510(k) Report

510(k) · Cleared

Cleared

Sfi-Bar

K131526510(k) TraditionalCleared Sep 23, 2013118-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 Sep 23, 2013 as substantially equivalent to K083876 (Cendres & Metaux SA, 2010) and 6 other predicates after a 118-day review. Its family tree reaches back 10 generations to 1996.

Decided
Sep 23, 2013
Review
118 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
7

Its longest line of descent runs back 10 generations to K960026 (1996). 22 ancestors in all, the oldest K894844 (1990). No later device cites it as a predicate yet.

Other ancestors, by year cleared 2011: 1 other ancestor2010: 2 other ancestors2008: 2 other ancestors2007: 1 other ancestor2001: 1 other ancestor2002: 1 other ancestor1999: 2 other ancestors1995: 1 other ancestor1990: 1 other ancestorK960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997×2: 2 generations cleared close together, K020133 (2002), K020645 (2002) K022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK042429 · The Prodigy System Dental Implants · BioHorizons Implant Systems, Inc. · 2004K053152 · Biohorizons Single-Stage Implant · BioHorizons Implant Systems, Inc. · 2005 · recalledK073282 · Biohorizons Single-Stage Implant System · BioHorizons Implant Systems, Inc. · 2008199019952000200520102015
Other ancestors, by generation 1 generation back: 4 other ancestors2 generations back: 3 other ancestors3 generations back: 1 other ancestor4 generations back: 2 other ancestors5 generations back: 2 other ancestors K073282 · Biohorizons Single-Stage Implant System · BioHorizons Implant Systems, Inc. · 2008K053152 · Biohorizons Single-Stage Implant · BioHorizons Implant Systems, Inc. · 2005 · recalledK042429 · The Prodigy System Dental Implants · BioHorizons Implant Systems, Inc. · 2004K030463 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2003 · recalledK022795 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020645 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K020133 · Modification to the Maestro System · BioHorizons Implant Systems, Inc. · 2002K972313 · The Maestro System · BioHorizons Implant Systems, Inc. · 1997K964330 · Biohorizons Dental Implant System (Name Subject to Change) · BioHorizons Implant Systems, Inc. · 1997K960026 · Biohorizons Dental Implant System · BioHorizons Implant Systems, Inc. · 1996−10−50
  1. Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 6 generations between
  3. 3 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
  4. 2 generations backK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · Recalled
  5. 1 generation backK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
  6. This deviceK131526 Sfi-BarCendres & Metaux SA · 2013
Show all 10 generations
  1. Root · 10 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
  2. 9 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
  3. 8 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
  4. 7 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  5. 6 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  6. 5 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
  7. 4 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
  8. 3 generations backK042429 The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc. · 2004
  9. 2 generations backK053152 Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc. · 2005 · Recalled
  10. 1 generation backK073282 Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc. · 2008
  11. This deviceK131526 Sfi-BarCendres & Metaux SA · 2013
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−10K960026Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc.1996—
−9K964330Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc.1997—
−8K972313The Maestro SystemBioHorizons Implant Systems, Inc.1997—
−7K020133Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−6K020645Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−5K022795Modification to the Maestro SystemBioHorizons Implant Systems, Inc.2002—
−4K030463Modification to the Maestro SystemBioHorizons Implant Systems, Inc.20031
−3K042429The Prodigy System Dental ImplantsBioHorizons Implant Systems, Inc.2004—
−2K053152Biohorizons Single-Stage ImplantBioHorizons Implant Systems, Inc.20051
−1K073282Biohorizons Single-Stage Implant SystemBioHorizons Implant Systems, Inc.2008—
0 (this device)K131526Sfi-BarCendres & Metaux SA2013—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199510
199920
200110
200210
200710
200820
201020
201110
FIG. 1 — Lineage of K131526, 1996–2013Source: 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 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. #1 K222288 DESS Dental Smart Solutionsscore 30.6 · 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? (7)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K083876Sfi-Bar System Complete 2-Implant and 4-Implant
Summary page 4
…rmance "Predicate Devices" 510(k) No. Candidate K083876, K<071638, -- K<111390 K<042429…
Cendres & Metaux SA2010—
*K111390Sfi-Bar (R) Implant Adapter Spi (R) Element PF 0 4.0 / H 3.0 / H 4.0 / H 5.0 / H 6.0…
Summary page 3
…"Predicate Devices" 510(k) No. Candidate K(083876, K071638. -- K(111390 K(042429, K(073268,…
Cendres & Metaux SA2011—
*K071638Biohorizons Tapered Internal Implant System
Summary page 3
…"Predicate Devices" 510(k) No. Candidate K(083876, K071638. -- K(111390 K(042429,…
BioHorizons Implant Systems, Inc.20072
*K042429The Prodigy System Dental Implants
Summary page 1
…21 CFR 872.3630 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Predicate Device(s): 1083876. KIt 390,1<071638,1<042429, K073268.K1<53152, K073282 Description of the Devic e Device Description:…
BioHorizons Implant Systems, Inc.2004—
*K073268Biohorizons Internal Implant System
Summary page 1
…21 CFR 872.3630 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Predicate Device(s): 1083876. KIt 390,1<071638,1<042429, K073268.K1<53152, K073282 Description of the Devic e Device Description: The SF…
BioHorizons Implant Systems, Inc.20081
*K053152Biohorizons Single-Stage Implant
Summary page 5
…2429. K073268. 1K0531 52. _____________ K073282 Operating Impression taking;…
BioHorizons Implant Systems, Inc.20051
*K073282Biohorizons Single-Stage Implant System
Summary page 1
…h Equivalence is Claimed (Predicate Device) Predicate Device(s): 1083876. KIt 390,1<071638,1<042429, K073268.K1<53152, K073282 Description of the Devic e Device Description: The SF1-Bar,®R…
BioHorizons Implant Systems, Inc.2008—

Also cleared against K083876: 5 other devices →

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 17 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
  • 4 of the 22 ancestors have a recall of any class.
  • 5 other devices also cite its predicate K083876.

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. 2013, 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 SFI-Bar® is intended to be used with the implant manufacturer's implant (Table 1) to provide support for fixation of overdentures.

Only the implant systems listed in Table 1 may be used with SFI-Bar.

The compatible implant systems are specified in Table 1 below.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K083876

5 other devices cite the same predicate.

  • K130618Sfi-AnchorCendres & Metaux SA · 2014
  • K122988Klockner Dental Implant AbutmentsSoadco, S.L. · 2013
  • K130183Sfi Bar AbutmentsSterngold Dental, LLC · 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

More from Cendres & Metaux SA

6 FDA decisions under this applicant name. See the company

  • K130618Sfi-AnchorCendres & Metaux SA · 2014
  • 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
  • K083876Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA · 2010

Recent decisions in NHA

The NHA category page

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  • K262207Cemented Plus AbutmentUnidental Co., Ltd. · 2026
  • K260940BellaTek BarsZimVie US Corp, LLC · 2026
  • K253999Universal Base ASC Engaging; Universal Base ASC Non-Engaging; Universal Base MUA ASC; Temporary Abutment…Nobel Biocare AB · 2026
  • K261147Neodent Implant System - NeoConvert FitJJGC Indústria e Comércio de Materiais Dentários S.A. · 2026

https://510kreport.com/device/K131526 · printed Nov 6, 2026

Cite this page

510(k) Report. “K131526: Sfi-Bar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131526

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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