510(k) Report

510(k) · Cleared

Cleared

SternSnap Angled Attachment

K150250510(k) AbbreviatedCleared Jun 11, 2015128-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

Sterngold Dental, LLC · NHA Abutment, Implant, Dental, Endosseous

Cleared on Jun 11, 2015 as substantially equivalent to K142407 (Sterngold Dental, LLC, 2014) after a 128-day review. Its family tree reaches back 8 generations to 1990.

Decided
Jun 11, 2015
Review
128 days
Class
Class II
Product code
NHA
Recalls
None
Predicates
1

Its longest line of descent runs back 8 generations to K894844 (1990). 24 ancestors in all. No later device cites it as a predicate yet.

  1. Root · 8 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
  2. 7 generations backK990342 Synocta ProstheticsStraumann USA · 1999
  3. 6 generations backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
  4. 5 generations backK041295 RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG · 2004
  5. 4 generations backK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
  6. 3 generations backK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
  7. 2 generations backK130618 Sfi-AnchorCendres & Metaux SA · 2014
  8. 1 generation backK142407 Straight Stud AttachmentSterngold Dental, LLC · 2014
  9. This deviceK150250 SternSnap Angled AttachmentSterngold Dental, LLC · 2015
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K894844Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd.1990—
−7K990342Synocta ProstheticsStraumann USA1999—
−6K022859Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA2002—
−5K041295RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG2004—
−4K051717RN Synocta Temporary Meso AbutmentInstitut Straumann SA2005—
−3K080239P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004…Straumann Manufacturing, Inc.2008—
−2K130618Sfi-AnchorCendres & Metaux SA2014—
−1K142407Straight Stud AttachmentSterngold Dental, LLC2014—
0 (this device)K150250SternSnap Angled AttachmentSterngold Dental, LLC2015—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199220
199310
199410
199520
199620
200020
200810
201020
201110
201310
201410
FIG. 1 — Lineage of K150250, 1990–2015Source: 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K142407Straight Stud Attachment
Summary page 4
…lence is claimed (Predicate Devices): Trade Name 510(k) No. Manufacturer Manufacturer Straight Stud Attachment K142407 Sterngold Dental, LLC Primary Predicate SFI Bar® Implant Abutments K130183 and K132814 Sterngold D…
Sterngold Dental, LLC2014—
†K130183Sfi Bar AbutmentsSterngold Dental, LLC2013—
†K132814Sfi-Bar Implant AbutmentsSterngold Dental, LLC2014—
†K130618Sfi-AnchorCendres & Metaux SA2014—
†K131526Sfi-BarCendres & Metaux SA2013—

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 25 years and passes through 7 companies; a new generation was cleared every 2.8 years on median.
  • 1 of the 24 ancestors has a recall of any class.

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. 2015, 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 SternSnap Angled Attachment is indicated for use with dental implants to support and/or retain removable dental prostheses in the treatment of partially or totally edentulous patients to restore chewing function. The attachment screws into SFI Abutments which are screwed into endosseous implants.

The SternSnap Angled Attachment is compatible with Sterngold SFI Abutments.

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

Cite this page

510(k) Report. “K150250: SternSnap Angled Attachment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150250

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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