510(k) · Cleared
ClearedStraumann Immediate Temporary Abutments
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 Mar 18, 2021 as substantially equivalent to K122192 (Straumann USA, LLC, 2012) and 4 other predicates after a 269-day review. Its family tree reaches back 18 generations to 1996.
- Decided
- Mar 18, 2021
- Review
- 269 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K960026 (1996). 161 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 14 generations between
- 3 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 2 generations backK181703 Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018
- 1 generation backK192401 Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020
- This deviceK201681 Straumann Immediate Temporary AbutmentsInstitut Straumann AG · 2021
Show all 18 generations
- Root · 18 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 17 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 16 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 15 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 11 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 10 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 9 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 8 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 7 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 6 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 5 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 4 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 3 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 2 generations backK181703 Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsInstitut Straumann AG · 2018
- 1 generation backK192401 Straumann Screw-Retained AbutmentsStraumann USA, LLC · 2020
- This deviceK201681 Straumann Immediate Temporary AbutmentsInstitut Straumann AG · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −17 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −11 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −10 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −9 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −8 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −7 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −6 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −5 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −4 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −3 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| −2 | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | Institut Straumann AG | 2018 | — |
| −1 | K192401 | Straumann Screw-Retained Abutments | Straumann USA, LLC | 2020 | — |
| 0 (this device) | K201681 | Straumann Immediate Temporary Abutments | Institut Straumann AG | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1992 | 2 | 0 |
| 1993 | 4 | 0 |
| 1994 | 5 | 0 |
| 1995 | 5 | 0 |
| 1996 | 11 | 0 |
| 1997 | 4 | 0 |
| 1998 | 5 | 0 |
| 1999 | 9 | 0 |
| 2000 | 8 | 0 |
| 2001 | 14 | 0 |
| 2002 | 16 | 0 |
| 2003 | 12 | 0 |
| 2004 | 10 | 0 |
| 2005 | 3 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 4 | 0 |
| 2009 | 5 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (5)
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 |
|---|---|---|---|
| * | K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary…Summary page 4…: Endosseous Dental Implant Abutments Regulatory Class: II (21 CFR 872.3630) Product Code: NHA (21 CFR 872.3630) 5.3 Predicate Device Primary Predicate: K122192 – Straumann Temporary Abutments, PMMA Reference Predicate: K192401 – Straumann Screw Retained Abutments K181703 – BLX Implant Sys… | 2012 |
| * | K192401 | Straumann Screw-Retained AbutmentsSummary page 4…CFR 872.3630) Product Code: NHA (21 CFR 872.3630) 5.3 Predicate Device Primary Predicate: K122192 – Straumann Temporary Abutments, PMMA Reference Predicate: K192401 – Straumann Screw Retained Abutments K181703 – BLX Implant System K190662 – MRI Compatibility for Existing Straumann Dental Impla… | 2020 |
| * | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic AbutmentsSummary page 4…CFR 872.3630) 5.3 Predicate Device Primary Predicate: K122192 – Straumann Temporary Abutments, PMMA Reference Predicate: K192401 – Straumann Screw Retained Abutments K181703 – BLX Implant System K190662 – MRI Compatibility for Existing Straumann Dental Implant System K041070 – Straumann Temporary Copin… | 2018 |
| * | K190662 | MRI Compatibility for Existing Straumann Dental Implant SystemsSummary page 4…te Device Primary Predicate: K122192 – Straumann Temporary Abutments, PMMA Reference Predicate: K192401 – Straumann Screw Retained Abutments K181703 – BLX Implant System K190662 – MRI Compatibility for Existing Straumann Dental Implant System K041070 – Straumann Temporary Coping Straumann USA, LLC… | 2019 |
| * | K041070 | Straumann Temporary CopingSummary page 4…A Reference Predicate: K192401 – Straumann Screw Retained Abutments K181703 – BLX Implant System K190662 – MRI Compatibility for Existing Straumann Dental Implant System K041070 – Straumann Temporary Coping Straumann USA, LLC March 17, 2021 5-1… | 2004 |
What descends from it?
No later submission names this one as a predicate yet.
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 25 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 16 of the 161 ancestors have a recall of any class.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
The Straumann Immediate Temporary Abutment and associated Plastic Coping are indicated to be placed into Straumann dental implants (BL, BLT or BLX) to provide a support structure for a temporary aesthetic oral rehabilitation of partially edentulous patients with crowns. Temporary components can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase for up to 180 days.
The Straumann Immediate Temporary Abutment and associated Plastic Coping must be placed out of occlusion.
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/K201681 · printed Nov 3, 2026
Cite this page
510(k) Report. “K201681: Straumann Immediate Temporary Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K201681
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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