510(k) · Cleared
ClearedRN Synocta Temporary Meso Abutment
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Institut Straumann SA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 7, 2005 as substantially equivalent to K990342 (Straumann USA, 1999) and 2 other predicates after a 10-day review. Its family tree reaches back 4 generations to 1990. 318 later devices descend from it.
- Decided
- Jul 7, 2005
- Review
- 10 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K894844 (1990). 8 ancestors in all. 318 later devices descend from it, 5 citing it directly.
- 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 deviceK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
- Descendant · cites it directly · 283 of its ownK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · 2 generations on · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
- Descendant · 3 generations on · 223 of its ownK092814 Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009
- Descendant · 4 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 5 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
Showing 5 of 318 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 318 · See all- K070478P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007 · cites it directly283descendants
- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · 2 generations on279descendants
- K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009 · 3 generations on223descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 4 generations on222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 5 generations on166descendants
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) | K051717 | RN Synocta Temporary Meso Abutment | Institut Straumann SA | 2005 | — |
| +1 | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +2 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
| +3 | K092814 | Straumann Dental Abutments | Straumann Manufacturing, Inc. | 2009 | — |
| +4 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +5 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 4 | 0 |
| 2013 | 7 | 0 |
| 2014 | 10 | 0 |
| 2015 | 13 | 0 |
| 2016 | 15 | 0 |
| 2017 | 19 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 26 | 0 |
| 2021 | 28 | 0 |
| 2022 | 24 | 0 |
| 2023 | 43 | 0 |
| 2024 | 43 | 0 |
| 2025 | 29 | 0 |
| 2026 | 19 | 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? (3)
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 |
|---|---|---|---|
| * | K990342 | Synocta ProstheticsSummary page 1…nt 3. Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) synOcta Post for Temporary Restoration, K990342 RN synOcta UCLA gold Abutment, K041295 ITI Protection Healing Caps, K962023 4. Description of the Device… | 1999 |
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 1…to which Equivalence is Claimed (Predicate Devices) synOcta Post for Temporary Restoration, K990342 RN synOcta UCLA gold Abutment, K041295 ITI Protection Healing Caps, K962023 4. Description of the Device RN synOcta Temporary Meso Abutment is a t… | 2004 |
| * | K962023 | Plastic Protection Healing CapsSummary page 1…(Predicate Devices) synOcta Post for Temporary Restoration, K990342 RN synOcta UCLA gold Abutment, K041295 ITI Protection Healing Caps, K962023 4. Description of the Device RN synOcta Temporary Meso Abutment is a temporary abutment made of medical gra… | 1996 |
What descends from it? (318)
See all 3185 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | 2007 | 283 |
| K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings | 2008 | 164 |
| K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary… | 2012 | 1 |
| K053099 | Biohorizons Plastic Temporary Abutments | 2006 | 1 |
| K070744 | Narrow Neck Temporary Coping | 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 15 years and passes through 4 companies; a new generation was cleared every 3.2 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070478 (Straumann Manufacturing, Inc., 2007) has gone furthest, with 283 descendants of its own.
- 13 other devices also cite its predicate K990342.
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?
RN SynOcta Temporary Meso Abutments are for use in RN Straumann Dental Implants (04.8mm) for temporary restoration of single crowns in the anterior and posterior region for use up to six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051717: RN Synocta Temporary Meso Abutment.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051717
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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