510(k) · Cleared
ClearedStraumann Healing Abutments, Healing Caps, Closure Screws
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Straumann USA · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jun 28, 2013 as substantially equivalent to K111357 (Straumann USA, 2011) and 7 other predicates after a 95-day review. Its family tree reaches back 10 generations to 1990. 39 later devices descend from it.
- Decided
- Jun 28, 2013
- Review
- 95 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 8
Its longest line of descent runs back 10 generations to K894595 (1990). 65 ancestors in all, the oldest K894844 (1990). 39 later devices descend from it, 5 citing it directly.
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 6 generations between
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- This deviceK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
- Descendant · cites it directly · 30 of its ownK163194 Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · Recalled
- Descendant · 2 generations on · 7 of its ownK200992 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · 3 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · cites it directly · 5 of its ownK162890 BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and…Straumann USA, LLC · 2017
- Descendant · 4 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
Show all 10 generations
- Root · 10 generations backK894595 Bonefit R Screw ImplantsInstitut Straumann AG · 1990
- 9 generations backK984104 Iti Dental Implant SystemStraumann USA · 1999 · Recalled
- 8 generations backK992937 Dental ImplantNobel Biocare Uas, Inc. · 2000 · Recalled
- 7 generations backK013067 Frialoc Dental Implant SystemFriadent GmbH · 2002
- 6 generations backK021318 Xive Dental Implant SystemFriadent GmbH · 2002
- 5 generations backK032158 Xive Dental Implant System MultipleFriadent GmbH · 2003
- 4 generations backK033984 Straumann Dental Implant SystemInstitut Straumann AG · 2004
- 3 generations backK053088 Slactive ImplantsInstitut Straumann AG · 2006
- 2 generations backK060958 Straumann Narrow Neck ImplantsStraumann USA · 2006
- 1 generation backK111357 Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemStraumann USA · 2011
- This deviceK130808 Straumann Healing Abutments, Healing Caps, Closure ScrewsStraumann USA · 2013
Showing 5 of 39 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 39 · See all- K163194Neodent Implant System - GM LineJjgc Industria E Comercio DE Materiais Dentarios S.A. · 2017 · cites it directly30descendants
- K200992S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · 2 generations on7descendants
- K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 3 generations on5descendants
- K162890BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC…Straumann USA, LLC · 2017 · cites it directly5descendants
- K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 4 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K894595 | Bonefit R Screw Implants | Institut Straumann AG | 1990 | — |
| −9 | K984104 | Iti Dental Implant System | Straumann USA | 1999 | 1 |
| −8 | K992937 | Dental Implant | Nobel Biocare Uas, Inc. | 2000 | 1 |
| −7 | K013067 | Frialoc Dental Implant System | Friadent GmbH | 2002 | — |
| −6 | K021318 | Xive Dental Implant System | Friadent GmbH | 2002 | — |
| −5 | K032158 | Xive Dental Implant System Multiple | Friadent GmbH | 2003 | — |
| −4 | K033984 | Straumann Dental Implant System | Institut Straumann AG | 2004 | — |
| −3 | K053088 | Slactive Implants | Institut Straumann AG | 2006 | — |
| −2 | K060958 | Straumann Narrow Neck Implants | Straumann USA | 2006 | — |
| −1 | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant System | Straumann USA | 2011 | — |
| 0 (this device) | K130808 | Straumann Healing Abutments, Healing Caps, Closure Screws | Straumann USA | 2013 | — |
| +1 | K163194 | Neodent Implant System - GM Line | Jjgc Industria E Comercio DE Materiais Dentarios S.A. | 2017 | 6 |
| +2 | K200992 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +3 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +1 | K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing… | Straumann USA, LLC | 2017 | — |
| +4 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 3 | 0 |
| 1994 | 3 | 0 |
| 1995 | 1 | 0 |
| 1996 | 7 | 0 |
| 1997 | 1 | 0 |
| 1998 | 4 | 0 |
| 1999 | 4 | 0 |
| 2000 | 2 | 0 |
| 2001 | 6 | 0 |
| 2002 | 5 | 0 |
