510(k) · Cleared
ClearedP.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings
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 Apr 30, 2008 as substantially equivalent to K894844 (Straumann Institute, Ltd., 1990) and 5 other predicates after a 90-day review. Its family tree reaches back 5 generations to 1990. 164 later devices descend from it.
- Decided
- Apr 30, 2008
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 5 generations to K894844 (1990). 13 ancestors in all. 164 later devices descend from it, 4 citing it directly.
- Root · 5 generations backK894844 Bonefit Implant System Accessories & InstrumentsStraumann Institute, Ltd. · 1990
- 4 generations backK990342 Synocta ProstheticsStraumann USA · 1999
- 3 generations backK022859 Abutment and Prosthetic Accessories to the Iti Dental Implant SystemStraumann USA · 2002
- 2 generations backK041295 RN Synocta Ucla Gold Abutment for the Straumann Dental ImplantInstitut Straumann AG · 2004
- 1 generation backK051717 RN Synocta Temporary Meso AbutmentInstitut Straumann SA · 2005
- This deviceK080239 P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps…Straumann Manufacturing, Inc. · 2008
- Descendant · cites it directly · 115 of its ownK133421 Straumann Magellan (TM) Abutment,Protective Cap,Titanium…Straumann USA, LLC · 2014
- Descendant · 2 generations on · 89 of its ownK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- Descendant · 3 generations on · 86 of its ownK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- Descendant · cites it directly · 64 of its ownK111935 TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012
- Descendant · 4 generations on · 51 of its ownK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
Showing 5 of 164 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 164 · See all- K133421Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold Chopings,Basal ScrewStraumann USA, LLC · 2014 · cites it directly115descendants
- K150367Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015 · 2 generations on89descendants
- K170588DESS Dental Smart SolutionsTerrats Medical SL · 2017 · 3 generations on86descendants
- K111935TI-Base Abutment, 1 Connect AbutmentNt-Trading GmbH and CO KG · 2012 · cites it directly64descendants
- K173908DESS Dental Smart SolutionsTerrats Medical SL · 2018 · 4 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894844 | Bonefit Implant System Accessories & Instruments | Straumann Institute, Ltd. | 1990 | — |
| −4 | K990342 | Synocta Prosthetics | Straumann USA | 1999 | — |
| −3 | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant System | Straumann USA | 2002 | — |
| −2 | 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 | — |
| 0 (this device) | K080239 | P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004… | Straumann Manufacturing, Inc. | 2008 | — |
| +1 | K133421 | Straumann Magellan (TM) Abutment,Protective Cap,Titanium Copings,Gold… | Straumann USA, LLC | 2014 | — |
| +2 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| +3 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| +1 | K111935 | TI-Base Abutment, 1 Connect Abutment | Nt-Trading GmbH and CO KG | 2012 | — |
| +4 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 2 | 0 |
| 1993 | 1 | 0 |
| 1995 | 2 | 0 |
| 1996 | 2 | 0 |
| 2000 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 7 | 0 |
| 2015 | 8 | 0 |
| 2016 | 7 | 0 |
| 2017 | 9 | 0 |
| 2018 | 8 | 0 |
| 2019 | 6 | 0 |
| 2020 | 9 | 0 |
| 2021 | 17 | 0 |
| 2022 | 16 | 0 |
| 2023 | 19 | 0 |
| 2024 | 19 | 0 |
| 2025 | 24 | 0 |
| 2026 | 13 | 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? (6)
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 |
|---|---|---|---|
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…egulation Number: 21 CFR 872.3630 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717… | 1990 |
| * | K994119 | Synocta Angled AbutmentsSummary page 1…3630 3. Legally Marketed Device to which Equivalence is Claimed (Predicate Device) Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridge… | 2000 |
| * | K962023 | Plastic Protection Healing CapsSummary page 1…e Device) Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta… | 1996 |
| * | K051717 | RN Synocta Temporary Meso AbutmentSummary page 1…Device) Straumann Octa Abutment, K894844 Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta® Titaniu… | 2005 |
| * | K022859 | Abutment and Prosthetic Accessories to the Iti Dental Implant SystemSummary page 1…Straumann synOcta Abutment, K994119 Temporary Copings, K894844 ITI Protective Healing Caps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta® Titanium Copings for Bars, K990342 4. Description of th… | 2002 |
| * | K990342 | Synocta ProstheticsSummary page 1…ps, K962023, K051717 RN synOcta® Gold Copings for Bridges, K022859 RN synOcta® Gold Copings for Bars, K894844 RN synOcta® Titanium Copings for Bars, K990342 4. Description of the Device The Straumann P.004 Dental Implant System is an integrated system of endosseous d… | 1999 |
What descends from it? (164)
See all 1644 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 18 years and passes through 5 companies; a new generation was cleared every 2.8 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K133421 (Straumann USA, LLC, 2014) has gone furthest, with 115 descendants of its own.
- 7 other devices also cite its predicate K894844.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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. The subject abutments are for permanent screw-retained bridges and bar-retained implant-borne dentures.
Protective Caps are intended to protect the outer configuration of the abutment and to maintain and condition the contours of the soft tissue during the healing phase for up to 6 months.
Copings are intended to serve as a base for multi-unit bar or bridge restorations.
Temporary Copings are intended to serve as a base for temporary restorations for up to 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080239 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080239: P.004 Abutments, P.004 Temporary Copings, P.004 Protective Caps, P.004 Permanent Copings.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080239
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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