510(k) · Cleared
ClearedStraumann BLX Temporary Abutment, VITA CAD-Temp, PMMA
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 2, 2022 as substantially equivalent to K173961 (Institut Straumann AG, 2018) after a 79-day review. Its family tree reaches back 16 generations to 1996. 1 later device descends from it.
- Decided
- Jun 2, 2022
- Review
- 79 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K960026 (1996). 121 ancestors in all, the oldest K874590 (1988). 1 later device descends from it, 1 citing it directly.
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 12 generations between
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- This deviceK220751 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022
- Descendant · cites it directly · 0 of its ownK251220 NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025
Show all 16 generations
- Root · 16 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 14 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 13 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 10 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 9 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 8 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 7 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 6 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 5 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 4 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 3 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 2 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- This deviceK220751 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022
Most influential descendants
Showing 1 of 1 · See all- K251220NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −15 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −13 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −10 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −9 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −8 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −7 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −6 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −5 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −4 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −3 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −2 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| 0 (this device) | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022 | — |
| +1 | K251220 | NUVENTUS NV.C™ Prosthetic Components | Infinitum Eta, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 8 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 12 | 0 |
| 2002 | 14 | 0 |
| 2003 | 10 | 0 |
| 2004 | 9 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 30.6 · 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? (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 |
|---|---|---|---|
| * | K173961 | Straumann BLX Implant SystemSummary page 5…Straumann® BLX Temporary Abutment, VITA CAD-Temp, PMMA 510(k) Summary 5.3 Predicate Device(s) Primary Predicate: K173961 – Straumann® BLX Implant System – Institut Straumann AG Reference Device: K122192 – Straumann Temporary Abutments, PMMA… | 2018 |
| † | K122192 | NC Temporary Abutment, Cad-Temp, Pmma RC Temporary Abutment, Cad-Temp, Pmma RN Temporary… | 2012 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251220 | NUVENTUS NV.C™ Prosthetic Components | 2025 | 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 26 years and passes through 7 companies; a new generation was cleared every 9 months on median.
- 13 of the 121 ancestors have a recall of any class.
- Of its descendants, K251220 (Infinitum Eta, Ltd., 2025) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K173961.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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?
Straumann® temporary prosthetic components are indicated to be used prior to the insertion of the final components to
maintain, stabilize, and shape the soft tissue during the healing phase. They must not be placed in occlusion.
Straumann® temporary abutments are indicated to be placed into Straumann® dental implants to provide a support
structure for the functional and esthetic oral rehabilitation of partially edentulous patients with temporary crowns and
bridges.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220751 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220751: Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220751
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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