| 2003 | 6 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 5 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 5 | 0 |
| 2021 | 5 | 0 |
| 2022 | 2 | 0 |
| 2023 | 5 | 0 |
| 2024 | 3 | 0 |
| 2025 | 6 | 0 |
| 2026 | 4 | 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? (8)
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 |
|---|---|---|---|
| * | K111357 | Straumann Narrow Neck Crossfit (NNC) 03.3MM Dental Implant SystemSummary page 1…A Classification Name: Endosseous Dental Implant Abutments Regulation Number: §872.3630 Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) _ K111357, Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant . System K072679, P.004 Abutments KO071585, P.004 Healing Abutments… | 2011 |
| * | K072679 | P.004 AbutmentsSummary page 1…§872.3630 Legally Marketed Devices to which Equivalence is Claimed (Predicate Devices) _ K111357, Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant . System K072679, P.004 Abutments KO071585, P.004 Healing Abutments and Closure Screws KQ70478, P.004 RC Temporary Abutment, P.004 Temporary Hea… | 2007 |
| * | K071585 | P.004 Healing Abutments and Closure ScrewsSummary page 1…Devices to which Equivalence is Claimed (Predicate Devices) _ K111357, Straumann Narrow Neck CrossFit (NNC) 03.3mm Dental Implant . System K072679, P.004 Abutments KO071585, P.004 Healing Abutments and Closure Screws KQ70478, P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) K062129… | 2007 |
| * | K070478 | P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) | 2007 |
| * | K062129 | P.0004 ImplantsSummary page 1…nt . System K072679, P.004 Abutments KO071585, P.004 Healing Abutments and Closure Screws KQ70478, P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) K062129, P.004 implants K013798, Prosthetic Accessories to the ITI Dental Implant System K960634, Titanium Healing Caps K894844, BoneFit… | 2006 |
| * | K013798 | Prosthetic Accessories to the Iti Dental Implant SystemSummary page 1…04 Abutments KO071585, P.004 Healing Abutments and Closure Screws KQ70478, P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) K062129, P.004 implants K013798, Prosthetic Accessories to the ITI Dental Implant System K960634, Titanium Healing Caps K894844, BoneFit Implant System Accessori… | 2001 |
| * | K960634 | Titanium Healing CapsSummary page 1…s KQ70478, P.004 RC Temporary Abutment, P.004 Temporary Healing Abutment (Cap) K062129, P.004 implants K013798, Prosthetic Accessories to the ITI Dental Implant System K960634, Titanium Healing Caps K894844, BoneFit Implant System Accessories and Instruments . Description of the Device The Straumann He… | 1996 |
| * | K894844 | Bonefit Implant System Accessories & InstrumentsSummary page 1…Abutment, P.004 Temporary Healing Abutment (Cap) K062129, P.004 implants K013798, Prosthetic Accessories to the ITI Dental Implant System K960634, Titanium Healing Caps K894844, BoneFit Implant System Accessories and Instruments . Description of the Device The Straumann Healing Abutments, Healing Caps,… | 1990 |
What descends from it? (39)
See all 395 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K163194 | Neodent Implant System - GM Line | 2017 | 30 |
| K162890 | BLT 02.9mm SC, SLA or SLActive, RXD, Loxim, SC Closure Cap and Healing Abutments, SC… | 2017 | 5 |
| K241575 | Straumann® Anatomic Healing Abutments XC (AHA) | 2024 | 0 |
| K161677 | Straumann Sterile Healing Solution | 2016 | 0 |
| K142557 | Anker Dental Implant System - SB-III, ST and AT series | 2015 | 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 23 years and passes through 4 companies; a new generation was cleared every 1.7 years on median.
- 6 of the 65 ancestors have a recall of any class.
- Of its descendants, K163194 (Jjgc Industria E Comercio DE Materiais Dentarios S.A., 2017) has gone furthest, with 30 descendants of its own.
- 7 other devices also cite its predicate K111357.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Closure Screws, healing caps, and healing abutments, 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.
Customizable healing abutments made of PEEK are for use for up to six months.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K130808 · printed Nov 6, 2026
Cite this page
510(k) Report. “K130808: Straumann Healing Abutments, Healing Caps, Closure Screws.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K130808
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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