 2011
- 3 generations backK111287 Astra Tech Implant SystemAstra Tech AB · 2011
- 2 generations backK112138 Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus ImplantAstra Tech, Inc. · 2011
- 1 generation backK121810 Osseospeed Angled Abutment EVAstra Tech AB · 2013
- This deviceK130408 Era Micro 23 Female Abutment, Era Micro 30 Female AbutmentSterngold Dental, LLC · 2013
Most influential descendants
Showing 1 of 1 · See all- K193404UF (II) Bar holder abutmentDio Corporation · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −11 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −10 | K993595 | Nobel Biocare's Modified Surface Implant (Intended for Immediate Loading Upon… | Nobel Biocare Uas, Inc. | 2000 | — |
| −9 | K023113 | Replace Tiunite Endosseous Implant | Nobel Biocare Uas, Inc. | 2002 | 27 |
| −8 | K041661 | Nobel Biocare Endosseous Implants | Nobel Biocare Uas, Inc. | 2004 | — |
| −7 | K050258 | Groovy Implants | Nobel Biocare AB | 2005 | 28 |
| −6 | K061003 | SFB & CFB Implants | Nobel Biocare AB | 2006 | — |
| −5 | K071370 | Nobelactive Internal Connection Implant | Nobel Biocare AB | 2007 | 4 |
| −4 | K101732 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −3 | K111287 | Astra Tech Implant System | Astra Tech AB | 2011 | — |
| −2 | K112138 | Atlantis Abutment in Zirconia for Astra Tech Osseospeed Plus Implant | Astra Tech, Inc. | 2011 | — |
| −1 | K121810 | Osseospeed Angled Abutment EV | Astra Tech AB | 2013 | — |
| 0 (this device) | K130408 | Era Micro 23 Female Abutment, Era Micro 30 Female Abutment | Sterngold Dental, LLC | 2013 | — |
| +1 | K193404 | UF (II) Bar holder abutment | Dio Corporation | 2020 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 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 NHA? 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 NHA device
- #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 19 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K921010 | Stern Era Alignment Correction Implant AbutmentSummary page 2…, which resides at or above the gingival crest and couples with the Stem ERA System male attachments, is coated with titanium nitride (TiN), which has been cleared under K921 0 10. No coating is applied to snap-in post of the angled female insert or the bases. Packaging: These devices are supplied non-ster… | 1992 |
| * | K121810 | Osseospeed Angled Abutment EVSummary page 1…Stem ERA® Alignment Correction Abutments (50, 110, and 17), and the Osseospeed1 m Angled Abutment EV. K92f0I0 Stem ERA® Alignment Correction Implant Abutments K121810 Osseospeed TmAngled Abutment EV K023580 Stemngold Acid Etch Dental Implant System Product Description: The ER… | 2013 |
| * | K023580 | Sterngold Acid Etch Dental Implant SystemSummary page 1…0, and 17), and the Osseospeed1 m Angled Abutment EV. K92f0I0 Stem ERA® Alignment Correction Implant Abutments K121810 Osseospeed TmAngled Abutment EV K023580 Stemngold Acid Etch Dental Implant System Product Description: The ERA®'Micro 230 and 300 Female Abutment is a prosthe… | 2003 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K193404 | UF (II) Bar holder abutment | 2020 | 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?
- The line of descent spans 23 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 51 ancestors have a recall of any class.
- Of its descendants, K193404 (Dio Corporation, 2020) has gone furthest, with 0 descendants of its own.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · NHA
40in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NHA
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NHA
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NHA
838in 2025
MAUDE reports naming product code NHA, 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 | 38 | 91 | 1 | 1 |
| 2008 | 31 | 90 | 2 | 8 |
| 2009 | 30 | 95 | 0 | 30 |
| 2010 | 19 | 162 | 0 | 61 |
| 2011 | 31 | 130 | 5 | 56 |
| 2012 | 25 | 171 | 1 | 5 |
| 2013 | 22 | 184 | 1 | 143 |
| 2014 | 27 | 160 | 0 | 146 |
| 2015 | 29 | 151 | 1 | 858 |
| 2016 | 38 | 202 | 36 | 314 |
| 2017 | 31 | 188 | 2 | 577 |
| 2018 | 31 | 200 | 1 | 591 |
| 2019 | 28 | 160 | 0 | 530 |
| 2020 | 38 | 153 | 7 | 458 |
| 2021 | 29 | 211 | 0 | 546 |
| 2022 | 33 | 142 | 0 | 497 |
| 2023 | 51 | 147 | 3 | 618 |
| 2024 | 43 | 158 | 0 | 635 |
| 2025 | 40 | 147 | 1 | 838 |
| 2026 | 23 | 169 | 3 | — |
What is it indicated for?
The ERA® Micro 23° and 30° Females are intended to be used as a retention device in conjunction with the Sterngold Acid Etch Dental Implant System in the maxillary and/or mandibular arch to provide support for overdentures for partially and fully edentulous patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130408 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130408: Era Micro 23 Female Abutment, Era Micro 30 Female Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130408
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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