510(k) · Cleared
ClearedP.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann Manufacturing, Inc. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Sep 20, 2007 as substantially equivalent to K062129 (Institut Straumann AG, 2006) and 1 other predicate after a 212-day review. Its family tree reaches back 6 generations to 1990. 283 later devices descend from it.
- Decided
- Sep 20, 2007
- Review
- 212 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K894844 (1990). 15 ancestors in all. 283 later devices descend from it, 4 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 deviceK070478 P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap)Straumann Manufacturing, Inc. · 2007
- Descendant · cites it directly · 279 of its ownK072679 P.004 AbutmentsInstitut Straumann AG · 2007
- Descendant · 2 generations on · 223 of its ownK092814 Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009
- Descendant · 3 generations on · 222 of its ownK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- Descendant · 4 generations on · 166 of its ownK113283 NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree…Straumann USA · 2011
- Descendant · 5 generations on · 165 of its ownK120822 Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase…Institut Straumann AG · 2012
Showing 5 of 283 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 283 · See all- K072679P.004 AbutmentsInstitut Straumann AG · 2007 · cites it directly279descendants
- K092814Straumann Dental AbutmentsStraumann Manufacturing, Inc. · 2009 · 2 generations on223descendants
- K111357Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011 · 3 generations on222descendants
- K113283NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle, Type B,NNC…Straumann USA · 2011 · 4 generations on166descendants
- K120822Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN, Straumann…Institut Straumann AG · 2012 · 5 generations on165descendants
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) | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | Straumann Manufacturing, Inc. | 2007 | — |
| +1 | K072679 | P.004 Abutments | Institut Straumann AG | 2007 | — |
| +2 | K092814 | Straumann Dental Abutments | Straumann Manufacturing, Inc. | 2009 | — |
| +3 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| +4 | K113283 | NNC Cementable Abutment Straight,15 Degree Angle, Type a ,15 Degree Angle… | Straumann USA | 2011 | — |
| +5 | K120822 | Straumann Cares Variobase Abutment NNC, Straumann Cares Variobase Abutment RN… | Institut Straumann AG | 2012 | — |
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 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 5 | 0 |
| 2014 | 5 | 0 |
| 2015 | 10 | 0 |
| 2016 | 11 | 0 |
| 2017 | 16 | 0 |
| 2018 | 16 | 0 |
| 2019 | 13 | 0 |
| 2020 | 23 | 0 |
| 2021 | 26 | 0 |
| 2022 | 20 | 0 |
| 2023 | 40 | 0 |
| 2024 | 42 | 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 30.7 · 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® Temporary Meso Abutment, K051717 P.004 RC Meso Abutment, K062129 4. Description of the Device… | 2006 |
| * | K051717 | RN Synocta Temporary Meso AbutmentSummary page 1…Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann P.004 Dental Implants, K062129 synOcta® Temporary Meso Abutment, K051717 P.004 RC Meso Abutment, K062129 4. Description of the Device The Straumann P.004 Dental Implant System i… | 2005 |
What descends from it? (283)
See all 2834 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 4 companies; a new generation was cleared every 2.4 years on median.
- 1 of the 15 ancestors has a recall of any class.
- Of its descendants, K072679 (Institut Straumann AG, 2007) has gone furthest, with 279 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?
P.004 RC Temporary Abutment is indicated for use in Straumann P.004 RC Bone Level implants for temporary restorations of single crowns and bridges for up to six months.
P.004 Healing Abutment, customizable (cap) is indicated for use in Straumann P.004 RC Bone Level implants to protect the inner configuration of the implant during the healing process. Maintains, stabilizes and forms the soft tissue and should be placed out of occlusion for up to six months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070478 · printed Nov 3, 2026
Cite this page
510(k) Report. “K070478: P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K070478
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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