510(k) Report

510(k) · Cleared

Cleared

Sfi-Bar System Complete 2-Implant and 4-Implant

K083876510(k) TraditionalCleared Feb 26, 2010424-day reviewClass II21 CFR 872.3630

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Cendres & Metaux SA · NHA Abutment, Implant, Dental, Endosseous

Cleared on Feb 26, 2010 after a 424-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 219 later devices descend from it.

Decided
Feb 26, 2010
Review
424 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
0

219 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2013: 4 descendants cleared2014: 5 descendants cleared2011: 1 descendant cleared2012: 1 descendant cleared2017: 12 descendants cleared2016: 10 descendants cleared2015: 7 descendants cleared2019: 10 descendants cleared2021: 14 descendants cleared2018: 9 descendants cleared2022: 20 descendants cleared2023: 28 descendants cleared2024: 31 descendants cleared2020: 16 descendants cleared2025: 33 descendants cleared2026: 17 descendants cleared2010201520202025
  1. This deviceK083876 Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA · 2010
  2. Descendant · cites it directly · 208 of its ownK102382 Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss…Cendres & Metaux SA · 2010
  3. Descendant · cites it directly · 201 of its ownK111390 Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0…Cendres & Metaux SA · 2011
  4. Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
  5. Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
  6. Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018

Showing 5 of 219 descendants. See all descendants

Descendants cleared per year

2010: 12011: 12012: 12013: 42014: 52015: 72016: 102017: 122018: 92019: 102020: 162021: 142022: 202023: 282024: 312025: 332026: 17
2010high 33 (2025) · low 1 (2010)2026

Most influential descendants

Showing 5 of 219 · See all
  • K102382Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantCendres & Metaux SA · 2010 · cites it directly208descendants
  • K111390Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0…Cendres & Metaux SA · 2011 · cites it directly201descendants
  • K120414Osseospeed PlusAstra Tech AB · 2012 · 2 generations on196descendants
  • K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
  • K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K083876Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA2010—
+1K102382Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantCendres & Metaux SA2010—
+1K111390Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 /…Cendres & Metaux SA2011—
+2K120414Osseospeed PlusAstra Tech AB2012—
+3K170588DESS Dental Smart SolutionsTerrats Medical SL2017—
+4K173908DESS Dental Smart SolutionsTerrats Medical SL2018—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
201110
201210
201340
201450
201570
2016100
2017120
201890
2019100
2020160
2021140
2022200
2023280
2024310
2025330
2026170
FIG. 1 — Lineage of K083876, 2010–2026Source: 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 510(k) statement (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. #1 K222288 DESS Dental Smart Solutionsscore 30.7 · 19 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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (219)

See all 219

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K102382Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantCendres & Metaux SA2010208
K111390Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0…Cendres & Metaux SA2011201
K122988Klockner Dental Implant AbutmentsSoadco, S.L.20139
K130183Sfi Bar AbutmentsSterngold Dental, LLC20137
K130618Sfi-AnchorCendres & Metaux SA20142
K131526Sfi-BarCendres & Metaux SA20130

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, K102382 (Cendres & Metaux SA, 2010) has gone furthest, with 208 descendants of its own.

How does its category compare?

All NHA devices

NHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007: 382008: 312009: 302010: 192011: 312012: 252013: 222014: 272015: 292016: 382017: 312018: 312019: 282020: 382021: 292022: 332023: 512024: 432025: 402026 (partial year): 23
2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007: 91 days median2008: 90 days median2009: 95 days median2010: 162 days median2011: 130 days median2012: 171 days median2013: 184 days median2014: 160 days median2015: 151 days median2016: 202 days median2017: 188 days median2018: 200 days median2019: 160 days median2020: 153 days median2021: 211 days median2022: 142 days median2023: 147 days median2024: 158 days median2025: 147 days median2026 (partial year): 169 days median
2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

2007: 12008: 22011: 52012: 12013: 12015: 12016: 362017: 22018: 12020: 72023: 32025: 12026 (partial year): 3
2007high 36 (2016) · low 0 (2009)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · NHA

838in 2025

2007: 12008: 82009: 302010: 612011: 562012: 52013: 1432014: 1462015: 8582016: 3142017: 5772018: 5912019: 5302020: 4582021: 5462022: 4972023: 6182024: 6352025: 838
2007high 858 (2015) · low 1 (2007)2025

MAUDE reports naming product code NHA, 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
2007389111
2008319028
20093095030
201019162061
201131130556
20122517115
2013221841143
2014271600146
2015291511858
20163820236314
2017311882577
2018312001591
2019281600530
2020381537458
2021292110546
2022331420497
2023511473618
2024431580635
2025401471838
2026231693—

What is it indicated for?

The SF1-Bar is intended to be used with the SPI Element Platform 4.0 mm implant (K070007) to provide support for fixation of overdentures.

The SF1 Bar consists of the following variants:

SF1-Bar 2 Implant:

Lower jaw:

Connecting 2 or 2x2 implants in the intraforaminal region

Upper jaw:

Connecting 2x2 implants in the anterior/premolar region

SF1-Bar 4 Implant:

Lower jaw:

Connecting 4 implants in the intraforaminal region

Upper jaw:

Connecting 4 implants in the anterior/premolar region

Indications for use as stated in the FDA 510(k) statement.

More from Cendres & Metaux SA

6 FDA decisions under this applicant name. See the company

  • K130618Sfi-AnchorCendres & Metaux SA · 2014
  • K131526Sfi-BarCendres & Metaux SA · 2013
  • K123638Pekkton IvoryCendres & Metaux SA · 2013
  • K111390Sfi-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…Cendres & Metaux SA · 2011
  • K102382Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantCendres & Metaux SA · 2010

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https://510kreport.com/device/K083876 · printed Nov 4, 2026

Cite this page

510(k) Report. “K083876: Sfi-Bar System Complete 2-Implant and 4-Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083876

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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