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 Oct 26, 2022 as substantially equivalent to K183518 (Preat Corporation, 2019) after a 219-day review. Its family tree reaches back 17 generations to 1996. 1 later device descends from it. It has been recalled 6 times.
- Decided
- Oct 26, 2022
- Review
- 219 days
- Class
- Class II
- Product code
- NHA
- Recalls
- 6
- Predicates
- 1
Its longest line of descent runs back 17 generations to K960026 (1996). 356 ancestors in all, the oldest K781060 (1978). 1 later device descends from it, 1 citing it directly.
- Root · 17 generations backK960026 Biohorizons Dental Implant SystemBioHorizons Implant Systems, Inc. · 1996
- 13 generations between
- 3 generations backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- This deviceK220823 Preat AbutmentsPreat Corporation · 2022
- Descendant · cites it directly · 0 of its ownK243824 Preat AbutmentsPreat Corporation · 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 backK150367 Neodent Implant SystemJjgc Industria E Comercio DE Materiais Dentarios S · 2015
- 2 generations backK170588 DESS Dental Smart SolutionsTerrats Medical SL · 2017
- 1 generation backK183518 Preat AbutmentsPreat Corporation · 2019 · Recalled
- This deviceK220823 Preat AbutmentsPreat Corporation · 2022
Most influential descendants
Showing 1 of 1 · See all- K243824Preat AbutmentsPreat Corporation · 2025 · cites it directly0descendants
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 | K150367 | Neodent Implant System | Jjgc Industria E Comercio DE Materiais Dentarios S | 2015 | — |
| −2 | K170588 | DESS Dental Smart Solutions | Terrats Medical SL | 2017 | — |
| −1 | K183518 | Preat Abutments | Preat Corporation | 2019 | 3 |
| 0 (this device) | K220823 | Preat Abutments | Preat Corporation | 2022 | — |
| +1 | K243824 | Preat Abutments | Preat Corporation | 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 | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K183518 | Preat AbutmentsSummary page 4…ign principles to the following predicate and reference devices: 510(k) Predicate Device Name Company Name K183518 Preat Abutments Preat Corporation 510(k) Refe… | 2019 |
| † | K120414 | Osseospeed Plus | 2012 |
| † | K051614 | Primaconnex Internal Connection Implant System, Primaconnex Internal Connection… | 2005 |
| † | K163194 | Neodent Implant System - GM Line | 2017 |
| † | K180536 | Neodent Implant System – GM Line | 2018 |
| † | K201225 | Neodent Implant System - GM Helix Implants 7.0 | 2020 |
| † | K102436 | Nobel Active 3.0 | 2010 |
| † | K173961 | Straumann BLX Implant System | 2018 |
| † | K181703 | Straumann BLX Line Extension - Implants, SRAs and Anatomic Abutments | 2018 |
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 |
|---|---|---|---|
| K243824 | Preat Abutments | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 24, 2025 | Class II | Z-2107-2025 | Employee error | Due to manufacturing error, digital analog rotational feature is 180 degrees off. |
| Apr 10, 2024 | Class II | Z-2318-2024 | Process control | Due to incorrect milled titanium abutment being packaged and labeled. |
| Jul 18, 2023 | Class II | Z-0153-2024 | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| Jul 18, 2023 | Class II | Z-0152-2024 | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| Jul 18, 2023 | Class II | Z-0154-2024 | Process change control | The healing abutments contain a dimensional condition that may lead to a gap between the healing abutment and the implant allowing for microleakage |
| Feb 21, 2023 | Class II | Z-1285-2023 | Process design | Engaging titanium base contains a dimensional condition that allows vertical movement of the titanium base after the prosthetic screw is torqued to the recommended value, which if undetected and installed on the implant, may lead to… |
The 5 latest of 6 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 49 of the 356 ancestors have a recall of any class.
- Of its descendants, K243824 (Preat Corporation, 2025) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K183518.
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?
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 the mesostructured components make up a two-piece abutment.
All digitally designed custom abutments, superstructures, and/or hybrid crowns for use with Titanium Bases or Titanium Blanks are to be sent to a Preat validated milling center for manufacture.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220823 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220823: 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/K220823
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