510(k) · Cleared
ClearediPhysio® System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Euroteknika · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 4, 2025 as substantially equivalent to K192893 (Institut Straumann AG, 2020) and 5 other predicates after a 574-day review. Its family tree reaches back 19 generations to 1996.
- Decided
- Mar 4, 2025
- Review
- 574 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 19 generations to K960026 (1996). 412 ancestors in all, the oldest K781060 (1978). No later device cites it as a predicate yet.
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 15 generations between
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- This deviceK232383 iPhysio® SystemEuroteknika · 2025
Show all 19 generations
- Root · 19 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 18 generations backK964330 Biohorizons Dental Implant System (Name Subject to Change)BioHorizons Implant Systems, Inc. · 1997
- 17 generations backK972313 The Maestro SystemBioHorizons Implant Systems, Inc. · 1997
- 16 generations backK020133 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 15 generations backK020645 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 14 generations backK022795 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2002
- 13 generations backK030463 Modification to the Maestro SystemBioHorizons Implant Systems, Inc. · 2003 · Recalled
- 12 generations backK032351 The Maestro System 3.0MM Diameter ImplantBioHorizons Implant Systems, Inc. · 2003
- 11 generations backK041938 Maximus OS (Overdenture System)BioHorizons Implant Systems, Inc. · 2004 · Recalled
- 10 generations backK063364 Alpha Bio Dental Implant SystemAlpha-Bio Tec, Ltd. · 2007
- 9 generations backK081653 Mdi Mii One-Piece Implant, 2.9MMImtec Corp. · 2008 · Recalled
- 8 generations backK123022 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2013
- 7 generations backK133510 Neodent Implant SystemJj Industria E Comercio DE Materiais Dentarios SA · 2014
- 6 generations backK133592 Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua…Neodent USA, Inc. · 2014
- 5 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 4 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 3 generations backK173908 DESS Dental Smart SolutionsTerrats Medical SL · 2018
- 2 generations backK191986 DESS Dental Smart SolutionsTerrats Medical SL · 2019
- 1 generation backK212628 DESS Dental Smart SolutionsTerrats Medical SL · 2022
- This deviceK232383 iPhysio® SystemEuroteknika · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K960026 | Biohorizons Dental Implant System | BioHorizons Implant Systems, Inc. | 1996 | — |
| −18 | K964330 | Biohorizons Dental Implant System (Name Subject to Change) | BioHorizons Implant Systems, Inc. | 1997 | — |
| −17 | K972313 | The Maestro System | BioHorizons Implant Systems, Inc. | 1997 | — |
| −16 | K020133 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −15 | K020645 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −14 | K022795 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2002 | — |
| −13 | K030463 | Modification to the Maestro System | BioHorizons Implant Systems, Inc. | 2003 | 1 |
| −12 | K032351 | The Maestro System 3.0MM Diameter Implant | BioHorizons Implant Systems, Inc. | 2003 | — |
| −11 | K041938 | Maximus OS (Overdenture System) | BioHorizons Implant Systems, Inc. | 2004 | 2 |
| −10 | K063364 | Alpha Bio Dental Implant System | Alpha-Bio Tec, Ltd. | 2007 | — |
| −9 | K081653 | Mdi Mii One-Piece Implant, 2.9MM | Imtec Corp. | 2008 | 1 |
| −8 | K123022 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2013 | — |
| −7 | K133510 | Neodent Implant System | Jj Industria E Comercio DE Materiais Dentarios SA | 2014 | — |
| −6 | K133592 | Neodent Implant System, Titamax TI EX Acqua and TI Drive Acqua, Titamax Smart… | Neodent USA, Inc. | 2014 | — |
| −5 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −4 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −3 | K173908 | DESS Dental Smart Solutions | Terrats Medical SL | 2018 | — |
| −2 | K191986 | DESS Dental Smart Solutions | Terrats Medical SL | 2019 | — |
| −1 | K212628 | DESS Dental Smart Solutions | Terrats Medical SL | 2022 | — |
| 0 (this device) | K232383 | iPhysio® System | Euroteknika | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 3 | 0 |
| 1992 | 5 | 0 |
| 1993 | 13 | 0 |
| 1994 | 14 | 0 |
| 1995 | 15 | 0 |
| 1996 | 17 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 12 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 20 | 0 |
