510(k) · Cleared
Recalled · Class II · 2025Preat Abutments
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Preat Corporation · NHA Abutment, Implant, Dental, Endosseous
Cleared on Mar 18, 2019 as substantially equivalent to K170588 (Terrats Medical SL, 2017) and 4 other predicates after a 90-day review. Its family tree reaches back 16 generations to 1996. 22 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 18, 2019
- Review
- 90 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 3
- Predicates
- 5
Its longest line of descent runs back 16 generations to K960026 (1996). 355 ancestors in all, the oldest K781060 (1978). 22 later devices descend from it, 4 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 backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK183518 Preat AbutmentsPreat Corporation · 2019
- Descendant · cites it directly · 8 of its ownK193096 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020
- Descendant · cites it directly · 6 of its ownK200817 URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020
- Descendant · 2 generations on · 5 of its ownK211921 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021
- Descendant · 3 generations on · 4 of its ownK222231 S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · Recalled
- Descendant · cites it directly · 3 of its ownK193335 SherlockOpen Implants, LLC · 2020
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 backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 1 generation backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- This deviceK183518 Preat AbutmentsPreat Corporation · 2019
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K193096S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2020 · cites it directly8descendants
- K200817URIS OMNI Narrow System & ProstheticTruabutment, Inc. · 2020 · cites it directly6descendants
- K211921S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2021 · 2 generations on5descendants
- K222231S.I.N. Dental Implant SystemS.I.N. - Sistema DE Implante Nacional S.A. · 2022 · 3 generations on4descendants
- K193335SherlockOpen Implants, LLC · 2020 · cites it directly3descendants
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 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −1 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| 0 (this device) | K183518 | Preat Abutments | Preat Corporation | 2019 | — |
| +1 | K193096 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2020 | — |
| +1 | K200817 | URIS OMNI Narrow System & Prosthetic | Truabutment, Inc. | 2020 | — |
| +2 | K211921 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2021 | — |
| +3 | K222231 | S.I.N. Dental Implant System | S.I.N. - Sistema DE Implante Nacional S.A. | 2022 | 1 |
| +1 | K193335 | Sherlock | Open Implants, LLC | 2020 | — |
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 | 19 | 0 |
| 2003 | 18 | 0 |
| 2004 | 18 | 0 |
| 2005 | 16 | 0 |
| 2006 | 19 | 0 |
| 2007 | 26 | 0 |
| 2008 | 18 | 0 |
| 2009 | 19 | 0 |
| 2010 | 13 | 0 |
| 2011 | 12 | 0 |
| 2012 | 6 | 0 |
| 2013 | 4 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 4 | 0 |
| 2023 | 5 | 0 |
| 2024 | 1 | 0 |
| 2025 | 7 | 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 |
|---|---|---|---|
| * | K170588 | DESS Dental Smart SolutionsSummary page 5…de NHA Classification Panel Dental Products Panel Reviewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit… | 2017 |
| * | K120414 | Osseospeed PlusSummary page 5…ewing Branch Dental Devices Branch PREDICATE DEVICE INFORMATION Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit Abutment Plus, Nobel Biocare AB K151621, BioHorizons CAD/CAM Abutments, BioH… | 2012 |
| * | K161416 | Multi-unit Abutment PlusSummary page 5…anch PREDICATE DEVICE INFORMATION Primary Predicate K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit Abutment Plus, Nobel Biocare AB K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. K100993, In… | 2017 |
| * | K151621 | BioHorizons CAD/CAM AbutmentsSummary page 5…K170588, DESS Dental Smart Solutions, Terrats Medical SL Reference Devices K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit Abutment Plus, Nobel Biocare AB K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed™, P… | 2016 |
| * | K100993 | Inclusive Titanium Abutments for Astra Tech Osseospeed ImplantsSummary page 5…es K120414, OsseoSpeed™ Plus, Astra Tech AB K161416, Multi-unit Abutment Plus, Nobel Biocare AB K151621, BioHorizons CAD/CAM Abutments, BioHorizons Implant Systems, Inc. K100993, Inclusive® Titanium Abutments for Astra OsseoSpeed™, Prismatik Dentalcraft, Inc. 510(k) Summary… | 2010 |
What descends from it? (22)
See all 224 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 25, 2025 | Class II | Z-2514-2025 | Process control | Engaging titanium base was manufactured 180 degrees around the post from where it should be located in relation to the connection geometry; if the flat is on the wrong side of the post, the crown will not fit onto the abutment in the… |
| Apr 2, 2025 | Class II | Z-1987-2025 | Process control | Due to manufacturing issues, abutment products were manufactured with screw seat located too high, which may cause the mating screw to have a shorter engagement length into the associated implant. |
| Feb 9, 2024 | Class II | Z-1321-2024 | Process change control | Due to a manufacturing issue, the screw seat location on the abutment product may be too high, causing mating screw to have a shorter engagement length into the associated implant. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 23 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 48 of the 355 ancestors have a recall of any class.
