510(k) · Cleared
ClearedStraumann P.004 RC Gold Abutment
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 Aug 31, 2007 as substantially equivalent to K062129 (Institut Straumann AG, 2006) and 1 other predicate after a 186-day review. Its family tree reaches back 6 generations to 1990. 225 later devices descend from it.
- Decided
- Aug 31, 2007
- Review
- 186 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894844 (1990). 11 ancestors in all. 225 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 5 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 4 generations backK013798 Prosthetic Accessories to the Iti Dental Implant SystemInstitut Straumann AG · 2001
- 3 generations backK020096 Esthetic Ease Abutments for the Iti Dental Implant SystemInstitut Straumann AG · 2002 · Recalled
- 2 generations backK033243 Iti Synocta Meso AbutmentsStraumann USA · 2003
- 1 generation backK062129 P.0004 ImplantsInstitut Straumann AG · 2006
- This deviceK070549 Straumann P.004 RC Gold AbutmentInstitut Straumann AG · 2007
- Descendant · cites it directly · 224 of its ownK072497 P.004 NC Gold Abutment for CrownsInstitut Straumann AG · 2007
- Descendant · 2 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 3 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · 4 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
- Descendant · 5 generations on · 129 of its ownK150203 Medentika CAD/CAM AbutmentsMedentika GmbH · 2015
Showing 5 of 225 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 225 · See all- K072497P.004 NC Gold Abutment for CrownsInstitut Straumann AG · 2007 · cites it directly224descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 2 generations on222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 3 generations on166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 4 generations on165descendants
- K150203Medentika CAD/CAM AbutmentsMedentika GmbH · 2015 · 5 generations on129descendants
View 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 | K013798 | Prosthetic Accessories to the Iti Dental Implant System | Institut Straumann AG | 2001 | — |
| −3 | K020096 | Esthetic Ease Abutments for the Iti Dental Implant System | Institut Straumann AG | 2002 | 1 |
| −2 | K033243 | Iti Synocta Meso Abutments | Straumann USA | 2003 | — |
| −1 | K062129 | P.0004 Implants | Institut Straumann AG | 2006 | — |
| 0 (this device) | K070549 | Straumann P.004 RC Gold Abutment | Institut Straumann AG | 2007 | — |
| +1 | K072497 | P.004 NC Gold Abutment for Crowns | Institut Straumann AG | 2007 | — |
| +2 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +3 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +4 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
| +5 | K150203 | Medentika CAD/CAM Abutments | Medentika GmbH | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 10 | 0 |
| 2016 | 7 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 11 | 0 |
| 2020 | 19 | 0 |
| 2021 | 24 | 0 |
| 2022 | 16 | 0 |
| 2023 | 29 | 0 |
| 2024 | 30 | 0 |
| 2025 | 27 | 0 |
| 2026 | 16 | 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? (2)
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 |
|---|---|---|---|
| * | K062129 | P.0004 ImplantsSummary page 1…21 CFR 872.3640 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann P.004 Dental Implants, K062129 synOcta Gold Abutment, K041295 4. Description of the Device The Straumann P.004 Dental Implant System is… | 2006 |
| * | K041295 | RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantSummary page 1…Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann P.004 Dental Implants, K062129 synOcta Gold Abutment, K041295 4. Description of the Device The Straumann P.004 Dental Implant System is an integrated system of endoss… | 2004 |
What descends from it? (225)
See all 2252 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 2.4 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K072497 (Institut Straumann AG, 2007) has gone furthest, with 224 descendants of its own.
- 30 other devices also cite its predicate K062129.
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, bridges and overdentures.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070549: Straumann P.004 RC 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/K070549
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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