510(k) · Cleared
ClearedWN Synocta Gold Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 10, 2007 as substantially equivalent to K041295 (Institut Straumann AG, 2004) after a 140-day review. Its family tree reaches back 4 generations to 1990.
- Decided
- May 10, 2007
- Review
- 140 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K894844 (1990). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 3 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 2 generations backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- 1 generation backK041295 RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG · 2004
- This deviceK063789 WN Synocta Gold AbutmentStraumann USA · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −3 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −2 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| −1 | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental Implant | Institut Straumann AG | 2004 | — |
| 0 (this device) | K063789 | WN Synocta Gold Abutment | Straumann USA | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 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? (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 | Decided |
|---|---|---|---|
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 1…21 CFR 872.3640 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) synOcta Gold Abutment, K041295 4. Description of the Device The Straumann Dental Implant System is an integrated system of endosseous dent… | 2004 |
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 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 5 ancestors has a recall.
- 7 other devices also cite its predicate K041295.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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?
Abutments are intended to be placed into dental implants to provide support for prosthetic reconstructions such as crowns and bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063789: WN Synocta Gold Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063789
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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