- Of its descendants, K193096 (S.I.N. - Sistema DE Implante Nacional S.A., 2020) has gone furthest, with 8 descendants of its own.
- 15 other devices also cite its predicate K170588.
How does its category compare?
All NHA devicesNHA Abutment, Implant, Dental, Endosseous: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment. All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or…
Read the full statement (318 words)
Preat Abutments are intended to be used in conjunction with endosseous dental implants in the maxillary or mandibular arch to provide support for single-unit or multi-unit prosthetic restorations. The Titanium Base abutments consists of two major parts. Specifically, the titanium base and mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Base or Titanium Blank are to be sent to a Preat validated milling center for manufacture.
Compatible Implant Systems
3i OSSEOTITE® Certain®: implant body diameters 3.25, 4.0, 5.0, and 6.0 mm; implant platform diameters 3.4, 4.1, 5.0, and 6.0 mm.
Astra Tech OsseoSpeed™: implant body diameters 3.0, 3.5, 4.0, 4.5, and 5.0 mm; implant platform diameters 3.0, 3.5/4.0, and 4.5/5.0 mm.
BioHorizons Tapered Internal: implant body diameters 3.0, 3.5, and 4.0 mm; implant platform diameters 3.0, 3.5, and 4.5 mm.
HIOSSEN ET III: implant body diameter 3.5 mm (Mini platform), and 4.0, 4.5, 5.0, 6.0, and 7.0 mm (Regular platform).
Implant Direct Legacy: implant body diameters 3.2, 3.7, 4.2, 4.7, 5.2, 5.7, and 7.0 mm; implant platform diameters 3.0, 3.5, 4.5, and 5.7 mm.
MegaGen AnyRidge: implant body diameters 3.5, 4.0, 4.5, 5.0, and 5.5 mm; implant platform diameter 3.5 mm.
Neoss: implant body diameters 3.5, 4.0, 4.5, 5.0, and 5.5 mm; implant platform diameter 4.1 mm.
NobelActive®: implant body diameter 3.5 mm (NP platform), and 4.3 and 5.0 mm (RP platform).
Nobel Replace™: implant body diameter 3.5 mm (NP platform); 4.0, 4.3, and 5.0 mm (RP platform); 5.0 mm (WP platform); and 6.0 mm (6.0 platform).
Straumann® Bone Level: implant body diameter 3.3 mm (NC platform), and 4.1 and 4.8 mm (RC platform).
Straumann® Tissue Level: implant body diameters 3.3, 4.1, and 4.8 mm (RN platform), and 4.8 and 6.5 mm (WN platform).
Zimmer Screw-Vent®/Tapered Screw-Vent®: implant body diameters 3.3, 3.7, and 4.1 mm (3.5 platform); 4.7 mm (4.5 platform); and 6.0 mm (5.7 platform).
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/K183518 · printed Nov 6, 2026
Cite this page
510(k) Report. “K183518: Preat Abutments.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K183518
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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