510(k) · Cleared
ClearedSfi-Bar Implant Abutments
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 Feb 25, 2014 as substantially equivalent to K130183 (Sterngold Dental, LLC, 2013) and 1 other predicate after a 169-day review. Its family tree reaches back 3 generations to 2010. 6 later devices descend from it.
- Decided
- Feb 25, 2014
- Review
- 169 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K083876 (2010). 6 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK083876 Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA · 2010
- 2 generations backK102382 Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss…Cendres & Metaux SA · 2010
- 1 generation backK130183 Sfi Bar AbutmentsSterngold Dental, LLC · 2013
- This deviceK132814 Sfi-Bar Implant AbutmentsSterngold Dental, LLC · 2014
- Descendant · cites it directly · 2 of its ownK143051 ArgenIS Titanium AbutmentsThe Argen Corporation · 2015
- Descendant · 2 generations on · 1 of its ownK160248 ArgenIS Titanium AbutmentsArgen Corporation · 2016
- Descendant · cites it directly · 1 of its ownK142407 Straight Stud AttachmentSterngold Dental, LLC · 2014
- Descendant · 3 generations on · 0 of its ownK172430 ArgenIS Titanium AbutmentsArgen Corporation · 2018
- Descendant · 2 generations on · 0 of its ownK150250 SternSnap Angled AttachmentSterngold Dental, LLC · 2015
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K143051ArgenIS Titanium AbutmentsThe Argen Corporation · 2015 · cites it directly2descendants
- K160248ArgenIS Titanium AbutmentsArgen Corporation · 2016 · 2 generations on1descendant
- K142407Straight Stud AttachmentSterngold Dental, LLC · 2014 · cites it directly1descendant
- K172430ArgenIS Titanium AbutmentsArgen Corporation · 2018 · 3 generations on0descendants
- K150250SternSnap Angled AttachmentSterngold Dental, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K083876 | Sfi-Bar System Complete 2-Implant and 4-Implant | Cendres & Metaux SA | 2010 | — |
| −2 | K102382 | Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant | Cendres & Metaux SA | 2010 | — |
| −1 | K130183 | Sfi Bar Abutments | Sterngold Dental, LLC | 2013 | — |
| 0 (this device) | K132814 | Sfi-Bar Implant Abutments | Sterngold Dental, LLC | 2014 | — |
| +1 | K143051 | ArgenIS Titanium Abutments | The Argen Corporation | 2015 | — |
| +2 | K160248 | ArgenIS Titanium Abutments | Argen Corporation | 2016 | — |
| +1 | K142407 | Straight Stud Attachment | Sterngold Dental, LLC | 2014 | — |
| +3 | K172430 | ArgenIS Titanium Abutments | Argen Corporation | 2018 | — |
| +2 | K150250 | SternSnap Angled Attachment | Sterngold Dental, LLC | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K130183 | Sfi Bar AbutmentsSummary page 1…Product Code: NHA (21CFR 872.3630) Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): Ki130183, K1 02382. K130183 SFI Bar® Implant Abutments for 7 Platforms K 102382 SF1 Bar® Implant Adapter Straumann, SFI Bar®D Implant Ad… | 2013 |
| * | K102382 | Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantSummary page 1…Class 11 Product Code: NHA (21CFR 872.3630) Legally Marketed Device to which Equivalence is claimed (Predicate Devices): Predicate Device(s): Ki130183, K1 02382. K130183 SFI Bar® Implant Abutments for 7 Platforms K 102382 SF1 Bar® Implant Adapter Straumann, SFI Bar®D… | 2010 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 4 years and passes through 2 companies; a new generation was cleared every 9 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K143051 (The Argen Corporation, 2015) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K130183.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 SFI-Baro Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /0r retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants. The SFI-Bare Implant Abutments are compatible with the following implant systems: Implant Brand — Model Straumann — Straumann Bone…
Read the full statement (169 words)
The SFI-Baro Implant Abutments are indicated to be used with dental implants as a prosthetic framework to support and /0r retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The abutment screws are intended to secure the bar to the endosseous implants.
The SFI-Bare Implant Abutments are compatible with the following implant systems:
Implant Brand — Model
Straumann — Straumann Bone Level RC, Blue Sky Blo Square Taper RC
Straunann — Straumann Bone Level NC, Blue Sky Blo Square Taper NC
Ankylos — Ankylos
Nobel Biocare — Nobel Replace WP, Nobel Replace Select WP, NobelSpeedy Replace WP, Implant Direct 5.0 Replant, BlueSky Bio 5.0 Trilobe
Nobel Biocare — Nobel Conical Connection RP'
Nobel Biocare — Nobel Conical Connection NP, Blue Sky Bio Max
Astra Dental — Astra 4.5 / 5.0, Blue Sky Sic Conus 12 4.5 / 5.0
AstraDental — Astra 3.51/4.0, Blue Sky Bio Conus 12 3.5 /4.0
Zimmer Dental — Zimmer TSV 5.7mm. Implant Direct Legacy 5.7, BioHorizon 5.7
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132814 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132814: Sfi-Bar Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132814
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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