510(k) · Cleared
ClearedSfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-Bar (R) Implant Adapter Stra..
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cendres & Metaux SA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 12, 2011 as substantially equivalent to K073628 (Straumann USA, 2008) and 2 other predicates after a 117-day review. Its family tree reaches back 4 generations to 1990. 201 later devices descend from it.
- Decided
- Sep 12, 2011
- Review
- 117 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894844 (1990). 7 ancestors in all. 201 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 2 generations backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- 1 generation backK073628 Synocta AbutmentsStraumann USA · 2008
- This deviceK111390 Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0…Cendres & Metaux SA · 2011
- Descendant · cites it directly · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
- Descendant · 2 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · 3 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- Descendant · 2 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015
- Descendant · 3 generations on · 38 of its ownK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
Showing 5 of 201 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 201 · See all- K120414Osseospeed PlusAstra Tech AB · 2012 · cites it directly196descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 2 generations on86descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 3 generations on51descendants
- K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 2 generations on42descendants
- K191986DESS Dental Smart SolutionsTerrats Medical SL · 2019 · 3 generations on38descendants
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 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| −1 | K073628 | Synocta Abutments | Straumann USA | 2008 | — |
| 0 (this device) | K111390 | Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 /… | Cendres & Metaux SA | 2011 | — |
| +1 | K120414 | Osseospeed Plus | Astra Tech AB | 2012 | — |
| +2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| +2 | K150295 | LOCATOR RTx | Zest Anchors, Inc. | 2015 | — |
| +3 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2010 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2015 | 6 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 7 | 0 |
| 2019 | 10 | 0 |
| 2020 | 14 | 0 |
| 2021 | 14 | 0 |
| 2022 | 20 | 0 |
| 2023 | 27 | 0 |
| 2024 | 30 | 0 |
| 2025 | 33 | 0 |
| 2026 | 17 | 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 |
|---|---|---|---|
| * | K073628 | Synocta AbutmentsSummary page 1…plant Abutment Regulation Number: 21 CFR 872.3630 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Predicate Device(s): K073628,K1(83876, K102382 Description of the Device Device Description: The SF1-Bar® provides the connection between compatib… | 2008 |
| * | K083876 | Sfi-Bar System Complete 2-Implant and 4-ImplantSummary page 3…redicate Device SFI-Bar® SF-Bar® RN synOcta® 5 10(k) Number K(083876, K073628 K(102382 Design / construction Machined… | 2010 |
| * | K102382 | Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantSummary page 1…ulation Number: 21 CFR 872.3630 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Predicate Device(s): K073628,K1(83876, K102382 Description of the Device Device Description: The SF1-Bar® provides the connection between compatible dental… | 2010 |
What descends from it? (201)
See all 2013 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 21 years and passes through 3 companies; a new generation was cleared every 5.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K120414 (Astra Tech AB, 2012) has gone furthest, with 196 descendants of its own.
- 3 other devices also cite its predicate K073628.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 SF1-Bar® is intended to be used with the implant manufacturer's implant (TABLE a) to provide support for fixation of overentures.
Implant Company — Implant System — Implant Platform Diameter
Institut Straumann — ITI Dental Implant System® — Standard 4.1 and 4.8 mm! / Standard. Plus 4.1 and 4.8 mm! / Tapered Effect 4.1 and 4.8 / Regular Neck (RN) 4.8 mm
Thommen Medical — SPI® Element Platform — 4.0 mm
Neoss — Neoss ProActive Implant — 3.5/4.0 /4.5 /5.0 /5.5 mm
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111390 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111390: Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0, Sfi-Bar (R) Implant Adapter Stra...” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K111390
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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