510(k) · Cleared
ClearedNUVENTUS NV.C™ Prosthetic Components
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Infinitum Eta, Ltd. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Jul 28, 2025 as substantially equivalent to K071370 (Nobel Biocare AB, 2007) and 4 other predicates after a 98-day review. Its family tree reaches back 17 generations to 1996.
- Decided
- Jul 28, 2025
- Review
- 98 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 17 generations to K960026 (1996). 142 ancestors in all, the oldest K874590 (1988). No later device cites it as a predicate yet.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 1 generation backK220751 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022
- This deviceK251220 NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025
Show all 17 generations
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 16 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 15 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 14 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 12 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 11 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 10 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 9 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 8 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 7 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 6 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 5 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 4 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 3 generations backK150182 Neodent Implant System- CM Drive ImplantsJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK173961 Straumann BLX Implant SystemInstitut Straumann AG · 2018
- 1 generation backK220751 Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMAInstitut Straumann AG · 2022
- This deviceK251220 NUVENTUS NV.C™ Prosthetic ComponentsInfinitum Eta, Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −16 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −15 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −14 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −12 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −11 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −10 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −9 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −8 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −7 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −6 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −5 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −4 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −3 | K150182 | Neodent Implant System- CM Drive Implants | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K173961 | Straumann BLX Implant System | Institut Straumann AG | 2018 | — |
| −1 | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMA | Institut Straumann AG | 2022 | — |
| 0 (this device) | 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 |
| 1992 | 1 | 0 |
| 1993 | 4 | 0 |
| 1994 | 4 | 0 |
| 1995 | 4 | 0 |
| 1996 | 9 | 0 |
| 1997 | 4 | 0 |
| 1998 | 3 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2001 | 13 | 0 |
| 2002 | 16 | 0 |
| 2003 | 11 | 0 |
| 2004 | 10 | 0 |
| 2005 | 4 | 0 |
| 2006 | 5 | 0 |
| 2007 | 6 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 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? (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 |
|---|---|---|---|
| * | K071370 | Nobelactive Internal Connection ImplantSummary page 6…vision of Health Technology 1 B (Dental and ENT Devices) III. PREDICATE DEVICE INFORMATION PRIMARY PREDICATE DEVICE - K071370; Nobel Biocare AB, Healing abutment conical connection NP, RP; Cover screw conical connection NP, RP, Temporary abutments and cop… | 2007 |
| * | K220751 | Straumann BLX Temporary Abutment, VITA CAD-Temp, PMMASummary page 6…RIMARY PREDICATE DEVICE - K071370; Nobel Biocare AB, Healing abutment conical connection NP, RP; Cover screw conical connection NP, RP, Temporary abutments and copings - K220751; Institut Straumann AG, Straumann® BLX Temporary Ti Abutment - K132746; Nobel Biocare AB, Clinical Screw CC NP/RP - K161416; Nobe… | 2022 |
| * | K132746 | Nobelprocera Angulated Screw Channel Abutment Conical ConnectionSummary page 6…onical connection NP, RP; Cover screw conical connection NP, RP, Temporary abutments and copings - K220751; Institut Straumann AG, Straumann® BLX Temporary Ti Abutment - K132746; Nobel Biocare AB, Clinical Screw CC NP/RP - K161416; Nobel Biocare AB, Multi Unit Abutment Plus - K113410; Institut Straumann AG… | 2014 |
| * | K161416 | Multi-unit Abutment PlusSummary page 6…ion NP, RP, Temporary abutments and copings - K220751; Institut Straumann AG, Straumann® BLX Temporary Ti Abutment - K132746; Nobel Biocare AB, Clinical Screw CC NP/RP - K161416; Nobel Biocare AB, Multi Unit Abutment Plus - K113410; Institut Straumann AG, Straumann® Multi-base abutment coping Ti === Page… | 2017 |
| * | K113410 | NNC Solid Abutment NNC Temporary Coping for Colid Abutment NNC Temporary Cap for Colid…Summary page 6…Institut Straumann AG, Straumann® BLX Temporary Ti Abutment - K132746; Nobel Biocare AB, Clinical Screw CC NP/RP - K161416; Nobel Biocare AB, Multi Unit Abutment Plus - K113410; Institut Straumann AG, Straumann® Multi-base abutment coping Ti INFINITUM ETA LTD. IV. SUBJECT DEVICE DESCRIPT… | 2012 |
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 29 years and passes through 8 companies; a new generation was cleared every 9 months on median.
- 19 of the 142 ancestors have a recall of any class.
- 28 other devices also cite its predicate K071370.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days. NUVENTUS NV.C™ temporary prosthetic components are indicated to be used prior to the insertion of the final…
Read the full statement (174 words)
NUVENTUS NV.C™ healing components are indicated to be placed in fully or partially edentulous patients after implant placement. The healing components protect the inner configuration of the implant and form, maintain, and stabilize the soft tissue during the healing process. Healing components have a maximum duration of usage of 180 days.
NUVENTUS NV.C™ 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. Temporary prosthetic components have a maximum duration of usage of 180 days.
NUVENTUS NV.C™ Multi-unit Abutments are indicated to be placed into NUVENTUS NV.C™ dental implants to provide a support structure for the functional and esthetic oral rehabilitation of fully or partially edentulous patients with bridges or full-arch prostheses.
NUVENTUS NV.C™ Multi-unit Final Coping is connected to the endosseous dental implant via multi-unit abutment and are indicated for use as an aid in prosthetic rehabilitations in fully or partially edentulous patients with bridges or full-arch prostheses.
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/K251220 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251220: NUVENTUS NV.C™ Prosthetic Components.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251220
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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