| 2003 | 18 | 0 |
| 2004 | 20 | 0 |
| 2005 | 17 | 0 |
| 2006 | 23 | 0 |
| 2007 | 31 | 0 |
| 2008 | 23 | 0 |
| 2009 | 20 | 0 |
| 2010 | 15 | 0 |
| 2011 | 14 | 0 |
| 2012 | 12 | 0 |
| 2013 | 7 | 0 |
| 2014 | 5 | 0 |
| 2015 | 4 | 0 |
| 2016 | 1 | 0 |
| 2017 | 7 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 3 | 0 |
| 2022 | 2 | 0 |
| 2023 | 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? (6)
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 |
|---|---|---|---|
| * | K192893 | Straumann Ceramic Healing AbutmentsSummary page 6…SecureBME.com Trade Name iPhysio® System Common Name Abutment, Implant, Dental Endosseous Code – NHA Classification 21 CFR §872.3630: Class II Predicate K192893 Straumann® Ceramic Healing Abutments Device Reference K220022 Sigma Biomedical TRATE Dental Implant System Devices K1… | 2020 |
| * | K220022 | TRATE Dental Implant SystemSummary page 6…Implant, Dental Endosseous Code – NHA Classification 21 CFR §872.3630: Class II Predicate K192893 Straumann® Ceramic Healing Abutments Device Reference K220022 Sigma Biomedical TRATE Dental Implant System Devices K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments… | 2022 |
| * | K173374 | TSV BellaTek Encode Healing AbutmentsSummary page 6…§872.3630: Class II Predicate K192893 Straumann® Ceramic Healing Abutments Device Reference K220022 Sigma Biomedical TRATE Dental Implant System Devices K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments K212628 Terrats Medical SL DESS Dental Smart Solutions… | 2017 |
| * | K212628 | DESS Dental Smart SolutionsSummary page 6…Device Reference K220022 Sigma Biomedical TRATE Dental Implant System Devices K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments K212628 Terrats Medical SL DESS Dental Smart Solutions K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent… | 2022 |
| * | K231803 | Neodent Implant System - Zirconia Implant System Cleared while this submission was under review Summary page 6…stem Devices K173374 Biomet 3i, Inc. TSV™ BellaTek® Encode® Healing Abutments K212628 Terrats Medical SL DESS Dental Smart Solutions K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent Implant System - Zirconia Implant System… | 2023 |
| * | K220200 | Paltop Conical Implant SystemSummary page 6…Smart Solutions K231803 JJGC Industria e Comercio de Materiais Dentarios SA Neodent Implant System - Zirconia Implant System K220200 Paltop Advanced Dental Solutions, Ltd Paltop Conical Implant System Reference K071370 Nobel Biocare AB NobelActive Internal… | 2022 |
| † | K071370 | Nobelactive Internal Connection Implant | 2007 |
| † | K073142 | Nobelreplace Hexagonal Implant | 2008 |
| † | K173418 | NobelParallel Conical Connection | 2019 |
| † | K121131 | BL, 04.1 MM RC, Slactive 8MM, Tizr and 10MM, 12, 14MM | 2012 |
| † | K140878 | Straumann Bone Level Tapered Implant | 2014 |
| † | K083550 | Straumann Dental Implant System | 2009 |
| † | K133339 | Zimmer Dental Tapered Screw Vent T Implant, HA Coated;Zimmer Dental Tapered Screw-Vent M… | 2014 |
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 10 months on median.
- 52 of the 412 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. 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?
Indications for Use for iPhysio® Profile Designer: iPhysio® System Profile Designers are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with compatible implant connections. The healing abutments are intended for use up to 6 months. Indications for Use…
Read the full statement (122 words)
Indications for Use for iPhysio® Profile Designer:
iPhysio® System Profile Designers are indicated to be placed in the patient's mouth at the end of the implant placement to protect the inner configuration of the implant and maintain, stabilize and form the soft tissue during the healing process. The healing abutments should be used only with compatible implant connections. The healing abutments are intended for use up to 6 months.
Indications for Use for iPhysio® PEEK Temporary Abutment:
The iPhysio® System PEEK Temporary Abutment is an abutment placed on the iPhysio® System Profile Designer to provide support for prosthetic structures for up to 6 months. It can be used in single- or two-stage procedures and is intended to be placed out of occlusion.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K232383: iPhysio® System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K232383
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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