510(k) · Cleared
ClearedStraumann CI RD Ceramic Healing Caps
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 Jun 28, 2019 as substantially equivalent to K180477 (Institut Straumann AG, 2019) after a 106-day review. Its family tree reaches back 7 generations to 2002. 2 later devices descend from it.
- Decided
- Jun 28, 2019
- Review
- 106 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K022562 (2002). 11 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backK022562 Various Branemark System Implants-Immediate Function IndicationNobel Biocare AB · 2002
- 6 generations backK061971 Zirconia ImplantNobel Biocare AB · 2007
- 5 generations backK093595 Ceraroot Implant SystemOral Iceberg S.L. · 2011
- 4 generations backK120793 Z-LOOK3 Evo SLMZ-Systems AG · 2012
- 3 generations backK151328 PURE Ceramic ImplantsStraumann USA · 2016
- 2 generations backK171769 Straumann PURE Ceramic ImplantsStraumann USA, LLC (On Behalf of Institut Straumann Ag) · 2017
- 1 generation backK180477 Straumann PURE Ceramic Implant SystemInstitut Straumann AG · 2019
- This deviceK190654 Straumann CI RD Ceramic Healing CapsInstitut Straumann AG · 2019
- Descendant · cites it directly · 1 of its ownK192893 Straumann Ceramic Healing AbutmentsInstitut Straumann AG · 2020
- Descendant · 2 generations on · 0 of its ownK232383 iPhysio® SystemEuroteknika · 2025
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K022562 | Various Branemark System Implants-Immediate Function Indication | Nobel Biocare AB | 2002 | — |
| −6 | K061971 | Zirconia Implant | Nobel Biocare AB | 2007 | — |
| −5 | K093595 | Ceraroot Implant System | Oral Iceberg S.L. | 2011 | — |
| −4 | K120793 | Z-LOOK3 Evo SLM | Z-Systems AG | 2012 | — |
| −3 | K151328 | PURE Ceramic Implants | Straumann USA | 2016 | — |
| −2 | K171769 | Straumann PURE Ceramic Implants | Straumann USA, LLC (On Behalf of Institut Straumann Ag) | 2017 | — |
| −1 | K180477 | Straumann PURE Ceramic Implant System | Institut Straumann AG | 2019 | — |
| 0 (this device) | K190654 | Straumann CI RD Ceramic Healing Caps | Institut Straumann AG | 2019 | — |
| +1 | K192893 | Straumann Ceramic Healing Abutments | Institut Straumann AG | 2020 | — |
| +2 | K232383 | iPhysio® System | Euroteknika | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2025 | 1 | 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? (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 |
|---|---|---|---|
| * | K180477 | Straumann PURE Ceramic Implant SystemSummary page 4…Dental Implant Abutment (21 CFR 872.3630) Regulatory Class: II Product Code: NHA Review Panel: Dental 1.3 Predicate Device Primary Predicate: K180477 – Straumann PURE Ceramic Implant System Reference Device: K130808 – Straumann Healing Abutments, Healing Caps, Closure Screws… | 2019 |
| † | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K192893 | Straumann Ceramic Healing Abutments | 2020 | 1 |
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 6 companies; a new generation was cleared every 2.0 years on median.
- None of the 11 ancestors has a recall.
- Of its descendants, K192893 (Institut Straumann AG, 2020) has gone furthest, with 1 descendant of its own.
- 2 other devices also cite its predicate K180477.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Healing Caps are intended for use with the Straumann Dental Implant System (SDIS) to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. Healing Caps should be used only with suitable implant connections. The healing components are intended to be used up to 6 months.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190654 · printed Nov 4, 2026
Cite this page
510(k) Report. “K190654: Straumann CI RD Ceramic Healing Caps.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K190654
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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