510(k) · Cleared
ClearedSfi-Anchor
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 Mar 3, 2014 as substantially equivalent to K111390 (Cendres & Metaux SA, 2011) and 4 other predicates after a 361-day review. Its family tree reaches back 6 generations to 1990. 2 later devices descend from it.
- Decided
- Mar 3, 2014
- Review
- 361 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 6 generations to K894844 (1990). 20 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 4 generations backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- 3 generations backK041295 RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG · 2004
- 2 generations backK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
- 1 generation backK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
- This deviceK130618 Sfi-AnchorCendres & Metaux SA · 2014
- Descendant · cites it directly · 1 of its ownK142407 Straight Stud AttachmentSterngold Dental, LLC · 2014
- Descendant · 2 generations on · 0 of its ownK150250 SternSnap Angled AttachmentSterngold Dental, LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −5 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −4 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| −3 | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental Implant | Institut Straumann AG | 2004 | — |
| −2 | K051717 | RN Synocta Temporary Meso Abutment | Institut Straumann SA | 2005 | — |
| −1 | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004… | Straumann Manufacturing, Inc. | 2008 | — |
| 0 (this device) | K130618 | Sfi-Anchor | Cendres & Metaux SA | 2014 | — |
| +1 | K142407 | Straight Stud Attachment | Sterngold Dental, LLC | 2014 | — |
| +2 | K150250 | SternSnap Angled Attachment | Sterngold Dental, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 2 | 0 |
| 2008 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 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? (5)
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 |
|---|---|---|---|
| * | 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…Summary page 1…Claimed (Predicate Device) Trade Name 510(k) no SFI-Bar® K111390, K102382, K083876 Locator Implant Anchor K994257 P.004 RC/NC Bar and Bridge Abutments… | 2011 |
| * | K102382 | Sfi-Bar Implant Adapter Straumann, Sfi-Bar Implant Adapter for Neoss ImplantSummary page 1…(Predicate Device) Trade Name 510(k) no SFI-Bar® K111390, K102382, K083876 Locator Implant Anchor K994257 P.004 RC/NC Bar and Bridge Abutments Line… | 2010 |
| * | K083876 | Sfi-Bar System Complete 2-Implant and 4-ImplantSummary page 1…e Device) Trade Name 510(k) no SFI-Bar® K111390, K102382, K083876 Locator Implant Anchor K994257 P.004 RC/NC Bar and Bridge Abutments Line… | 2010 |
| * | K994257 | Locator Implant AnchorSummary page 1…510(k) no SFI-Bar® K111390, K102382, K083876 Locator Implant Anchor K994257 P.004 RC/NC Bar and Bridge Abutments Line K080239 Figure 1 Predicate Devices Description of the Device D… | 2000 |
| * | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent CopingsSummary page 1…K111390, K102382, K083876 Locator Implant Anchor K994257 P.004 RC/NC Bar and Bridge Abutments Line K080239 Figure 1 Predicate Devices Description of the Device Device Description: The SF1-Anchor® D20 is an endosseous dental implant abu… | 2008 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K142407 | Straight Stud Attachment | 2014 | 1 |
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 24 years and passes through 6 companies; a new generation was cleared every 3.2 years on median.
- 1 of the 20 ancestors has a recall of any class.
- Of its descendants, K142407 (Sterngold Dental, LLC, 2014) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K111390.
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 SF1-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants. The compatible implant systems are specified in Table 1 below. Implant Manufacturer: Institut Straumann Implant System: ITI Dental Implant System® respectively Straumann® Dental Implant System Implant line name(s): see below -Standard 0 4.1 mm Regular Neck (RN) -Standard 0 4.8 mm Regular Neck (RN) -Standard Plus 0 4.1 mm Regular Neck (RN) -Standard…
Read the full statement (121 words)
The SF1-Anchor® D20 is intended for the fixation of (dental) prostheses to corresponding dental implants.
The compatible implant systems are specified in Table 1 below.
Implant Manufacturer: Institut Straumann
Implant System: ITI Dental Implant System® respectively Straumann® Dental Implant System
Implant line name(s): see below
-Standard 0 4.1 mm Regular Neck (RN) -Standard 0 4.8 mm Regular Neck (RN)
-Standard Plus 0 4.1 mm Regular Neck (RN) -Standard Plus 0 4.8 mm Regular Neck (RN)
-Tapered Effect 0 4.1 mm Regular Neck (RN) -Bone Level 0 4.1 mm. Regular CrossFit® (RC)
-Bone Level 0 4.8 mm, Regular CrossFit® (RC)
Table 1 Compatible Implant Systems
The SF1-Anchor® CD20 is intended as an additional retaining element on CAD / CAM milled dental bars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130618 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130618: Sfi-Anchor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130618
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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