510(k) · Cleared

Cleared

Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant

K102382510(k) SpecialCleared Dec 3, 2010102-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 Dec 3, 2010 as substantially equivalent to K083876 (Cendres & Metaux SA, 2010) after a 102-day review. Its family tree reaches back 1 generation to 2010. 208 later devices descend from it.

Decided: Dec 3, 2010
Review: 102 days
Class: Class II
Product code: NHA
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K083876 (2010). 208 later devices descend from it, 4 citing it directly.

By dateBy generation

Root · 1 generation backK083876 Sfi-Bar System Complete 2-Implant and 4-ImplantCendres & Metaux SA · 2010
This deviceK102382 Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss…Cendres & Metaux SA · 2010
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
Descendant · 2 generations on · 196 of its ownK120414 Osseospeed PlusAstra Tech AB · 2012
Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Descendant · 3 generations on · 42 of its ownK150295 LOCATOR RTxZest Anchors, Inc. · 2015

Showing 5 of 208 descendants. See all descendants

Descendants cleared per year

2011high 33 (2025) · low 1 (2011)2026

Most influential descendants

Showing 5 of 208 · See all

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
K150295LOCATOR RTxZest Anchors, Inc. · 2015 · 3 generations on42descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K083876	Sfi-Bar System Complete 2-Implant and 4-Implant	Cendres & Metaux SA	2010	—
0 (this device)	K102382	Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant	Cendres & Metaux SA	2010	—
+1	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	—
+2	K120414	Osseospeed Plus	Astra Tech AB	2012	—
+3	K170588	DESS Dental Smart Solutions	Terrats Medical SL	2017	—
+4	K173908	DESS Dental Smart Solutions	Terrats Medical SL	2018	—
+3	K150295	LOCATOR RTx	Zest Anchors, Inc.	2015	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2012	1	0
2013	3	0
2014	5	0
2015	7	0
2016	8	0
2017	10	0
2018	8	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

FIG. 1 — Lineage of K102382, 2010–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (1)

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	Applicant	Decided	Recalls
*	K083876	Sfi-Bar System Complete 2-Implant and 4-Implant Summary page 1 …plant Abutment Regulation Number: 21 CFR 872.3630 Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Predicate Device(s): K083876 Description of the Device Device Description: The SF1-Bar® provides the connection between compatible dental…	Cendres & Metaux SA	2010	—

Also cleared against K083876: 5 other devices →

What descends from it? (208)

See all 208

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

Number	Device	Applicant	Decided	Descendants
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…	Cendres & Metaux SA	2011	201
K130183	Sfi Bar Abutments	Sterngold Dental, LLC	2013	7
K132814	Sfi-Bar Implant Abutments	Sterngold Dental, LLC	2014	6
K130618	Sfi-Anchor	Cendres & Metaux SA	2014	2

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?

Its one ancestor has no recall.
Of its descendants, K111390 (Cendres & Metaux SA, 2011) has gone furthest, with 201 descendants of its own.
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. 2010, this device’s year, is highlighted.

FDA decisions per year · NHA

40in 2025

2007high 51 (2023) · low 19 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · NHA

147in 2025

2007high 211 (2021) · low 90 (2008)2026

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

Recalls per year · NHA

1in 2025

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

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

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 (Table 1) implant to provide support for fixation of overdentures.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K102382 · printed Nov 6, 2026

Cite this page

510(k) Report. “K102382: Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102382

Report an extraction error

Are you the manufacturer?

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