510(k) · Cleared
ClearedIPD Dental Implant Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Implant Protesis Dental 2004, S.L. · NHA Abutment, Implant, Dental, Endosseous
Cleared on Oct 21, 2022 as substantially equivalent to K201860 (Elos Medtech Pinol A/S, 2021) after an 88-day review. Its family tree reaches back 19 generations to 1996. 4 later devices descend from it.
- Decided
- Oct 21, 2022
- Review
- 88 days
- Class
- Class II
- Product code
- NHA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 19 generations to K960026 (1996). 320 ancestors in all, the oldest K781060 (1978). 4 later devices descend from it, 1 citing it directly.
- 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 backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 1 generation backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- This deviceK222215 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2022
- Descendant · cites it directly · 3 of its ownK231413 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2023
- Descendant · 2 generations on · 2 of its ownK240570 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024
- Descendant · 3 generations on · 1 of its ownK242819 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024
- Descendant · 4 generations on · 0 of its ownK251471 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 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 backK191919 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2020
- 1 generation backK201860 Elos Accurate Hybrid BaseElos Medtech Pinol A/S · 2021
- This deviceK222215 IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2022
Most influential descendants
Showing 4 of 4 · See all- K231413IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2023 · cites it directly3descendants
- K240570IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024 · 2 generations on2descendants
- K242819IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2024 · 3 generations on1descendant
- K251471IPD Dental Implant AbutmentsImplant Protesis Dental 2004, S.L. · 2025 · 4 generations on0descendants
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 | K191919 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2020 | — |
| −1 | K201860 | Elos Accurate Hybrid Base | Elos Medtech Pinol A/S | 2021 | — |
| 0 (this device) | K222215 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2022 | — |
| +1 | K231413 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2023 | — |
| +2 | K240570 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024 | — |
| +3 | K242819 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2024 | — |
| +4 | K251471 | IPD Dental Implant Abutments | Implant Protesis Dental 2004, S.L. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 1 | 0 |
| 1992 | 4 | 0 |
| 1993 | 12 | 0 |
| 1994 | 12 | 0 |
| 1995 | 15 | 0 |
| 1996 | 16 | 0 |
| 1997 | 7 | 0 |
| 1998 | 8 | 0 |
| 1999 | 11 | 0 |
| 2000 | 11 | 0 |
| 2001 | 18 | 0 |
| 2002 | 19 | 0 |
| 2003 | 17 | 0 |
| 2004 | 16 | 0 |
| 2005 | 14 | 0 |
| 2006 | 17 | 0 |
| 2007 | 23 | 0 |
| 2008 | 14 | 0 |
| 2009 | 13 | 0 |
| 2010 | 10 | 0 |
| 2011 | 10 | 0 |
| 2012 | 5 | 0 |
| 2013 | 3 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 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 |
|---|---|---|---|
| * | K201860 | Elos Accurate Hybrid BaseSummary page 4…(21 CFR 872.3630) Regulatory Class: Class II Product Code(s): Primary: NHA; Secondary: PNP. III. PREDICATE DEVICE(S): Primary Predicate: K201860 Elos Accurate® Hybrid Base™ Reference Devices: K170588 DESS Dental Smart Solutions K153521 I… | 2021 |
| † | K170588 | DESS Dental Smart Solutions | 2017 |
| † | K153521 | IH Implant System | 2016 |
| † | K173908 | DESS Dental Smart Solutions | 2018 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231413 | IPD Dental Implant Abutments | 2023 | 3 |
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 9 companies; a new generation was cleared every 10 months on median.
- 43 of the 320 ancestors have a recall of any class.
- Of its descendants, K231413 (Implant Protesis Dental 2004, S.L., 2023) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K201860.
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?
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations. Compatible Implant Systems Implant System Compatibility Implant Diameter (mm) Platform Diameter 3.5 NP (3.5 mm) Brånemark 3.75 / 4.0 RP (4.1 mm) 5.0 WP (5.1 mm) 3.3 / 4.1 / 4.8 RN (4.8 mm) Straumann® Tissue Level 4.8 WN (6.5 mm) 3.7 / 4.1 3.5 mm…
Read the full statement (137 words)
IPD Dental Implant Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single or multiple dental prosthetic restorations.
Compatible Implant Systems
Implant System Compatibility Implant Diameter (mm) Platform Diameter
3.5 NP (3.5 mm)
Brånemark 3.75 / 4.0 RP (4.1 mm)
5.0 WP (5.1 mm)
3.3 / 4.1 / 4.8 RN (4.8 mm)
Straumann® Tissue Level
4.8 WN (6.5 mm)
3.7 / 4.1 3.5 mm
Tapered Screw-Vent® 4.7 4.5 mm
6.0 5.7 mm
The zirconia superstructures for use with the Ti Base (Interface) are only intended to be designed and manufactured according to digital dentistry workflow. The workflow system integrates multiple components of the digital dentistry workflow: scan files from intra-oral scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222215 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222215: IPD Dental Implant Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222215
Report an extraction error
Are you the manufacturer?
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