510(k) · Cleared
ClearedRN Synocta Ucla Gold Abutment for the Straumann Dental Implant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann AG · NHA Abutment, Implant, Dental, Endosseous
Cleared on May 24, 2004 as substantially equivalent to K022859 (Straumann USA, 2002) after a 10-day review. Its family tree reaches back 3 generations to 1990. 368 later devices descend from it.
- Decided
- May 24, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K894844 (1990). 4 ancestors in all. 368 later devices descend from it, 8 citing it directly.
- Root · 3 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 2 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 1 generation backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- This deviceK041295 RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG · 2004
- Descendant · cites it directly · 318 of its ownK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
- Descendant · 2 generations on · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · 3 generations on · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
- Descendant · cites it directly · 225 of its ownK070549 Straumann P.004 RC Gold AbutmentInstitut Straumann AG · 2007
- Descendant · 2 generations on · 224 of its ownK072497 P.004 NC Gold Abutment for CrownsInstitut Straumann AG · 2007
Showing 5 of 368 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 368 · See all- K051717RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005 · cites it directly318descendants
- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · 2 generations on283descendants
- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · 3 generations on279descendants
- K070549Straumann P.004 RC Gold AbutmentInstitut Straumann AG · 2007 · cites it directly225descendants
- K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG · 2007 · 2 generations on224descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −2 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −1 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| 0 (this device) | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental Implant | Institut Straumann AG | 2004 | — |
| +1 | K051717 | RN Synocta Temporary Meso Abutment | Institut Straumann SA | 2005 | — |
| +2 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +3 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
| +1 | K070549 | Straumann P.004 RC Gold Abutment | Institut Straumann AG | 2007 | — |
| +2 | K072497 | P.004 NC Gold Abutment for Crowns | Institut Straumann AG | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 7 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 4 | 0 |
| 2013 | 8 | 0 |
| 2014 | 13 | 0 |
| 2015 | 16 | 0 |
| 2016 | 17 | 0 |
| 2017 | 20 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 31 | 0 |
| 2021 | 33 | 0 |
| 2022 | 28 | 0 |
| 2023 | 47 | 0 |
| 2024 | 45 | 0 |
| 2025 | 34 | 0 |
| 2026 | 20 | 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 |
|---|---|---|---|
| * | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant SystemSummary page 1…eqally Marketed Devices to which Equivalence is Claimed (Predicate Devices) Straumann 1.5mm synOcta Abutment with Gold Coping (K022859) 4. Description of the Device The ITI Dental Implant System is an integrated system of endosseous dental… | 2002 |
What descends from it? (368)
See all 3688 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051717 | RN Synocta Temporary Meso Abutment | 2005 | 318 |
| K070549 | Straumann P.004 RC Gold Abutment | 2007 | 225 |
| K101207 | Neodent Implant System | 2010 | 181 |
| K101945 | Neodent Implant System | 2011 | 180 |
| K071888 | Straumann P.004 RC Gold Abutment for Bridges | 2007 | 1 |
| K151590 | Straumann RN Gold Abutment for Bridge | 2016 | 0 |
| K090081 | Talladium International Implantology Abutments | 2010 | 0 |
| K063789 | WN Synocta Gold Abutment | 2007 | 0 |
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 14 years and passes through 3 companies; a new generation was cleared every 3.2 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K051717 (Institut Straumann SA, 2005) has gone furthest, with 318 descendants of its own.
- 8 other devices also cite its predicate K022859.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 bridges to provide support for prosthetic reconstructions such as crowns or bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041295 · printed Nov 5, 2026
Cite this page
510(k) Report. “K041295: RN Synocta Ucla Gold Abutment for the Straumann Dental Implant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K041295
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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